Cedrus deodara, ext.

Acute Toxicity: oral

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: read across

Justification for type of information:

The read across justification is presented in the endpoint summary and the accompanying files are also attached there.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Interpretation of results:

other: not acute toxic

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

Based on the results of the study for read-across substance Cedarwood Texas oil distilled, Cedarwood oil Himalayan is considered to be not acute toxic via the oral route.

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-GLP

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octahydro-3,8,8-trimethyl-6-methylene-1H-3a,7-methanoazulen-5-ol

EC Number:

248-917-7

EC Name:

Octahydro-3,8,8-trimethyl-6-methylene-1H-3a,7-methanoazulen-5-ol

Cas Number:

28231-03-0

Molecular formula:

C15H24O

IUPAC Name:

Cedr-8(15)-en-9-ol

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:

other: None

Gross pathology:

Not reported

Applicant's summary and conclusion

Interpretation of results:

other: Not acute toxic

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

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.

Executive summary:

The acute toxic potential of Cedrenol was assessed in an acute oral toxicity limit test performed similar to OECD TG 401. Ten 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. Based on these results the LD50 for acute oral toxicity was set at > 5000 mg/kg bw.