Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
- Principle of test: A single 5000 mg/kg bw dose of Cedarwood Virginia was administered by oral gavage to 10 male Wistar rats. The animals 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
- h No.of test material: Sample marking: 73-9

Test animals

Species:
rat
Strain:
Wistar
Sex:
not specified

Administration / exposure

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10
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: general symptomatology

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
None
Clinical signs:
slight lethargy
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 oral LD50 of Cedarwood Virginia was 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 oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).
Executive summary:

A single 5000 mg/kg bw dose of Cedarwood Virginia was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. Mortality was not noted. Slight lethargy was seen in animals dosed with the test material. The oral LD50 value of Cedarwood Virginia in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. Based on the available information, the test substance does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).