Registration Dossier

Administrative data

Description of key information

Skin: The test item produced a primary irritation index of 4.0 and was considered to be a moderate irritant to rabbit skin according to the Draize scheme. However, the test material is not classified according to Regulation (EC) No 1272/2008 (CLP). No corrosive effects were noted. 
Eye: The test item produced a maximum group mean score of 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 (CLP).

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 study available

Additional information

SKIN IRRITATION

Skin irritation was assessed using a study designed to be compatible with OECD Guideline for the Testing of Chemicals No 404 "Acute Dermal Irritation/Corrosion (adopted 24 April 2002) and Method B.4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No 440/2008.

The test item produced a primary irritation index of 4.0 and was considered to be a moderate irritant to rabbit skin according to the Draize scheme. No corrosive effects were noted. However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 (CLP).

EYE IRRITATION

Eye irritation was assessed using a study designed to be compatible with OECD Guideline for the Testing of Chemicals No. 405 "Acute Eye Irritation/Corrosion" (adopted 02 October 2013) and Method B.5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008. A single application of the test item to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. Both treated eyes appeared normal at the 72 hour observation. The test item produced a maximum group mean score of 11.0 and was considered to be a mild irritant to the rabbit eye according to a modified Kay and Calandra system (Class 4 on a 1 to 8 scale). However, the test material is not classified under the terms of Regulation (EC) No 1272/2008 (CLP).


Justification for selection of skin irritation / corrosion endpoint:
GLP guideline study

Justification for selection of eye irritation endpoint:
GLP guideline study

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Skin: The test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for three animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for erythema and edema.

Eye: The test material is not classified under the terms of Regulation (EC) No 1272/2008 because the mean scores for two animals calculated using data from 24, 48 and 72 hour observations were below the stated limits for corneal opacity, iritis, conjunctival redness and chemosis.