3,7-dimethylocta-1,3,6-triene

Endpoint summary

Description of key information

Acute oral toxicity of Ocimene: a study similar to OECD TG 401 was performed: LD50 = ca. 5000 mg/kg

Acute dermal toxicity of Ocimene: a study similar to OECD TG 402 was performed: LD50 > 5000 mg/kg

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:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Doses:

5.0 g/kg bw

No. of animals per sex per dose:

10 animals (sex unspecified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

ca. 5 000 mg/kg bw

Based on:

test mat.

Mortality:

5/10 animals died on day 1 of the observation period after exposure to 5.0 g/kg

Clinical signs:

None

Interpretation of results:

other: Not acutely harmful

Remarks:

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

Conclusions:

The acute oral toxicity test showed an LD50 of ca 5000 mg/kg bw. In accordance with GHS the substance needs to be labelled with H303: May be harmful.

Executive summary:

A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 5.0 g/kg bw. 5/10 animals died on day 1 of the 14 day observation period. No clinical signs were observed. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be ca 5000 mg/kg bw. Based on these results, the test substance is not considered to be acutely harmful.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

not specified

Vehicle:

not specified

Duration of exposure:

not specified

Doses:

5.0 g/kg bw

No. of animals per sex per dose:

7 animals (sex unspecified)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

1/7 animal died on day 7 of the observation period

Clinical signs:

- Anorexia in the animal which died
- Moderate redness and moderate edema was seen in all 7 animals.

Interpretation of results:

other: Not acutely harmful

Remarks:

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

Conclusions:

The acute dermal toxicity test showed an LD50 > 5000 mg/kg bw.

Executive summary:

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance.In this study 7 rabbits (sex unspecified) were administered with 5000 mg/kg test substance on the skin. 1/7 animals died on day 7 of the 14 day observation period after exposure to the test substance. Anorexia was observed in this animal and moderate redness and moderate edema was seen in all 7 animals. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was > 5000 mg/ kg bw. Based on these results, the test substance is not considered to be acutely harmful.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

The OECD TG 401 with Ocimene:

A pre-guideline study, equivalent to OECD guideline 401, was performed to identify the acute oral toxicity of the test substance. In this study 10 rats (sex unspecified) were administered with 5.0 g/kg bw. 5/10 animals died on day 1 of the 14 day observation period. No clinical signs were observed. Under the conditions of the test, the acute oral LD50 for the test substance in rat was determined to be ca 5000 mg/kg bw.

The OECD TG 402 with Ocimene:

A pre-guideline study, equivalent to OECD guideline 402, was performed to identify the acute dermal toxicity of the test substance.In this study 7 rabbits (sex unspecified) were administered with 5000 mg/kg test substance on the skin. 1/7 animals died on day 7 of the 14 day observation period after exposure to the test substance. Anorexia was observed in this animal and moderate redness and moderate edema was seen in all 7 animals. These local effects are used to support the absence of corrosion. Under the conditions of the test, the acute dermal LD50 for the substance in rabbits was > 5000 mg/ kg bw.

Justification for classification or non-classification

Based on the available information classification and labelling for acute oral and dermal toxicity is not warranted in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008 and its amendments.