Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
- Principle of test: In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days.
GLP compliance:
no
Remarks:
pre GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
CAS 85085-41-2
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Cedarwood Virginia oil; Cedarwood oil Virginia or Virginia oil
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- No.of test material: Sample marking: 73-9

Test animals

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

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg bw
- Concentration (if solution): undiluted
Duration of exposure:
not specified
Doses:
Limit dose: 5000 mg/kg bw
No. of animals per sex per dose:
9
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations : daily
- Necropsy of survivors performed: not specified
- Other examinations performed: Skin irritation, others not specified

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Slight redness - 7/9
Moderate redness - 1/9
Slight edema - 3/9
Moderate edema - 6/9



Body weight:
not specified
Gross pathology:
not specified
Other findings:
not specified

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
based on CLP criteria
Conclusions:
The dermal LD50 of Cedarwood Virginia were determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Executive summary:

In this limit test, a high dose of 5000 mg.kg bw Cedarwood Virginia was applied dermally to the skin of 9 rabbits. The rabbits were observed for 14 days. No mortality was observed, and the LD50 was established to be higher than 5000 mg/kg bw. Based on the available information, the test substance does not need to be classified for acute dermal toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)