Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

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:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
not specified
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5-3.0 kg
- Housing: Individually housed
- Diet: commercial diet
- Water: ad libitum

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 240 cm2
- % coverage: 10%
- Type of wrap if used: Rubber sleeve and Webril padding

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4900 mg/kg
- Constant volume or concentration used: yes/no
Duration of exposure:
24h
Doses:
4900 mg/kg bw
No. of animals per sex per dose:
6 (male/female)
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
Statistics:
no data

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 4 900 mg/kg bw
Based on:
test mat.
Mortality:
No deaths.
Clinical signs:
Edema (3 of 6 rabbits), Erythema (6/6), Dicoloration (-), Scaling (6/6), Necrosis (-) and Eschar formation (2/6)
Body weight:
No data
Gross pathology:
There was no tissue damage observed in rabbits killed at the termination of the study.
Other findings:
No data

Any other information on results incl. tables

The acute dermal LD50 value appear to be greater than 4900 mg/kg bw. No toxic signs were observed in rabbits receiving test material during the 14 -day observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Anethole is not classified according to Regulation (EC) No 1272/2008
Executive summary:

Anethole was screened for acute dermal toxicity in rabbits. Test material (4900 mg/kg bw) produced no deaths, it is assumed that the acute dermal LD50 value is above 4900 mg/kg bw in rabbits.