Registration Dossier

Administrative data

Description of key information

non- skin sensitiser

Key value for chemical safety assessment

Skin sensitisation

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

Due to the absence of data on the Target substance, the assessment of skin sensitisation potential of the substance is done by taking into account data on Similar Substances. The justification for Read Across is given in Section 13 of IUCLID.

The key study [Huntsman Textile Effects (Germany) GmbH, 1995] on Similar Substance 01 was performed according to the modified Buehler Test following the OECD Guideline 406 under GLP conditions. Twenty male guinea pigs were treated topically with the test material at 50 % in bi-distilled water once a week for a three week induction phase. Two weeks after the final induction application the animals were challenged with the same test substance used for induction at a concentration of 50 % in bi-distilled water. The animals of the control group were not treated during the induction but were treated once at challenge with the test item at 50 % in bi-distilled water. Only two animals of the test group showed a slight confluent erythema at the first (24 h) and a slight, patchy erythema at the second reading (48 h). These findings were considered to be not significant. Therefore in this study, the test material was not found to be a dermal sensitizer.                

Further available data (attached) on other analogue substances confirm the non-sensitisation potential of the substance. Human studies (repeated insult patch test) also suggest that the substance is not sensitising to humans.

The key study is considered to be the most representative for the substance since it is conducted according to the OECD Guideline and under GLP conditions.

 

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, according to the CLP Regulation (EC) No. 1272/2008 the substance is not classified for skin sensitisation.