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

Endpoint summary

Description of key information

Skin irritation (according to OECD404, GLP): not irritant

Eye irritation (according to OECD405, GLP): not irritant

Respiratory irritation (based on the non-irritant skin and eye properties): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Skin irritation: The ability of Cyclobutanate to induce skin irritation on New Zealand White rabbit skin was tested by topical application of Cyclobutanate for 4 hours followed by a 14 day observation period. The study was performed in accordance with OECD 404 guidelines and under GLP conditions. Rabbit skin, test site on the back of each rabbit, was treated by 4-hour semi-occluded application of 0.5 mL of Cyclobutanate followed by a 14 day observation period. Typical observation points were at 1, 24, 48, 72 hours and 7 and 14 days after the start of the application. Very slight erythema was noted at all treated skin sites one hour after patch removal with well-defined erythema at the 24-hour observation and very slight to well-defined erythema at the 48 and 72-hour observations. Slight edema was noted at one treated skin site and very slight edema was noted at two treated skin sites at the 24-hour observation. Very slight edema was noted at two treated skin sites at the 48 and 72-hour observations. It is concluded that Cyclobutanate is not considered to be irritant to rabbit skin under the experimental conditions of OECD TG 404.

Eye irritation: The ability of Cyclobutanate to induce eye irritation was studied in New Zealand White rabbit eyes in accordance with OECD 405 and EC Method B.5. The right eye of each rabbit was treated with 0.1 mL Cyclobutanate and the eyelids were held together for about one second immediately after treatment. This application was followed by a 72 hour observation period with typical observation points at 1 hour and 24, 48 and 72 hours. The left eye of each animal remained untreated and was used for control purposes. Eye irritation was scored according to the Draize classification. No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation at the 24-hour observation. All treated eyes appeared normal at the 48-hour observation. It is therefore concluded that Cyclobutanate is not considered to be irritant to rabbit eyes under the experimental conditions of OECD TG 405.

For respiratory irritation mostly human data are used for the assessment because no suitable in vitro or in vivo tests are available that can identify respiratory irritation (REACH guidance R.7.2.3). There are no human data such as indicated in R7.2.3 the ECHA guidance that indicate respiratory reactions of the substance e.g. from consumer experience or occupational exposure. The ECHA guidance presents (R7a: 7.2.12.1, 2017) that respiratory irritation maybe be indicated when the substance is a severe irritant. The substance is not a skin or eye irritant and therefore it is not likely to be a respiratory irritant

Justification for classification or non-classification

Cyclobutanate does not have to be classified as irritating to the skin or eyes and therefore also not for respiratory irritation, in accordance with EU CLP (EC no 1272/2008 and its amendments).