Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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)
Endpoint summary
Administrative data
Description of key information
- Skin irritation/corrosion: not irritating (OECD 404, GLP, Kr: 1)
- Eye irritation: Causes serious eye damage (OECD 405, GLP, Kr: 1)
- Respiratory irritation: no data available
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 to 25 February 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP guideline study well conducted.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: approximately twelve to sixteen weeks old.
- Weight at study initiation: 2.24 - 2.68 Kg.
- Housing: individually
- Diet (e.g. ad libitum): Rabbit Diet, Preston Farmers Limited.
- Water (e.g. ad libitum): drinking water
- Acclimation period: five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 68 - 74%
- Air changes (per hr): 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light.
IN-LIFE DATES: no data. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after the patches removal.
- Number of animals:
- Three (1 male and 2 females)
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm gauze patch and placed in position on the shorn skin.
- % coverage: the patch was secured in position with a strip of surgical adhesive tape (BLENDER: approximate size 2.5 cm x 4.0 cm)
- Type of wrap if used: elasticated corset (TUBIGRIP)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours
SCORING SYSTEM: Draize method. - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- Mean Individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- Mean Individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- Mean Individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- Mean Individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- None
- Other effects:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions of this study, the test material ALUM-17 was found to be non-irritant to the rabbit skin. Therefore, no classification is required according to Regulation (EC) N° 1272-2008 (CLP) and the GHS.
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three New Zealand White rabbits were dermally exposed to 0.5 g of ALUM-17 as a powder (analytical purity of min. ) moistened with distilled water (0.5 mL) under a semi-occlusive dressing for 4 h. After removal of the residual test item, skin irritation was scored by the method of Draize (1959) at 24, 48 and 72 h after exposure.
No skin responses were noted during the study. All treated skin sites appeared normal at the 24 h observation. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for erythema and 0, 0, 0 for oedema score, respectively. In this study, ALUM-17 is therefore not a skin irritant on rabbits.
Under the test conditions, Aluminium sulphate is not classified as irritating to skin according to the Regulation (EC) N° 1272-2008 (CLP) and the GHS.
Reference
Table 7.3.1/1: Individual Skin Reactions
Skin Reaction |
Observation Time (following patch removal) |
Individual Scores – Rabbit Number and Sex |
||
145 Male |
146 Female |
148 Female |
||
Erythema/Eschar Formation |
Immediately |
0 |
0 |
0 |
1 h |
0 |
0 |
0 |
|
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
0.0 |
|
Oedema Formation |
Immediately |
0 |
0 |
0 |
1 h |
0 |
0 |
0 |
|
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0.0 |
0.0 |
0.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 5 to 29 March 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP guideline study well conducted.
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd.
- Age at study initiation: twelve to sixteen weeks old.
- Weight at study initiation: 2.73 Kg.
- Housing: suspended metal cage.
- Diet (e.g. ad libitum): Rabbit diet, Preston Farmers Limited.
- Water (e.g. ad libitum): drinking water.
- Acclimation period: five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 59-63%
- Air changes (per hr): 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light.
IN-LIFE DATES: no data. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- single application (the eyelids were gently held together for one second). The other eye, remaining untreated, serves as a control.
- Observation period (in vivo):
- 1, 24 and 48 hours following treatment.
- Number of animals or in vitro replicates:
- 1
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed
- Time after start of exposure: not applicable.
SCORING SYSTEM: Draize scale.
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation. Sloughing of the cornea was observed both at 24 and 48 hours.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation. White appearance of the nictitating membrane was observed both at 24 and 48 hours. Sloughing of the nictitating and conjunctival membranes were observed at 48 hours.
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- Mean individual score
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of severe irritation
- Remarks:
- The animal was sacrificed for humane reasons following the 48 hour period of observation
- Irritant / corrosive response data:
- - A dulling of the normal lustre of the corneal surface was noted one hour after treatment. Diffuse corneal opacity was noted at the 24 and 48-hour observations.
- Iridial inflammation was noted one hour after treatment and at the 24 and 48-hour observations;
- Moderate conjunctival irritation was noted one hour after treatment and at the 24 and 48-hour observations.
- Other adverse ocular effects noted were sloughing of the cornea at the 24 and 48 - hour observations, pale appearance of the nictitating membrane one hour after treatment, white appearance of the nictitating membrane at the 24 and 48- hour observations and sloughing of the nictitating and conjunctival membranes at the 48-hour observation. The animal was killed for humane reasons following the 48-hour observation. - Other effects:
- None.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Under the test conditions of this study, the test substance causes serious damage to eyes as corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed. Therefore, ALUM-17 (17% Al2O3) was classified in category 1 for eye damage according to Regulation (EC) N° 1272 -2008 (CLP) and to GHS.
- Executive summary:
In an eye irritation study performed similarly to the OECD test guideline No. 405 and according to GLP compliance, 0.1 g of ALUM-17 as powder was instilled into the conjunctival sac of one eye of only one female New Zealand rabbit. The other eye remained untreated served as control. Eyes were examined at 1, 24 and 48 hours following treatment and grading according to Draize scale.
A dulling of the normal lustre of the corneal surface was noted one hour after treatment following to a diffuse corneal opacity noted at 24 and 48-hours observations. Iridial inflammation and moderate conjunctival irritation were observed at 1, 24 and 48-hours observations. Other adverse effects included sloughing of the cornea up to 48 hours, pale appearance of the nictitating membrane one hour after treatment followed by white appearance of the nictitating membrane at 24 and 48-hour observations and sloughing of the nictitating and conjunctival membranes at 48-hours observation.The animal was sacrificed for humane reasons following the 48 hour period of observation.
Under the test conditions of this study, corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed and considered as serious ocular effects. Therefore, ALUM-17 was classified in category 1 for eye damage according to Regulation (EC) N° 1272 -2008 (CLP) and to GHS.
Reference
Table 7.3.2/1: Mean irritant/corrosive response data of one treated animal at each observation time up to removal from the test:
Anim. No. |
Effect |
Hours |
Days after application |
Mean score cornea Days 1/2 |
Mean score iritis Days 1/2
|
Mean score redness Days 1/2/3 |
Mean score chemosis Days 1/2/3 |
||
1 |
1 |
2 |
|
||||||
80 Female |
Cornea
Iris
Redness
Chemosis |
4 (d)
1
2 (Pa)
3 |
2 (sl)
1
2 (W)
3 |
2 (sl)
1
2 (SL W) 3 |
2
|
1 |
2 |
3 |
D : dulling of the normal lustre of the corneal surface
Sl : sloughing of the cornea
Pa : pale appearance of the nictitating membrane
W : white appearance of the nictitating membrane
SL : sloughing of the nictitating and conjunctival membranes
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
A key study was identified (Tuffnell, 1990). This study was performed according to OECD Guideline 404 and in compliance with GLP. Three rabbits were dermally exposed to 0.5 g of ALUM-17 as a powder (17% Al2O3) moistened with distilled water (0.5 mL) under a semi-occlusive dressing for 4 h. Skin irritation was scored by the method of Draize at 1, 24, 48 and 72 h after exposure.
No skin responses were noted during the study. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0, 0 for erythema and 0, 0, 0 for oedema score, respectively. Based on these results, Aluminum sulphate was considered to be non-irritant to skin.
Eye irritation:
A key study was identified (Dreher, 1990). This study was performed according to OECD Guideline 405 and in compliance with GLP. In this study, 0.1 g of ALUM-17 (17% Al2O3) as powder was instilled into the conjunctival sac of one eye of only one female New Zealand rabbit. The other eye remained untreated served as control. Eyes were examined at 1, 24 and 48 hours following treatment and grading according to Draize scale.
Corneal and conjunctival membrane sloughing and nictitating membrane whitening were observed and were not reversible. The animal was sacrificed for humane reasons following the 48 hour period of observation. Based on the results of this study, Aluminum sulphate was considered as corrosive to eyes.
Respiratory irritation:
No data available
Justification for selection of skin irritation / corrosion endpoint:
GLP Guideline study well conducted (Kr: 1). This study was identified as the key study because it was performed on Aluminum sulphate (purity: 99.98 % w/w as hydrated with 14H2O; corresponding/equivalent to 47-57 % w/w (typical purity : 52 % w/w) as anhydrous Al2(SO4)).
Justification for selection of eye irritation endpoint:
GLP Guideline study well conducted (Kr: 1). This study was identified as the key study because it was performed on Aluminum sulphate (purity: 99.98 % w/w as hydrated with 14H2O; corresponding/equivalent to 47-57 % w/w (typical purity : 52 % w/w) as anhydrous Al2(SO4)).
Effects on eye irritation: corrosive
Justification for classification or non-classification
Harmonized classification:
The substance has no harmonized classification according to the Regulation (EC) No. 1272/2008 (CLP).
Self classification:
Skin irritation/corrosion:
Based on the available data, the registered substance is not classified according to the Regulation (EC) No. 1272/2008 (CLP) and tu to GHS as all scores for both erythema and oedema are 0.
Eye irritation:
Based on the available data, the registered substance is classified into Category 1, H318 (causes serious eye damage) according to the Regulation (EC) No. 1272/2008 (CLP) and to the GHS as serious ocular effects were observed and were not reversible.
Respiratory irritation:
No classification is proposed due to lack of data.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)