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EC number: 233-135-0 | CAS number: 10043-01-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
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- Endpoint summary
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Combined repeated dose / reproductive screening study (OECD 422): study performed on Aluminium chloride basic relevant for Aluminium sulphate in a read-across approach based on Aluminium (Al3+) toxicity (K, Reliability 1).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 September 2006 - 03 November 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study was conducted according to OECD guideline 422 and under GLP conditions.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Limit test:
- no
- Specific details on test material used for the study:
- - Stability under test conditions: At least 48 hours
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation:
Males: approx. 9 weeks
Females: approx. 11 weeks
- Weight at study initiation: All animals within +/- 20% of the sex mean
- Fasting period before study:
- Housing:
Pre-mating: groups of 5 animals/sex/cage
Mating: 1 male, 1 female
Post-mating: males in groups of 5 animals/sex/cage, females individually
Lactation: offspring together with dam
- Diet (e.g. ad libitum): Ad libitum, pelleted rodent diet
- Water (e.g. ad libitum): Ad libitum, tap-water
- Acclimation period: 4 days prior to start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.9-23.4
- Humidity (%): 37-95
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
Formulations (w/w) were prepared within 4 hours prior to dosing and were homogenised to a visually acceptable level. Adjustment was made for specific gravity of the test substance. No adjustment was made for specific gravity of the vehicle and formulation.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water
- Amount of vehicle (if gavage): 5 ml/kg bw - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Formulated samples were analysed using ICP-MS
- Duration of treatment / exposure:
- Males: 28 days
Females: 37 to 53 days (because of developmental purpose of study) - Frequency of treatment:
- Once daily, 7 days a week
- Dose / conc.:
- 40 mg/kg bw/day (actual dose received)
- Remarks:
- = 3.6 mg/kg bw/day Aluminium
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Remarks:
- = 18 mg/kg bw/day Aluminium
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- = 90 mg/kg bw/day Aluminium
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: Based on the results of a dose range finding study (NOTOX project 473524)
- Rationale for animal assignment (if not random): Random
- Section schedule rationale (if not random): No data - Positive control:
- Not relevant
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: At least twice daily
- Cage side observations checked: Mortality/viability
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: At least once daily
BODY WEIGHT: Yes
- Time schedule for examinations: At start, once weekly and at death (females also at: gestation days 0, 4, 7, 11, 17, 20, lactation day 1, 4)
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes, weekly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No, not recorded, only subjective appraisal
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Immediately prior to scheduled post mortem examination
- Anaesthetic used for blood collection: Yes (Isoflurane)
- Animals fasted: Yes, max. 20 hours overnight
- How many animals: 5 males and 5 females randomly selected from each group
- Parameters checked: see "Any other information on materials and methods incl. tables"
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Immediately prior to scheduled post mortem examination
- Animals fasted: Yes, max. 20 hours overnight
- How many animals: 5 males and 5 females randomly selected from each group
- Parameters checked: see "Any other information on materials and methods incl. tables"
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: Males during week 4, females during lactation
- Dose groups that were examined: 5 males and 5 females, randomly selected from all groups
- Battery of functions tested: hearing ability / pupillary reflex / static righting reflex / grip strength / motor activity test - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, of all organs of all animals
HISTOPATHOLOGY: Yes, examination of following organs from 5 animals/sex/group: see "Any other information on materials and methods incl. tables" - Other examinations:
- Not relevant
- Statistics:
- - Variables with normal distribution: Dunnett-test based on a pooled variance estimate was applied for the comparison of the treated groups and the control groups for each sex
- The steel-test was applied if the data was not assumed to follow a normal distribution
- The Fisher Exact-test was applied to frequency data
All tests were two-sided and in all cases p<0.05 was accepted as the lowest level of significance.
No statistical analysis performed on histopathology findings.
Test statistics were calculated on the basis of exact values for means and pooled variances. - Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs noted. Functional observation battery: all parameters normal in all animals None related to test substance One female sacrificed in extremis due to parturition difficulties on day 22 p.c. Cause of death could not be established
- Mortality:
- no mortality observed
- Description (incidence):
- No clinical signs noted. Functional observation battery: all parameters normal in all animals None related to test substance One female sacrificed in extremis due to parturition difficulties on day 22 p.c. Cause of death could not be established
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slightly lower mean bw for females at 1000 mg/kg bw/d at day 8 with slight weight loss for three of these females. BW recovered during the following mating and post-coital period. In the other groups no deviations compared to controls
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Mean food consumption of females at 1000 mg/kg bw/d slightly lower than controls. Otherwise no deviations compared to controls
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Minor, but statistically significant lowering of MCHC in M and F of 1000 mg/kg bw/g group Minor but statistically significant higer plateled count in males at 1000 mg/kg bw
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Males at 1000 mg/kg bw/d: statistically significant - lower ALP activity - lower albumin levels - higher Potassium levels - higher inorganic phospate levels no deviations in females or in M?F at 40 & 200 mg/kg/d
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Minor changes in brain weight of females at 1000 mg/kg and kidney weight of females at 200 mg/kg were not considered to be relevant or substance-related.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Red foci on glandular mucosa of the stomach in 5/10 males at 1000 mg/kg/day, with thickening of glandular mucosa or limiting ridge in two of these five. No other relevant abnormalities were seen except coagulum in the caecum and enlargement of liver and s
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Mild to moderate subacute inflammation of the glandualr mucosa and minimal to moderate superficial easinophilic spheroids in alle xamined animals of both sexes at 1000 mg/kg bw/d
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN
Slightly lower mean bw for females at 1000 mg/kg bw/d at day 8 with slight weight loss for three of these females. BW recovered during the following mating and post-coital period. In the other groups no deviations compared to controls
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Mean food consumption of females at 1000 mg/kg bw/d slightly lower than controls. Otherwise no deviations compared to controls
HAEMATOLOGY
Minor, but statistically significant lowering of MCHC in M and F of 1000 mg/kg bw/g group
Minor, but statistically significant higher plateled count in males at 1000 mg/kg bw
CLINICAL CHEMISTRY
Males at 1000 mg/kg bw/d: statistically significant
- lower ALP activity
- lower albumin levels
- higher Potassium levels
- higher inorganic phospate levels
no deviations in females or in M/F at 40 & 200 mg/kg/d
GROSS PATHOLOGY
Red foci on glandular mucosa of the stomach in 5/10 males at 1000 mg/kg/day, with thickening of glandular mucosa or limiting ridge in two of these five. No other relevant abnormalities were seen except coagulum in the caecum and enlargement of liver and spleen in the animal sacrificed in extremis.
HISTOPATHOLOGY: NON-NEOPLASTIC
Mild to moderate subacute inflammation of the glandular mucosa and minimal to moderate superficial easinophilic spheroids in alle examined animals of both sexes at 1000 mg/kg bw/day - Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 1000 mg/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 18 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 90 mg Al/kg bw/day
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 90 mg Al/kg bw/day
- Dose descriptor:
- LOAEL
- Effect level:
- 90 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 90 mg Al/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- Al chloride basic
- Sex:
- male
- Basis for effect level:
- other: Systemic effects: haematology, clinical chemistry, gross pathology, histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 90 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- male
- Basis for effect level:
- other: Systemic effects: haematology, clinical chemistry, gross pathology, histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: Local and systemic (HISTOPATHOLOGY EFFECTS at 1000 mg/kg/day)
- Dose descriptor:
- NOAEL
- Effect level:
- 90 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- female
- Basis for effect level:
- other: Local and systemic (HISTOPATHOLOGY EFFECTS at 90 mg Al/kg/day)
- Critical effects observed:
- not specified
- Conclusions:
- In a combined repeated dose / reproductive screening study (OECD 422), administration of Aluminium chloride basic by oral gavage to male and female rats at dose levels of 20, 200 or 1000 mg /kg/d (equivalent to 3.6, 18 and 90 mg/kg bw/d) was studied. No toxic effects were observed in females at any dose. Therefore, the overall NOAEL for female rats was established to be 1000 mg/kg bw/day(equivalent to 90 mg/kg bw/d). For males the NOAEL for local effects was established to be 200 mg/kg bw/day (equivalent to 18 mg/kg bw/d) and for systemic toxicity 1000 mg/kg bw/day aluminium chloride (equivalent to 90 mg/kg bw/d).
- Executive summary:
A combined repeated dose / reproductive screening study (OECD 422), studied the administration of Aluminium chloride basic by oral gavage to male and female Wistar rats at dose levels of 20, 200 or 1000 mg /kg/d (equivalent to 3.6, 18 and 90 mg/kg bw/d). 10 animals/sex/group were used. Males were exposed for 28 days, females between 37 -53 days (because of developmental toxicity purpose of study). Detailed clinical signs, body weight, food consumption, water consumption (subjective appraisal), haematology, clinical chemistry, neurobehaviour and gross and histopathology were studied.
Slightly lower mean bodyweight was observed for females at the 1000 mg/kg bw/day (equivalent to 90 mg/kg bw/d)
group at day 8, with slight weight loss for three of these females. Bodyweight recovered during the following mating and post-coital period. In the other groups no deviations were observed as compared to control.
Mean food consumption of females at 1000 mg/kg bw/day (equivalent to 90 mg/kg bw/d)
was slightly lower than controls. Otherwise no deviations were observed as compared to controls.
Minor, but statistically significant lowering of MCHC was observed in males and females of the 1000 mg/kg bw/day (equivalent to 90 mg/kg bw/d)
group. Minor, but statistically significant higher plateled count was observed in males at a dose of 1000 mg/kg bw/d
(equivalent to 90 mg/kg bw/d).
Males at 1000 mg/kg bw/day had statistically significant lower ALP activity, lower albumin levels, higher Potassium levels, higher inorganic phospate levels. No deviations were observed in females or in males and females at a dose of 40 & 200 mg/kg bw/d (equivalent to 3.6 and 18 mg/kg bw/d).
Red foci on glandular mucosa of the stomach were observed in 5 of 10 males at a dose of 1000 mg/kg/day (equivalent to 90 mg/kg bw/d)
, with thickening of glandular mucosa or limiting ridge in two of these five. No other relevant abnormalities were seen.
Mild to moderate subacute inflammation of the glandular mucosa and minimal to moderate superficial easinophilic spheroids was observed in all examined animals of both sexes at 1000 mg/kg bw/day (equivalent to 90 mg/kg/d Al 3 +).
Based on these results, the overall NOAEL for female rats was established to be 1000 mg/kg bw/day
(equivalent to 90 mg/kg/d Al 3 +).
For males the NOAEL for local effects was established to be 200 mg/kg bw/day and for systemic toxicity 1000 mg/kg bw/day (equivalent to 90 mg/kg/d Al 3 +). In a combined repeated dose / reproductive screening study, administration of Aluminium chloride basic by oral gavage to male and female rats at dose levels of 20, 200 or 1000 mg /kg/d,
From two weeks prior to mating to at least 3 days of lactation (females) or 28 days (males) revealed no toxicity in females at any dose.
The NOAEL for local (stomach) toxicity in males is 200 mg/kg bw/d (equivalent to 18 mg Al3+)
The LOAEL for local (stomach) toxicity in males is 1000 mg/kg bw/d (equivalent to 90 mg Al3+)
The NOAEL for systemic toxicity in males is 1000 mg/kg bw/d (equivalent to 90 mg/kg/d Al3+).
The NOAEL for local and systemic toxicity in females is 1000 mg/kg bw/d (equivalent to 90 mg/kg/d Al3+).
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
Common precursor(s)/breakdown product(s): Al3+ is the substance of biological interest and that the toxicological effects of Aluminium sulphate can be attributed exclusively to Al3+.
2. SOURCE AND TARGET CHEMICAL(S)
Source substance: Aluminum chloride, basic (CAS 1327-41-9)
Target substance: Aluminium sulphate hydrated (CAS No 17927-65-0)
3. ANALOGUE APPROACH JUSTIFICATION
Based on the similar behaviour regarding toxicokinetics, data from the different soluble Aluminium salts are used in read-across approach to assess the toxicological properties of Aluminium sulphate. Hence, the data from the other soluble Aluminium salts are considered as a starting point in the hazard assessment of Aluminium sulphate taking into account the differences in bioavailability using available toxicokinetic information.
4. DATA MATRIX
See attached justification - Reason / purpose for cross-reference:
- read-across source
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical signs noted. Functional observation battery: all parameters normal in all animals None related to test substance One female sacrificed in extremis due to parturition difficulties on day 22 p.c. Cause of death could not be established
- Mortality:
- no mortality observed
- Description (incidence):
- No clinical signs noted. Functional observation battery: all parameters normal in all animals None related to test substance One female sacrificed in extremis due to parturition difficulties on day 22 p.c. Cause of death could not be established
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Slightly lower mean bw for females at 1000 mg/kg bw/d at day 8 with slight weight loss for three of these females. BW recovered during the following mating and post-coital period. In the other groups no deviations compared to controls
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Mean food consumption of females at 1000 mg/kg bw/d slightly lower than controls. Otherwise no deviations compared to controls
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Minor, but statistically significant lowering of MCHC in M and F of 1000 mg/kg bw/g group Minor but statistically significant higer plateled count in males at 1000 mg/kg bw
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Males at 1000 mg/kg bw/d: statistically significant - lower ALP activity - lower albumin levels - higher Potassium levels - higher inorganic phospate levels no deviations in females or in M?F at 40 & 200 mg/kg/d
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- Minor changes in brain weight of females at 1000 mg/kg and kidney weight of females at 200 mg/kg were not considered to be relevant or substance-related.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Red foci on glandular mucosa of the stomach in 5/10 males at 1000 mg/kg/day, with thickening of glandular mucosa or limiting ridge in two of these five. No other relevant abnormalities were seen except coagulum in the caecum and enlargement of liver and s
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Mild to moderate subacute inflammation of the glandualr mucosa and minimal to moderate superficial easinophilic spheroids in alle xamined animals of both sexes at 1000 mg/kg bw/d
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN
Slightly lower mean bw for females at 1000 mg/kg bw/d at day 8 with slight weight loss for three of these females. BW recovered during the following mating and post-coital period. In the other groups no deviations compared to controls
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Mean food consumption of females at 1000 mg/kg bw/d slightly lower than controls. Otherwise no deviations compared to controls
HAEMATOLOGY
Minor, but statistically significant lowering of MCHC in M and F of 1000 mg/kg bw/g group
Minor, but statistically significant higher plateled count in males at 1000 mg/kg bw
CLINICAL CHEMISTRY
Males at 1000 mg/kg bw/d: statistically significant
- lower ALP activity
- lower albumin levels
- higher Potassium levels
- higher inorganic phospate levels
no deviations in females or in M/F at 40 & 200 mg/kg/d
GROSS PATHOLOGY
Red foci on glandular mucosa of the stomach in 5/10 males at 1000 mg/kg/day, with thickening of glandular mucosa or limiting ridge in two of these five. No other relevant abnormalities were seen except coagulum in the caecum and enlargement of liver and spleen in the animal sacrificed in extremis.
HISTOPATHOLOGY: NON-NEOPLASTIC
Mild to moderate subacute inflammation of the glandular mucosa and minimal to moderate superficial easinophilic spheroids in alle examined animals of both sexes at 1000 mg/kg bw/day - Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 1000 mg/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 18 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 90 mg Al/kg bw/day
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 90 mg Al/kg bw/day
- Dose descriptor:
- LOAEL
- Effect level:
- 90 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- male
- Basis for effect level:
- other: Local effects (stomach) at 90 mg Al/kg bw/day
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Remarks:
- Al chloride basic
- Sex:
- male
- Basis for effect level:
- other: Systemic effects: haematology, clinical chemistry, gross pathology, histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 90 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- male
- Basis for effect level:
- other: Systemic effects: haematology, clinical chemistry, gross pathology, histopathology
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- female
- Basis for effect level:
- other: Local and systemic (HISTOPATHOLOGY EFFECTS at 1000 mg/kg/day)
- Dose descriptor:
- NOAEL
- Effect level:
- 90 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Remarks:
- Al 3+
- Sex:
- female
- Basis for effect level:
- other: Local and systemic (HISTOPATHOLOGY EFFECTS at 90 mg Al/kg/day)
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic effects
- Effect level:
- 1 141 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic effects
- Remarks on result:
- other: the NOAEL for systemic effects Aluminium sulphate was calculated at 1141 mg/kg bw/day using the molecular mass of aluminium sulphate as anhydrous of 342.1 g/mol
- Critical effects observed:
- not specified
- Conclusions:
- In a combined repeated dose / reproductive screening study (OECD 422), administration of Aluminium chloride basic by oral gavage to male and female rats at dose levels of 20, 200 or 1000 mg /kg/d (equivalent to 3.6, 18 and 90 mg/kg bw/d) was studied. No toxic effects were observed in females at any dose. Therefore, the overall NOAEL for female rats was established to be 1000 mg/kg bw/day(equivalent to 90 mg/kg bw/d). For males the NOAEL for local effects was established to be 200 mg/kg bw/day (equivalent to 18 mg/kg bw/d) and for systemic toxicity 1000 mg/kg bw/day aluminium chloride (equivalent to 90 mg/kg bw/d).
Based on these results, it is possible to predict the effect following chronic exposure to Aluminium sulphate by reading across from the repeated dose toxicity result on Aluminium Chloride basic. Consequently, the NOAEL for systemic effects Aluminium sulphate was calculated at 1141 mg/kg bw/day using the molecular mass of aluminium sulphate as anhydrous of 342.1 g/mol. - Executive summary:
A combined repeated dose / reproductive screening study (OECD 422), studied the administration of Aluminium chloride basic by oral gavage to male and female Wistar rats at dose levels of 20, 200 or 1000 mg /kg/d (equivalent to 3.6, 18 and 90 mg/kg bw/d). 10 animals/sex/group were used. Males were exposed for 28 days, females between 37 -53 days (because of developmental toxicity purpose of study). Detailed clinical signs, body weight, food consumption, water consumption (subjective appraisal), haematology, clinical chemistry, neurobehaviour and gross and histopathology were studied.
Slightly lower mean bodyweight was observed for females at the 1000 mg/kg bw/day (equivalent to 90 mg/kg bw/d)
group at day 8, with slight weight loss for three of these females. Bodyweight recovered during the following mating and post-coital period. In the other groups no deviations were observed as compared to control.
Mean food consumption of females at 1000 mg/kg bw/day (equivalent to 90 mg/kg bw/d)
was slightly lower than controls. Otherwise no deviations were observed as compared to controls.
Minor, but statistically significant lowering of MCHC was observed in males and females of the 1000 mg/kg bw/day (equivalent to 90 mg/kg bw/d)
group. Minor, but statistically significant higher plateled count was observed in males at a dose of 1000 mg/kg bw/d
(equivalent to 90 mg/kg bw/d).
Males at 1000 mg/kg bw/day had statistically significant lower ALP activity, lower albumin levels, higher Potassium levels, higher inorganic phospate levels. No deviations were observed in females or in males and females at a dose of 40 & 200 mg/kg bw/d (equivalent to 3.6 and 18 mg/kg bw/d).
Red foci on glandular mucosa of the stomach were observed in 5 of 10 males at a dose of 1000 mg/kg/day (equivalent to 90 mg/kg bw/d)
, with thickening of glandular mucosa or limiting ridge in two of these five. No other relevant abnormalities were seen.
Mild to moderate subacute inflammation of the glandular mucosa and minimal to moderate superficial easinophilic spheroids was observed in all examined animals of both sexes at 1000 mg/kg bw/day (equivalent to 90 mg/kg/d Al 3 +).
Based on these results, the overall NOAEL for female rats was established to be 1000 mg/kg bw/day
(equivalent to 90 mg/kg/d Al 3 +).
For males the NOAEL for local effects was established to be 200 mg/kg bw/day and for systemic toxicity 1000 mg/kg bw/day (equivalent to 90 mg/kg/d Al 3 +). In a combined repeated dose / reproductive screening study, administration of Aluminium chloride basic by oral gavage to male and female rats at dose levels of 20, 200 or 1000 mg /kg/d,
From two weeks prior to mating to at least 3 days of lactation (females) or 28 days (males) revealed no toxicity in females at any dose.
The NOAEL for local (stomach) toxicity in males is 200 mg/kg bw/d (equivalent to 18 mg Al3+)
The LOAEL for local (stomach) toxicity in males is 1000 mg/kg bw/d (equivalent to 90 mg Al3+)
The NOAEL for systemic toxicity in males is 1000 mg/kg bw/d (equivalent to 90 mg/kg/d Al3+).
The NOAEL for local and systemic toxicity in females is 1000 mg/kg bw/d (equivalent to 90 mg/kg/d Al3+).
Based on these results, it is possible to predict the effect following chronic exposure to Aluminium sulphate by reading across from the repeated dose toxicity result on Aluminium Chloride basic. Consequently, the NOAEL for systemic effects Aluminium sulphate was calculated at 1141 mg/kg bw/day using the molecular mass of aluminium sulphate as anhydrous of 342.1 g/mol.
Referenceopen allclose all
Not relevant
Not relevant
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 142 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies. The repeated dose toxicity by oral is also covered in the Developmental and One-Year Chronic Neurotoxicity Study of Aluminium Citrate in Rats as the dams are exposed up to 300 mg/kg bw/d of aluminium citrate from day 6 of gestation until weaning (see section of toxicity to reproduction).
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- chronic toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- chronic toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Critical effects observed:
- not specified
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Studies are available with Aluminium sulphate but they focused on specific endpoints which are not considered appropriate to conclude on the overall chronic study of the substance. In addition, there are no reliable studies available on the repeated dose toxicity of aluminium sulphate by the oral, inhalation and dermal route.
In terms of hazard assessment of toxic effects, available data on the repeated dose toxicity of other aluminium soluble salt was taken into account by read-across following a structural analogue approach, since the pathways leading to toxic outcomes are likely to be dominated by the chemistry and biochemistry of the aluminium ion (Al3+) as describedin the toxicokinetic section.
A combined repeated dose / reproductive screening study (OECD 422), studied the administration of Aluminium chloride basic by oral gavage to male and female Wistar rats at dose levels of 20, 200 or 1000 mg /kg bw/dcorresponding to 3.6, 18, 90 mg Al3+/kg bw/day (Beekhuijzen, 2007). Ten animals/sex/group were used. Males were exposed for 28 days, females between 37 -53 days (because of developmental toxicity purpose of study). Detailed clinical signs, body weight, food consumption, water consumption (subjective appraisal), haematology, clinical chemistry, neurobehaviour and gross and histopathology were studied.
From two weeks prior to mating to at least 3 days of lactation (females) or 28 days (males) revealed no toxicity in females at any dose.
While the NOAEL for local (stomach) toxicity in males is 200 mg/kg bw/d (equivalent to 18 mg Al3+), the LOAEL for local (stomach) toxicity in males is 1000 mg/kg bw/d (equivalent to 90 mg Al3+).
However, the NOAEL for systemic toxicity in males and in females are 1000 mg/kg bw/d (equivalent to 90 mg/kg/d Al3+).
The NOAEL for local and systemic toxicity in females is 1000 mg/kg bw/d (equivalent to 90 mg/kg/d Al3+). Based on these results, it is possible to predict the effect following chronic exposure to Aluminium sulphate by reading across from the repeated dose toxicity result on Aluminium Chloride basic. Consequently, the NOAEL for systemic effects Aluminium sulphate was calculated at 1141 mg/kg bw/day using the molecular mass of aluminium sulphate as anhydrous of 342.1 g/mol.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
No guideline Study was available on Aluminum sulphate. Read- across approach using the key study performed on Aluminum chloride and conducted according to OECD guideline 422 in compliance with GLP is considered as adequate to assess the oral repeated dose toxicity of aluminium sulfate (see §"Toxicokinetics").
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available for the repeated dose toxicity by oral and dermal route , by inhalation
Self classification:
Based on available data, Aluminium Sulphate is not classified for the chronic toxicity according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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