Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well conducted study with limited detailed information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

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:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: obtained from sponsor, Material number 74-172
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: obtained from sponsor, Material number 74-172

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (Sex unspecified)
Control animals:
no
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: Clinical signs

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 reported
Gross pathology:
Not reported

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Based on CLP Criteria
Conclusions:
The oral LD50 value of Cedrenol in rats was established to be higher than 5000 mg/kg bw, under the conditions of this study. The substance therefore does not need to be classified for acute oral toxicity according to the criteria laid down in Annex I of 1272/2008/EC (CLP).
Executive summary:

The acute toxic potential of Cedrenol was assessed in an acute oral toxicity limit test performed in 10 rats. The rats were exposed to 5000mg/kg bw Cedrenol via the oral route, and observed for clinical signs and mortality over an examination period of 14 days. Daily observations were performed. At the end of the study period no mortality was observed in any of the animals. Furthermore no symptoms occured in the test animals. The LD50 for acute oral toxicity was therefore set at >5000 mg/kg bw. Based on these results Cedrenol does not have to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).