2-tert-pentylcyclohexyl acetate

Endpoint summary

Description of key information

Acute rat oral toxicity in a similar to OECD TG 401 study: LD50 >= 5000 mg/kg bw

Acute rabbit dermal toxicity: similar to OECD TG 402: LD50 > 5000 mg/kg bw

Acute inhalation information using route to route extrapolation: LC50 > 13000 mg/m3

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is considered to be a reliability 2 study since it predates GLP but is similar to OECD TG 401.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

The study is considered to be a reliability 2 study since it predates GLP but is similar to OECD TG 402.

Additional information

Acute oral toxicity

Rat_Key: In a pre-GLP acute toxicity study similar to OECD 401, 10 rats were orally exposed to 5000 mg/kg bw test substance. All animals survived the 14 -day observation period. Under the conditions of the test the acute oral LD50 was determined to be >5000 mg/kg bw in rats.

Mice_Supporting: In a pre-GLP acute toxicity study similar to OECD 401, 10 mice per sex/dose were orally exposed to 3000, 4000, 6000, and 7000 mg/kg bw test substance. Animals were observed for 14 days and clinical signs were reported. After 14-days survivors were euthanized and necropsied and the gross pathology was reported. Mean body weights of male and female mice were increased after 14 days in all dose groups. Clinical signs were decreased activity, ataxia, salivation, urinary incontinence, and convulsions. 2/10, 5/10, 6/10 and 9/10 animals died after administration of 3000, 4000, 6000, and 7000 mg/kg bw test substance, respectively. Under the conditions of the test the LD50 was determined to be 4388 mg/kg bw with a 95% confidence interval of 1926 – 8564 mg/kg bw.

Rat_Additional, Summary information only: A recent acute oral toxicity study (2015) is available in the database of Research Institute for Fragrance Materials (RIFM). In an OECD TG 420 study the LD50 was found to be > 2000 mg/kg bw.

Acute inhalation toxicity

Using route to route extrapolation the inhalation toxicity can be derived as follows: an oral LD50 of > 5000 mg/kg bw can be roughly converted into > 13000 mg/m3 (CLP guidance, pg. 255, section, 3.1.3.3.3, 2015). The maximum saturated vapour pressure for the substance is (4.24 x 212,330 MW (mg/mol)) / (8.3 (R, gas constant) x 293 (°K)) = 370 mg/m3. This means that Coniferan cannot reach a concentration higher than 370 mg/m3. Therefore an LC50 for inhalation cannot be reached and no classification and labelling is needed for the acute inhalation route.

Acute dermal toxicity study

In a pre-GLP acute toxicity study similar to OECD 402, 10 rabbits were dermally exposed to 5000 mg/kg bw test substance. All animals survived the 14 -day observation period. Under the conditions of the test the dermal LD50 was determined to be >5000 mg/kg bw in rabbits.

Justification for classification or non-classification

Based on the results of the acute oral and dermal toxicity tests and the derived inhalation acute toxicity the substance does not have to be classified for acute toxicity in accordance with Regulation (EC) No. 1272/2008 and its updates.