Phenol, 4,4'-(1-methylethylidene)bis-, oligomer with (chloromethyl)oxirane and ethylenediamine, reaction products with carbon disulphide, potassium salts

Endpoint summary

Description of key information

From consideration of the chemical structures, it is very likely that the substance is sensitising to the skin. Therefore, as it is considered that the current in-vitro methods are unsuitable for complex UVCB in the presence of solvent and in considering the requirement to avoid animal testing where possible, this assessment concludes that a classification as Skin Sens 1 is appropriate.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation, other

Remarks:

Assessment as positive

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

accepted calculation method

Justification for type of information:

Estimation as postive potential sensitisation based on chemical identity of key parts of the structure.
Substance contains bisphenol and thiocarbamate groups
Although this substance has not been directly tested in-vivo, this class of substance containing bisphenols and thiocaramates has been evaluated and is considered skin sensitising
The high molecular weight UVCB (in the presence of solvents) is not considered to be possible to test with reliability using current in-vitro method options.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Assessment based on chemical groups

Justification for non-LLNA method:

Assessment to avoid new animal testing

Specific details on test material used for the study:

The structure assessed will comprise of different oligomers and variants, but will all be of relatively high molecular weight and also all contain the thiocarbamate and bisphenol derivatives.

Species:

other: Source information predominantly guinea pig

Sex:

not specified

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

Remarks on result:

not measured/tested

From consideration of the chemical structures, it is very likely that the substance is sensitising to the skin. Therefore, as it is considered that the current in-vitro methods are unsuitable for complex UVCB in the presence of solvent and in considering the requirement to avoid animal testing where possible, this assessment concludes that a classification as Skin Sens 1 is appropriate.

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

From consideration of the chemical structures, it is very likely that the substance is sensitising to the skin. Therefore, as it is considered that the current in-vitro methods are unsuitable for complex UVCB in the presence of solvent and in considering the requirement to avoid animal testing where possible, this assessment concludes that a classification as Skin Sens 1 is appropriate.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)