Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401 (limit test) and was performed pre-GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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


TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
Not Specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Not Specified, sex not specified
Doses:
one limit dose of 5000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Necropsy of survivors performed: yes
- Other examinations performed: symptomatology

Results and discussion

Preliminary study:
Not relevant
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was noted
Clinical signs:
No effects observed
Body weight:
No data available
Gross pathology:
No effects mentioned
Other findings:
Not other effects were reported.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
based on CLP Regulation (1272/2008/EC).
Conclusions:
The oral LD50 value of Cedarwood Texas oilin rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study. The substance therefore does not need to be classified in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
Executive summary:

A single 5000 mg/kg bw dose of Cedarwood Texas oil was administered by oral gavage to 10 rats. The animals were observed for 14 days. No symptoms or mortality were noted. The oral LD50 value of

Cedarwood Texas oil in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.