Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
; GLP was not compulsory at the time the study was conducted.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Methylanisole
- Analytical purity: no data given

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 - 3 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
TEST SITE
- Area of exposure: approx. 240 cm2
- Type of wrap if used: Cover was a sleeve and Webril padding
- Test site was clipped and left intact in half of the animals, while lightly abraded in the remaining animals
- Amount(s) applied: 5 ml/kg bw
Duration of exposure:
14 days
Doses:
5 ml/kg bw => 4850 mg/kg bw (calculated using density : 970 g/l)
No. of animals per sex per dose:
6 animals per dose (no further data)
Control animals:
not specified
Details on study design:
Toxic effects and mortality were recorded daily for 14 days
Pathology: gross necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 850 mg/kg bw
Remarks on result:
other: >5 ml/kg bw (calculation based on a density of 970 g/l)
Mortality:
No deaths occured, all animals survived.
Clinical signs:
Erythema score: 2-3 in 6/6 animals
Edema score: 1-3 in 5/6 animals
Scaling in 5/6 animals
Eschar in 3/6 animals

According to the authors, no other effects were seen.
Gross pathology:
According to the authors, no effects were seen.

Applicant's summary and conclusion