Registration Dossier

Administrative data

Description of key information

Ágh, 2010, assessed the corrosive potential of the registered substance using fully validated in vitro methods. This additional study was necessary due to the corrosive findings of Rowe et al, 1952. Rowe et al, 1952, reported only a 'simple' irritation to the rabbit ear, however when the substance was in contact with the skin on the belly of the animal a corrosive response was noted.
Ágh, 2010, reported a negative response for corrosivity in the in vitro test, however as a positive irritation response was noted by Rowe et al, 1952, it is considered that a weight of evidence approach between the two studies be used.
Rowe et al, 1952, also conducted an assessment of the eye irritation potential of the registered substance. Using a test method similar to the OECD 405 guideline irritation was noted in all test eyes, however, where the substance was washed out after application or where a high (>10%) concentration was applied a more severe reaction was noted.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Ágh, 2010, was conducted in order to assess the corrosive potential reported by Rowe et al, 1952, when the registered substance was placed in contact with the skin. The dermal absorption of the registered substance has been determined in other endpoints to be of high potential, however the corrosive potential noted by Rowe et al, 1952, was not observed in other endpoint studies. The in vitro method used was fully validated and suitable for the regulatory endpoint. Under the conditions of the test the registered substance produced a negative effect for corrosivity and based upon this new evidence the susbtance cannot be considered to be corrosive.

Rowe et al, 1952, provides information on both skin and eye irritation. Skin irritation was assessed by exposing the rabbit ear to a 1% solution of the registered substance in butyl carbitol acetate 10 times over 14 days in vivo. The registered substance caused only slight irritation to the rabbit ear, however then exposed to the skin on the belly of the animal the registered substance caused a severe burn and was absorbed through the skin.

Eye irritation was assessed in a similar manner to the OECD 405 guideline, however the registered substance was applied to both eyes, with a single eye being washed after 3 minutes. The registered substance caused more damage in eyes that were washed after 3 minutes of exposure than eyes that were not washed. It was therefore concluded that the registered substanceis not likely to cause permanent damage to the eye, however will cause pain and soreness for several days after exposure. Strong solutions (10% or more) may cause more serious injury than the undiluted material.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

The registered substance is currently classified as R36/37/38: Irritating to eyes, respiratory system and skin according to Annex I of 67/548/EEC and Eye Irrit. 2, STOT SE 3 and Skin Irrit 2 according to Annex VI of EC Regulation 1272/2008.

The information presented above supports this assessment therefore no changes to the classifications are proposed at this time.