Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Test was conducted according to methods similar to OECD guideline 402 (limit test) and was performed pre-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
Limit test
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
Details on test material:
CAS 91722-61-1
For specific details on test material if available - See in RSS
Name of test material (as cited in study report or in reference): Cedarwood Texas oil
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Batch No.of test material: EOA 75-12

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
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

Duration of exposure:
24h
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 animals per dose, sex not specified
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily

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:
none
Body weight:
not specified
Gross pathology:
no effects reported
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
Based on the CLP Regulation (1272/2008/EC).
Conclusions:
The dermal LD50 value of Cedarwood Texas Oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified according to the classification criteria outlined in annex 1 of CLP Regulation 1272/2008/EC (CLP).
Executive summary:

10 Rabbits were dermally exposed to 5000 mg/kg bw dose of Cedarwood Texas Oil. The animals were observed for 14 days. No symptoms or mortality were noted. The dermal LD50 value of Cedarwood Texas Oil in rabbits was established as exceeding 5000 mg/kg body weight, under the conditions of this study.