Registration Dossier

Administrative data

Description of key information

Two irritation studies have been performed for BMS 296796-02; 1 key study for skin irritation and 1 key study for eye irritation.  All studies were assigned reliability rating of 1 (reliable without restriction).  The eye irritation study was conducted in 2001 according to OECD Method 405 and in accordance with GLP. The skin irritation study was conducted in 2002 according to OECD Method # 404 and in accordance with GLP. All results were considered valid. The test material is not irritating to skin but was moderating irritating to the eyes and is classified as an irritant according to EU labeling regulations.

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 study: The test material produced a primary irritation index of 0.0 and was classified as a non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. 

Eye irritation study: The maximum duration for both conjunctival redness and chemosis is 7 days and all treated eyes appeared normal at the 14-day observation. The test material produced an overall maximum group score of 32.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Studies were assigned reliability of 1 and followed acceptable OECD, EU or recognized standards and were in accordance with GLP.

Based on the results of the eye irritation study and according to EU labeling regulations the test material is classified as follows

According to 67/548/EEC (DSD) - an irritant assigned the symbol "Xi", the indication of danger " Irritant" and the risk phrase R36 "Irritating to the eyes."

According to Annex 1 to the CPL Regulation(GHS):

classification: eye irritation- category 2A,

symbol: exclamation mark

signal word: Warning

hazard statement "causes serious eye irritation"