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

Skin sensitisation

Administrative data

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.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

600-775-0

Cas Number:

1067676-04-3

IUPAC Name:

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

Test material form:

liquid

Details on test material:

Technical grade, CA 50% in water

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.

In vivo test system

Test animals

Species:

other: Source information predominantly guinea pig

Sex:

not specified

Results and discussion

In vitro / in chemico

Results

Remarks on result:

not measured/tested

In vivo (non-LLNA)

Results

Remarks on result:

not measured/tested

In vivo (LLNA)

Results

Remarks on result:

not measured/tested

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.