Registration Dossier

Administrative data

Description of key information

2-(2H-benzotriazol-2-yl)-4-methylphenol caused temporary mild conjunctival reactions in two of six rabbits animals in a study following the design of OECD testing guideline 405 (Davies 1972). Occlusive application of 1000 mg onto shaved rat skin for 24h did not cause local signs as assessed by Draize scores (Thomann 1972). The substance is therefore considered to be non irritating to skin and to eyes. Experimental data on respiratory irritation is not available.

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

2-(2H-benzotriazol-2-yl)-4-methylphenol caused temporary mild conjunctival reactions in two of six rabbits animals in a study following the design of OECD testing guideline 405 (Davies 1972). Based on the results, no classification for eye irritation is required. This is study is sufficiently well described to serve as key study, although it lacks reporting details on body weight and housing conditions. A secondary source states that 2-(2H-benzotriazol-2-yl)-4-methylphenol has “irritating” properties (Marhold 1972). In the absence of further information such as method and scoring criteria, this information cannot be used for hazard assessment.

 

2-(2H-benzotriazol-2-yl)-4-methylphenol caused no signs of skin irritation in a combined study for skin irritation and acute dermal toxicity with a limit dose of 1000 mg/kg bw that after occlusive application onto shaved rat skin as an aqueous paste for 24h (Thomann 1972). Scoring was based on the Draize scores and reported to have been done during eight days after application. No individual scores are given, it is stated that for all endpoints, animals showed neither symptoms nor local changes. The study was performed prior to the introduction of GLP. The exposure conditions are more stringent than the 4h semiocclusive application required in OECD testing guideline 404. The study is considered to contain sufficient detail to allow classification and labelling and to serve as key study.

In the skin sensitization study (Hagemann 1992), occlusive application of vaseline paste containing 20% of the test substance (40 mg test item on 2 cm2guinea pig skin) for 24h caused mild erythema findings in one of ten challenge control animals at the 24h and in two of 10 animals at the 48h reading.

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No. 1272/2008.