Cedrus atlantica, ext.

Endpoint summary

Description of key information

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

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:

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. A concise description of the protocol is available and results are reported clearly.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: approximately 200 g
- Fasting period before study: 16-18 hrs
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

Route of administration:

oral: gavage

Vehicle:

not specified

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

10 males

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

Preliminary study:

Not relevant

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Mortality was not observed.

Clinical signs:

other: No effects observed

Gross pathology:

Necropsy performed: no effects detected

Other findings:

Not reported

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 value of Cedarwood Oil Atlas 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 according to the criteria laid down in Annex I of 1272/2008/EC (CLP).

Executive summary:

A single 5000 mg/kg bw dose of Cedarwood Oil Atlas was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No mortality or other symptoms were observed. The oral LD50 value for Cedarwood Oil Atlas in 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 for acute oral toxicity according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

The only study available in this dossier addressing this endpoint, is an older pre- GLP, and pre-OECD study, conducted according to methods similar to OECD guideline 401 (limit test) and it is considered appropriate to be used as the basis for the chemical safety assessment.

Additional information

Acute Oral Toxicity

A single 5000 mg/kg bw dose of Cedarwood Oil Atlas was administered by oral gavage to 10 male Wistar rats. The animals were observed for 14 days. No mortality or other symptoms were observed. The oral LD50 value for Cedarwood Oil Atlas in rats was established as exceeding 5000 mg/kg body weight, under the conditions of this study.

Justification for classification or non-classification

The oral LD50 of Cedarwood Atlas oil was determined to be higher than 5000 mg/kg bw. Based on the available information, the test substance is considered as non-toxic if swallowed and it does not need to be classified for acute oral toxicity, according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).