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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The registered substance is currently classified as sensitising to skin as a precaution.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 442C (In Chemico Skin Sensitisation: Direct Peptide Reactivity Assay (DPRA))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: OECD 422E (Dentritic Cell Line Activation: h-CLAT)
Deviations:
no
GLP compliance:
yes
Type of study:
other: Two out of three from Direct Peptide Reactivity Assay (DPRA), ARE-Nrf2 Luciferase test method and Dentritic Cell Line Activation (hCLAT)
Run / experiment:
other:
Remarks on result:
other: investigation is ongoing (the results of two concordant studies will determine the overall prediction)
Interpretation of results:
Category 1A (indication of significant skin sensitising potential) based on GHS criteria
Conclusions:
Investigation of skin sensitisation in vitro is ongoing. The results of two concordant studies will determine the overall prediction and, the substance is classified for skin sensitisation as a precaution until results become available. This decision was made because consideration of an analogue substance as a cosmetic ingredient concluded that sensitisation was likely following occupational exposure.
Executive summary:

Investigation of skin sensitisation in vitro is ongoing. The results of two concordant studies will determine the overall prediction and, the substance is classified for skin sensitisation as a precaution until results become available. This decision was made because consideration of an analogue substance as a cosmetic ingredient concluded that sensitisation was likely following occupational exposure.

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

Investigation of skin sensitisation in vitro is ongoing.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Investigation of skin sensitisation in vitro is ongoing and, in accordance with Regulation (EC) No. 1272/2008, classification of H317: Skin Sens 1 is considered to be necessary as a precaution. This decision was made because assessment of an analogue substance for use as a cosmetic ingredient concluded that sensitisation was likely following occupational exposure.