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Administrative data

Description of key information

The substance was not irritating upon 24h exposure to rabbit skin (CIBA-GEIGY 1976c). It caused slight transient effects on rabbit eye (CIBA-GEIGY 1976g).

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 was assessed in a study in rabbits following the procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO) (CIBA-GEIGY 1976c). This procedure is more stringent than OECD testing guideline 405, as it requires 24h occlusive exposure. Observations were made only at the 24h and 72h time point. This is acceptable because no indication of erythema and edema were observed. Absence of skin irritation was also observed during the acute dermal toxicity study. 

 

Eye irritation was assessed in a study in rabbits following a procedure equivalent to OECD testing guideline 405 (CIBA-GEIGY 1976g). Animals were observed for 7 days. Scoring is based on the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO) For cornea of unwashed eyes, only one animal showed after 24 hours a score of 1, which was not seen after 48 hours anymore.

For conjunctivae of unwashed eyes, only one animal showed conjunctival irritation until 72 hours after treatment. The other two animals as well as animals with washed eyes did not show any irritation.

 

Both studies were performed prior to the introduction of GLP, but sufficient details on procedure and results are given.


Justification for selection of skin irritation / corrosion endpoint:
Only study available

Justification for selection of eye irritation endpoint:
Only study available

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 or eye irritation 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 or eye irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive EC 286/2011.

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