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
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.
