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Administrative data

Description of key information

Skin: not irritating (Non-GLP OECD Guideline Study 404, BASF, 85/48, 1985)
Eye: causes serious eye damage (Non-GLP OECD Guideline Study 405, BASF, 85/48, 1985)

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

There are valid in vivo data available for the assessment of the skin and eye irritation potential of 3 -chloro-toluidine.

Skin:

In a primary dermal irritation study (OECD 404, BASF, 85/48, 1985), 3 Vienna White rabbits (male and females) were dermally exposed to 0.5 mL of 3-chloro-o-toluidine for 4 hours under semiocclusive conditions. Animals then were observed for 3 days. Irritation was scored by the method of Draize as described in the OECD guideline 404. The mean score for the 24, 48 and 72 h reading for erythema was 0.6 and for edema was 0.1. The skin reactions observed were reversible until the end of the observation period on day 3. In this study, the test substance is not a dermal irritant.

 

Eye:

An eye irritation test was performed with three Vienna White rabbits (male and females) according to OECD 405 (BASF, 85/48, 1985). Eyes were left unwashed after application of 0.1 mL 3-chloro-o-toluidine and the animals were observed for 15 days. The mean score over the 24, 48 and 72 h readings was 1 for corneal opacity, 0 for iritis, 2 for conjunctivae redness and 1.3 for conjunctivae chemosis. In animal #1, loss of corneal tissue was noted 1 h after application. Suppuration was observed in animal #2 24 h after instillation. On day 15, loss of hair was noted for animal #1. Marginal vascularization of the cornea was seen in animal #1 and 2 on day 8 and in animal #2 on day 15. Moreover, small retractions in the eyelids were noted in all animals an day 8 and in animals #2 and 3 on day 15. As outlined in the raw data, slight opacity covered the complete corneal surface in all animals throughout the study period. The reversibility of these finding until day 21 is doubtful. Therefore, this substance is classified as causing serious damage to the eyes.

Effects on eye irritation: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin irritation but is considered to be classified for eye irritation (R41) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, 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 irritation but is considered to be classified for eye irritation (Category 1) under Regulation (EC) No. 1272/2008.