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EC number: 232-055-3 | CAS number: 7784-25-0
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2002-09-18 to 2003-03-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed accordingly to the OECD Guideline No. 402 and in compliance with the GLP. Moreover, the information on the test substance is available.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Aluminium ammonium bis(sulphate)
- EC Number:
- 232-055-3
- EC Name:
- Aluminium ammonium bis(sulphate)
- Cas Number:
- 7784-25-0
- Molecular formula:
- Al.H3N.2H2O4S
- IUPAC Name:
- aluminium ammonium bis(sulphate)
- Details on test material:
- - Name of test material (as cited in study report): Curb Powder, Aluminium ammonium sulfate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeding Facility, Jai Research Foundation, India
- Age at study initiation: 10 weeks old at the time of dosing
- Weight at study initiation: 235 to 289 g
- Fasting period before study: No data
- Housing: 3 animals per cage in polypropylene cages covered with stainless steel grid top. Autoclaved clean rice husk was used as the bedding material.
- Diet (e.g. ad libitum): ad libitum; rat pellet diet (Amrut brand) manufactured by Pranav Agro Industries Limited, Pune, Mahashtra, India
- Water (e.g. ad libitum): ad libitum in a polypropylene water bottle with a stainless steel nozzle. The drinking water was filtered through Aquagard water filter system.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 25 °C
- Humidity (%): 67%
- Air changes (per hr): 18 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h artificial light / 12 h darkness
IN-LIFE DATES: From 2002-10-26 to 2002-11-15
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Remarks:
- distilled
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Hair were closely clipped from the dorsal area of the trunk of each animal, 24 hours prior to treatment.
- % coverage: 10% of the body surface area
- Type of wrap if used: porous gauze dressing and Medi tape 330 hypo-allergic surgical tape (manufactured by JMS Co. Ltd., Hiroshima 730, Japan).
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, residual test substance was remove using cotton moistened with distilled water.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The quantities of Aluminium ammonium sulfate powder moistened with distilled water were calculated for each animals
- Concentration (if solution): no data
- Constant volume or concentration used: no
- For solids, paste formed: not applicable
VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): no data
- Lot/batch no. (if required): not required
- Purity: no data - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg / kg bw
- No. of animals per sex per dose:
- See table 7.2.3/1
Two groups: 0 mg / kg bw (control group) and 2000 mg / kg bw
Five males and five females per group - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at 1, 2, 3 and 5 hours after the treatment, and then daily for 14 days. Individual body weights were recorded prior the treatment (day 0) and on days 7 and 14 after treatment.
- Necropsy of survivors performed: yes, gross pathological examination (external examination and internal examination of abdominal and thoracic cavities).
- Other examinations performed: clinical signs, body weight - Statistics:
- No data
Results and discussion
- Preliminary study:
- A dose range-finding study for Aluminium ammonium sulfate powder was performed using four animals ( 2males and 2 females) per group at dose levels of 2000 and 2500 mg / kg bw. No mortality was observed neither at 2000 mg / kg bw nor at 2500 mg / kg bw. Therefore, the main study was conducted as a limit study at the dos level of 2000 mg / kg bw.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed in the control group as well as the group treated with Aluminium ammonium sulfate at the dose level of 2000 mg / kg bw.
- Clinical signs:
- other: No clinical signs were observed in the control group as well as the treated group.
- Gross pathology:
- External examination of animals belonging to the control and the treatment groups did not reveal any abnormality or lesion of pathological significance.
Internal examination of animals belonging to the control and the treatment groups revealed lesions in lungs (haemorrhage, consolidation / hepatisation / pneumonic foci); spleen (enlarge) and kidneys (congestion).
The above recorded lesions were unrelated with the test substance and could be considered as spontaneous / incidental findings. - Other findings:
- No additional findings
Any other information on results incl. tables
Table 7.2.3/2: Group mean body weight
Group |
Dose of Aluminium ammonium sulfate (mg / kg bw) |
Sex |
Mean Body Weights (g) |
Mean Per cent Body Weight Change |
|||
day 0 |
day 7 |
day 14 |
day 7 |
day 14 |
|||
I |
0 (Control) |
5 males |
267 ±14 |
299 ± 13 |
332 ± 15 |
12.0 ± 1.7 |
24.6 ± 3.7 |
5 females |
242 ± 4 |
247 ± 6 |
258 ± 6 |
2.2 ± 2.9 |
6.7 ± 1.9 |
||
II |
2000 |
5 males |
271 ± 11 |
293 ± 12 |
327 ± 11 |
8.0 ± 0.6 |
20.6 ± 3.5 |
5 females |
243 ± 5 |
250 ± 7 |
258 ± 12 |
3.0 ± 1.3 |
6.4 ± 3.9 |
Values are mean ± standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, aluminium ammonium sulfate is not classified according to the criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.
- Executive summary:
In an acute dermal toxicity study, Aluminium ammonium sulfate was applied by dermal way to 10 males and females Wistar rats at dose levels of 0 (negative control) and 2000 mg/kg bw. This study was performed in compliance with Good Laboratory Practices and according to OECD Guideline 402 (Acute Dermal Toxicity).
A range-finding study was preliminary performed to determine the limit dose for the main study. Therefore, the main study was conducted as a limit study at the dos level of 2000 mg / kg bw.
The rats were observed for mortality and overt signs of toxicity at 1, 2, 3 and 5 hours after the test substance application. Subsequently, the animals were observed for a period of 14 days following dermal application. Individual body weights were recorded prior to dermal application (day 0) and on days 7 and 14 following dermal application. At the end of the 14 days observation period, all the animals were euthanised and subjected to gross pathological examination.
No clinical signs, no significant changes in the body weight and no mortality were observed in the treated group (2000 mg / kg bw) in comparaison with the control group. The external and internal examinations revealed no abnormality due to the test substance.
The acute dermal lethal dose (LD50) of aluminium ammonium sulfate in rats is higher than 2000 mg / kg bw.
Under the test conditions, aluminium ammonium sulfate is not classified according to criteria of the Annex VI to the CLP Regulation and to the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.
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