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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.