Registration Dossier

Administrative data

Description of key information

The available data are not fulfilling the criteria for classification (H317) according to Regulation (EC) No 1272/2008

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No sensitisation was observed in a Repeated Insult Patch test (RIPT) with 200 subjects and in extensive tests with formulations containing the test substance in concentrations up to 16%. Several case reports are published which document allergic reactions in individuals, which had used cosmetics containing the test substance. Taking into consideration the broad application of the test substance in cosmetics and food, the potency of the substance for skin sensitisation is considered very weak.

There are no data on respiratory sensitisation available.

Key value for chemical safety assessment

Skin sensitisation

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

In a Repeated Insult Patch with 200 subjects a 50% solution of the test substance was applied 15 times (24 h each) within 5 weeks (exposures on Monday, Wednesday and Friday) by occlusive patch exposures at the upper arm. Two weeks later a challenge application was performed at the same site. No sensitisation was observed. The result of this study is supported by extensive tests with formulations containing the test substance in concentrations up to 16%, which also did not show skin sensitizing properties. Several case reports are published which document allergic reactions after use of cosmetic products containing the test substance. Taking into consideration the broad application of the test substance in cosmetics and food, the potency of the substance for skin sensitisation is considered very weak.

The data are not fulfilling the criteria for classification as skin sensitising agend according to Regulation (EC) No 1272/2008.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data and according to Regulation (EC) No 1272/2008 no classification for skin sensitisation is required. There are no data on respiratory sensitisation available.