Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No data is available on sensitisation the test substance. However, reliable data from a skin sensitisation study performed with CAS 16470-24-9; a close structural analogue, is available.

Potential for skin sensitisation has been investigated for in a guinea pig maximisation assay according to OECD TG 406 with CAS 16470-24-9 (88.1% pure). 20 Pirbright White Strain (Tif: DHP) per group were intradermally (1% test substance in physiological saline and adjuvant mixture) and epidermally (30% test substance in Vaseline, 48 h, occlusive) induced. The control animals were treated with adjuvant/vehicle only. One week after the epidermal induction, challenge was performed with 10% test substance in Vaseline (24 h, occlusive) and scoring was done 24 and 48 h after patch removal. 0/20 animals of the test group and 0/20 animals of the negative control group showed positive reactions. No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred. Paraphenylene-diamine or Potassium-dichromate was used as positive control (data not presented). From the result described no allergenic potential of the test substance were concluded. Thus, the test substance is not considered sensitising and classification is not warranted (CIBA-GEIGY Ltd., 1987).

Supporting data from a human patch test with CAS 16470-24-9 is available. 102 females were repeatedly (11 applications) treated with the test substance (1%) and skin reactions were recorded to evaluate the irritating as well as the sensitising potential of the test substance. No effects were observed (Bayer AG, 1973).


Migrated from Short description of key information:
Skin sensitisation (OECD 406; GPMT): not sensitising; RA from CAS 16470-24-9

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation is reliable and suitable for classification. Based on this data, classification for skin sensitisation according to 67/584/EEC and EC/1272/2008 is not warranted.