Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Secondary source

Data source

Reference
Reference Type:
review article or handbook
Title:
Toxikologische Bewertung – p-Aminophenol.
Author:
Berufsgenossenschaft der chemischen Industrie BCI, Heidelberg, Germany
Year:
1995
Bibliographic source:
Toxicological Evaluation, 15, 337-381

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: tragacanth
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin (clipped hair)
TEST SITE
- Area of exposure: intact and abraded skin


TEST MATERIAL
- Concentration (if solution): 50% aqueous suspension with tragacanth
Duration of exposure:
24 hr
Doses:
2000. 4000 and 8000 mg/kg bw
No. of animals per sex per dose:
4 animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 8 000 mg/kg bw
Mortality:
All animals survived.
Clinical signs:
Deep green-brown discoloration of application site was observed, which later changed to yellowish-brown.
Gross pathology:
No. effect was observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU