Essential oil of Cedarwood Texas obtained from the wood of Juniperus mexicana (Cupressaceae) by distillation - Cedrol

Endpoint summary

Description of key information

Acute oral toxicity (similar to OECD TG 401): LD50 >5000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

Limit test:

yes

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

Species:

rat

Strain:

not specified

Sex:

not specified

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

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

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).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

Well conducted study with limited detailed information

Additional information

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.

Justification for classification or non-classification

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 in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).