Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

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:
equivalent or similar to
Guideline:
OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ammonium sulfate
- Analytical purity: commercial grade
No further data

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 5-6 weeks
- Housing: individually housed in stainless-steel cages
- Acclimation period: at least 5 days

Administration / exposure

Type of coverage:
open
Vehicle:
other: water-acetone solution
Details on dermal exposure:
TEST SITE
- Area of exposure: back
- Procedure. 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.
Duration of exposure:
no data
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Applicant's summary and conclusion