Registration Dossier

Administrative data

Description of key information

Skin Irritation (Driscoll 1998): The test material is not considered to be an irritant under the conditions of the study.

Eye Irritation (Driscoll 1998): The test material can be considered to be an irritant based on the results of the study.

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:
adverse effect observed (irritating)

Additional information

Skin Irritation (Driscoll 1998)

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at two treated skin sites. All treated skin sites appeared normal at the 24-hour observation.

The test material did not meet the criteria necessary for classification as irritant or corrosive to the skin, according to EC labelling regulations.

Eye Irritation (Driscoll 1998)

A study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was based on that described in the OECD Guidelines for Testing of Chemicals (1987) No. 405 "Acute Eye Irritation/Corrosion" which essentially complies with Method B5 in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

A single application of 10 mg test material to the non-irrigated eye of one rabbit produced a moderate conjunctival reaction. The treated eye appeared normal at the 48-hour observation.

A single application of 0.1 mL (78 mg) test material to the non-irrigated eye of one rabbit produced a marked corneal, moderate iridial and moderate conjunctival reaction. Sloughing of the corneal membrane was also noted. The animal was killed immediately following the 24-hour observation due to the persistence of grade 4 corneal opacity for a 24-hour period with no evidence of recovery. This was in accordance with company policy and current UK Home Office guidelines.

The test material (10 mg Dose), produced a maximum total score of 12 in a single rabbit.

The test material (0.1 mL Dose), produced a maximum total score of 77 and was considered to present a very severe risk of eye damage (grade 5) to the rabbit eye according to the Draize classification scheme (based on one rabbit).

Conclusion

The test material was considered to be an irritant according to EC labelling regulations.

Effects on eye irritation: irritating

Justification for classification or non-classification

Although both studies were carried out on an analogue material, the analogue is considered to be sufficiently similar to the substance of interest (please see attached data matrix and justification in Section 13 for additional details) for it to be used for the purposes of health and environment risk assessments.

Skin Irritation (Driscoll 1998)

No corrosive effects were noted, furthermore the test material did not meet the criteria necessary for classification as irritant or corrosive to the skin, according to EC labelling regulations.

Eye Irritation (Driscoll 1998)

A single application of 0.1 mL (78 mg) test material to the non-irrigated eye of one rabbit produced a marked corneal, moderate iridial and moderate conjunctival reaction. Sloughing of the corneal membrane was also noted. The animal was killed immediately following the 24-hour observation due to the persistence of grade 4 corneal opacity for a 24-hour period with no evidence of recovery.

Based on the above information, the test material was considered to be an irritant according to EC labelling regulations.