Butanoic acid, 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl ester

Endpoint summary

Description of key information

Acute oral toxicity (according to OECD423, GLP): LD50 > 5000 mg/kg bw

Acute dermal toxicity (according to OECD402, GLP): LD50 > 2000 mg/kg bw

Acute inhalation toxicity (using route to route calculation): LD50 > 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 selected study is the key (and only) study and is adequate to cover this endpoint.

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

Additional information

Acute toxicity via oral route: In an acute oral toxicity study (according to the acute toxic class method), three males and three females were administered 2000 mg/kg bw Cyclobutanate by gavage. No mortality was observed. Clinical observations were hunched posture in all females, ataxia and lethargy in one female. No signs of systemic toxicity were noted in males. No abnormalities were noted at necropsy. The acute oral median lethal dose was estimated at >5000 mg/kg bw based on the scheme of the updated OECD TG 423 (2001).

Acute toxicity via dermal route: An acute dermal toxicity test (limit test) was performed with Cyclobutanate as testing material. The test was performed according to OECD guideline 402 (Acute dermal toxicity) in a group of 10 rats (5 males, 5 females). The rats were dermally exposed to the substance at 2000 mg/kg bw for 24 hours. The substance was applied to a shorn skin (approximately 10% of body surface) using a graduated syringe. A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage. No mortality was observed in the 14 days period after exposure. No signs of systemic toxicity were observed during clinical observation. No signs of dermal irritation were noted in male animals. Very slight erythema was noted in all female animals one to three days after dosing. No abnormalities were noted at necropsy. Body weight of all animals increased during study. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat, was found to be >2000 mg/kg bw.

Acute toxicity via vapour: The oral LD50 of >5000 mg/kg bw can be roughly converted into mg/m3 with the following equation: 1 mg/kg bw = 0.0052 mg/l/4h (ECHA guidance on CLP, 2017). For conservative reasons the inhalation absorption is set at 100% and orally at 50%. This results in > 13000 mg/m3. With a maximum SVC of 1013 mg/m3 the inhalation LC50 cannot be reached.

Justification for classification or non-classification

Based on the oral LD50 > 5000 and the dermal LD50 > 2000 mg/kg bw in rats and the calculated inhalation LC50 > 13000 mg/m3, Cyclobutanate does not have to be classified as acute toxic, in accordance with EU CLP (EC no 1272/2008 and its amendments).