Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

The substance caused no effects on rabbit skin upon 24h occlusive application (Ciba-Geigy Ltd. 1974a). It caused no indication of irritation upon instillation into the eyes of rabbits (Ciba-Geigy Ltd. 1974b). Both studies were performed prior to the introduction of GLP and similar to procedures outlined in current OECD testing guidelines.

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

The substance was tested for irritating properties prior to the introduction of OECD testing guidelines and GLP. Experimental procedures and reporting details are similar to current requirements, so both studies were assigned a validity score of 2 (valid with restrictions.)

The study for skin irritation followed a more stringent procedure as animals were exposed for 24h (Ciba-Geigy Ltd. 1974). Scoring was only done until the 72h reading and followed the Draize scoring system. Since no indication of erythema or edema were observed, the short observation period is an acceptable limitation.

The study design for the eye irritation is identical to OECD testing guideline 405, but less information on the animals and housing conditions are given. As no indication of irritation to cornea, iris or conjunctivae was observed, the observation period was terminated after the third day.

Both studies show that the substance is not irritating to skin and eyes.

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 fifth time in Directive EC 944/2013.