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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no adverse effect observed (not sensitising)
Additional information:

The key study for skin sensitisation (GPMT) was performed according to GLP and OECD guideline 406, using Himalayan White spotted guinea pigs (Klecak, 1989, B-154´682). For induction, the test substance (approx. 95% vitamin-A-palmitate) has been administered intradermally (5%) and topically (100%). For challenge and rechallenge, animals were treated dermally using a 30% dilution of the test substance. The substance-treated group showed positive dermal responses upon dermal challenge (4/20 animals after 24 hours, 2/20 animals after 48 hours). Challenge controls were found negative. Upon rechallenge, none of the animals in the treatment and control groups showed dermal reactions.


Migrated from Short description of key information:
A reliable skin sensitisation GLP guideline (OECD 406) study (GPMT) was performed in guinea pigs: 4/20 animals after 24 hours, 2/20 animals after 48 hours showed dermal reaction after challenge. No skin reactions were noted at challenge in control groups and at re-challenge in treatment/control groups.

Respiratory sensitisation

Endpoint conclusion
Additional information:

no data


Migrated from Short description of key information:
no data

Justification for classification or non-classification

The present data on dermal sensitization do not fulfill the criteria laid down in regulation 67/548/EEC and 1272/2008/EC, and therefore, a non-classification is warranted.