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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The skin sensitising potential of the test article was assessed in a study conducted according to OECD guideline 406 (1981, GPMT, Ciba-Geigy Ltd 1984f). Induction was performed intradermally (1% in sesame oil) and one week later epicutaneously (10% in Vaseline, 48 h, occlusive). Two weeks after epidermal induction animals were challenged epicutaneously for 24 h with 1% test substance in Vaseline and Vaseline alone under semi-occlusive conditions. Under the experimental conditions employed, 70% (14/20) and 50% (10/20) of animals exhibited a positive skin reaction 24 and 48 hours after challenge, respectively.

Criteria for inclusion in GHS category 1A are a positive response in the GPMT in more than 60% of the guinea pigs at an intradermal induction dose of <= 1% .


Migrated from Short description of key information:
A valid study on skin sensitization with the test substance is available. In a study conducted according to OECD guideline 406 (GPMT) a positive skin reaction was observed in 14/20 animals after 24 h (guinea pig, Ciba-Geigy Ltd 1984f) and 10/20 animals after 48 h.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no 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 was classified for skin sensitization (Xi; R43) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC

(Annex I index no. 607 -176 -00 -3).

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. More than 60% of the animals showed a resonse at an intradermal induction dose of 1%. As a result the substance is considered to be classified for skin sensitization in Category 1A under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).

At the time the substance was included in table 3.1 of Annex VI (EC 1272/2008) no distinction was made between category 1A and 1B. The legal classification (Annex I index no. 607 -176 -00 -3)

is Skin Category 1 (H317).