Octadecane-1,12-diol

Endpoint summary

Description of key information

Acute toxicity data indicate no acute toxicity. In rats the oral LD50 was >5000 mg/kg bw (similar to OECD 401). Dermal exposure in rats resulted in a LD50>2000 mg/kg/bw (OECD 402, GLP compliant).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

An acute oral toxicity test was conducted similar to OECD 401 by oral gavage. 10 male Wistar rats per dose were exposed to a single dose of 1000 or 5000 mg/kg test substance suspended in 2 % aqueous CMC-suspension. The rats were observed for 14 days. None of the 20 animals died during the period of 14 days after application and no symptoms of intoxication were observed. Under the conditions of this study the median lethal dose (LD50) of the test substance after oral application was found to be greater than 5000 mg/kg bw in male rats.

An acute dermal toxicity test was conducted according to OECD 402 and compliant with GLP. 5 male and 5 female Wistar rats were exposed for 24 hours to a single dose of 2000 mg/kg bw test substance suspended in corn oil. On the dorsal and dorsolateral parts of the trunk an area of 40 cm2 (at least 10% of the body surface) was clipped and exposed to the test substance under semi-occlusive conditions. After 24 hours the application site was rinsed with warm water and animals were observed for 14 days. No mortality, systemic clinical effects, local skin effects and macroscopic pathologic abnormalities were observed. The mean body weight of the animals increased within the normal range throughout the study period with one exception in the female group however this stagnation is considered to be unspecific. Under the conditions of this study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.

Justification for selection of acute toxicity – oral endpoint
Non-GLP, near guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

Justification for selection of acute toxicity – dermal endpoint
GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Justification for classification or non-classification

Based on the results of the acute oral and dermal studies, the substance does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.