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Diss Factsheets
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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
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- 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)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Only raw data were reported, details on test materials are missing. Guideline 402 is followed with deviations.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Only raw data were reported, details on test materials are missing. Guideline 401 is followed with deviations.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- : not always a 14 day observation period.
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- other: water or Tween 80 with water
- Details on oral exposure:
- No data
- Doses:
- - 2000 mg/kg
- 5000 mg/kg - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (not always a 14 day observation period.)
- Frequency of observations and weighing: observations: daily
- Necropsy of survivors performed: yes - Statistics:
- No data
- Preliminary study:
- Not relevant
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 - < 5 000 mg/kg bw
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- < 5 000 mg/kg bw
- Mortality:
- - No animals died following treatment or during the observation period at the 2000 mg/kg dosage.
- All animals died during the observation period at the 5000 mg/kg dosage. Deaths occurred on the first or second day. - Clinical signs:
- other: - All rats generally exhibited normal appearance and behaviour following treatment and during the observation period at the 2000 mg/kg dosage. - Clinical observation data at the 5000 mg/kg dosage: The most frequently observed changes included depression,
- Gross pathology:
- - Animals in the 2000 mg/kg group with water as a vehicle showed no gross abnormalities.
- The observed changes of the gross necropsies performed on animals which died during the observation period included very red lung edges and swollen stomach. - Other findings:
- See table below (Table 7.2.1/1)
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the test conditions of this study, the acute oral median lethal dose to rats of Aluminum sulphate, hydrate was found to be greater than 2000 mg/kg body weight and less than 5000 mg/kg bw. Based on these results, the registered substance is not classified according to the Regulation (EC) N° 1272-2008 (CLP) and classified in classified in category 5 according to the GHS.
- Executive summary:
In an acute oral toxicity study performed with some equivalence to OECD Guideline 401 but not in compliance with GLP, groups (5/sex/dose) of Sprague Dawley rats were given Aluminum sulphate, hydrate at 2000 mg/kg in water or in Tween 80/water to females and 5000 mg/kg in Tween 80/water to males and females.
Animals were then observed for mortality, clinical signs for 14 days in most cases and were all sacrificed for macroscopic examination.
No mortality occurred in all ten females dosed at the 2000 mg/kg level. No clinical changes were observed generally at this dose level. All ten animals at 5000 mg/kg bw died with deaths occurring on the first or second day. Clinical signs of toxicity included depression and ruffled fur. Necropsy findings showed very red lung edges and/or swollen stomach.
The acute oral LD50 for Aluminum sulphate, hydrate was found to be greater than 2000 mg/kg bodyweight and less than 5000 mg/kg bw for females. For males the LD50 is less than 5000 mg/kg. Based on these results, the registered substance was not classified according to the Regulation (EC) N° 1272-2008 (CLP) and classified in category 5 according to the GHS.
Table 7.2.1/1: Results on deaths, clinical and necropsy observations:
Date |
Sex |
Dose (mg/kg) |
Vehicle |
# deaths |
Total # animals |
Clinical observations |
Necropsy observations |
8July1976 |
M |
5000 |
Tween 80 + H2O |
5 |
5 |
Day 1: - Restless - Ruffled fur - Lying in one place - Occasionally readjust positions - React to touch + sound Day 2: - Remaining rat sits in one place, wobbling slightly - Head rests on floor - Eyes sunken + glossy - Fur ruffled |
Day 2: - Lung edges very red - Stomach swollen; content reddish - Yellow liquid filled mouth during necropsy |
|
|
|
|
|
|
|
|
18June1976 |
F |
2000 |
Tween 80 + H2O |
0 |
5 |
Appear normal |
|
13July1976 |
F |
5000 |
Tween 80 + H2O |
5 |
5 |
Day 1: - Mild to severe depression - Slower reacting to sound + touch - Ruffled fur - Walking uncoordinated - Eyes partially closed - Huddled in a pile - Mild lacrimation - 1 animal died Day 2: - Other animals died |
|
03August1976 |
F |
2000 |
H2O |
0 |
5 |
Appear normal |
No gross abnormalities |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- : only 2 males and 2 females tested
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- no
- Remarks:
- pre-GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 006
- Cas Number:
- 17927-65-0
- Molecular formula:
- Al2 (SO4)3, x H2O
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): Aluminum Sulfate, Hydrate
- the sample was received on July 10, 1975
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- No data
- Duration of exposure:
- 24 hours
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 2 males and 2 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: daily; weighing: at start and end of the test
- Necropsy of survivors performed: yes - Statistics:
- No data
Results and discussion
- Preliminary study:
- Not applicable.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred following treatment and during the observation period at the 5000 mg/kg dosage level.
- Clinical signs:
- other: Clinical observation data at the 5000 mg/kg dosage: - Males: mild/moderate erythema. Both appear normal 2 days after treatment. - Females: moderate and severe erythema, small areas of haemorrhaging in places where large chunks of compound were pressed int
- Gross pathology:
- Animals autopsied in the 5000 mg/kg group showed no gross abnormalities, with the exception of 1 male animal which had pale lungs.
- Other findings:
- See Table below (Table 7.2.3/1)
Any other information on results incl. tables
Table 7.2.3/1: results on deaths, clinical and necropsy observations:
Date |
Sex |
Dose (mg/kg) |
# deaths |
Total # animals |
Clinical observations |
Necropsy observations |
15July1976 |
M |
5000 |
0 |
2 |
After unwrapping: - Mild/moderate erythema Day 2: - Appear normal |
One animal with pale lungs, other animal showed no gross abnormalities |
|
|
|
|
|
|
|
15July1976 |
F |
5000 |
0 |
2 |
Day 1: - Moderate and severe erythema - Small areas of haemorrhaging in places where large chunks of compound were pressed into the skin Day 2: - Appear normal |
No gross abnormalities |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, the Single Dose Acute Dermal LD50 of Aluminum Sulfate, Hydrate applied to the skin for 24 hours, is greater than 5000 mg/kg bw. Therefore the test material was not classified according to Regulation EC No.1272/2008 (CLP) and to the GHS.
- Executive summary:
In an acute dermal toxicity study performed with some equivalence to OECD Guideline 402 but not in compliance with GLP, groups (2/sex/dose) of New Zealand White rabbits were tested with a single dermal application of Aluminum Sulfate, Hydrate at 5000 mg/kg bw for 24 hours. Animals were then observed for mortality, clinical signs for 14 days and were all sacrificed for macroscopic examination.
No mortality occurred. All rabbits exhibited normal appearance and behaviour on day 2. However, some skin irritation such as erythema and haemorrhaging were observed.The gross necropsy showed no significant gross changes, with the exception of 1 male animal which had pale lungs.
The Single Dose Acute Dermal LD50 of Aluminum Sulfate, Hydrate applied to the skin for 24 hours, is greater than 5000 mg/kg bw. Therefore the registered substance was not classified according to the Annex VI of 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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