Registration Dossier
Registration Dossier
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EC number: 231-984-1 | CAS number: 7783-20-2
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:
- accepted calculation method
Data source
Reference
- Reference Type:
- publication
- Title:
- A simple method for screening assessment of acute toxicity of chemicals.
- Author:
- Yamanaka S et al.
- Year:
- 1 990
- Bibliographic source:
- Arch Toxicol 64:|262-268.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- open application
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Ammonium sulphate
- EC Number:
- 231-984-1
- EC Name:
- Ammonium sulphate
- Cas Number:
- 7783-20-2
- Molecular formula:
- H3N.1/2H2O4S
- IUPAC Name:
- diammonium sulfate
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
male and female Wistar rats
- Age at study initiation: 5-6 weeks
- Housing: individually housed in stainless-steel cages
- Acclimation period: at least 5 days
no further data
ENVIRONMENTAL CONDITIONS: no data
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: water-acetone solution (no further detail reported)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
Hair was first removed from an area of 3 x 4 cm² on the back of rats with an electric hair clipper, and then the chemical substances dissolved in acetone and water were applied in a single dose to the skin surface of the clipped backs of the animals. The application sites were not covered but the treated areas were prevented from being licked by using a plastic collar or by fixing the animals on a plastic plate.
REMOVAL OF TEST SUBSTANCE: no data - Duration of exposure:
- no data
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 males and 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical and behavioural abnormalities, body weight, mortality, gross lesions
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
Any other information on results incl. tables
Based on the results of this test, the LD50 was >2000 mg/kg bw.
Applicant's summary and conclusion
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