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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant studies were performed according to GLP and the methods applied are fully compliant with respective OECD Protocols (442C-E, 429). Given the inconclusive in vitro data, an in vivo study was performed. The in vivo study showed a dose dependent increas in SI increasing above 3 at a concentration of 50 % applied. Therefore, the read across results in a positive result for skin sensitisation. From the dose response the EC3 was extrapolated linearly to 38.81 %. See chapter 13 report for a more detailed justification.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant studies were performed according to GLP and the methods applied are fully compliant with respective OECD Protocols (442C-E, 429). See chapter 13 report for a more detailed justification.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Key result
Run / experiment:
other: 1
Parameter:
other: mean peptide depletion
Value:
1.54
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable because of methodological limitations
Remarks:
precipitation was observed
Key result
Run / experiment:
other: 1
Parameter:
other: luciferase activity
Value:
3.55
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of skin sensitisation
Remarks:
precipitation was observed
Key result
Run / experiment:
other: 1
Parameter:
other: CD86 upregulation in %
Value:
150
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Key result
Run / experiment:
other: 1
Parameter:
other: CD 54 upregulation in %
Value:
200
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of skin sensitisation
Key result
Parameter:
EC3
Value:
38.81
Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant studies were performed according to GLP and the methods applied are fully compliant with respective OECD Protocols (442C-E, 429). Given the inconclusive in vitro data, an in vivo study was performed. The in vivo study showed a dose dependent increas in SI increasing above 3 at a concentration of 50 % applied. Therefore, the read across results in a positive result for skin sensitisation. From the dose response the EC3 was extrapolated linearly to 38.81 %. See chapter 13 report for a more detailed justification.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The provided information shows a potential for Skin Sensitization. Therefore, the test item must be classified as for Skin Sensitisation Class 1B (H317) according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.