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Toxicological information

Acute Toxicity: dermal

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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:
1990
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

Constituent 1
Chemical structure
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:
Monochloramine generated from ammonium sulphate and a chlorine source
Test material form:
solid: crystalline

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