Reaction products of N-(2-aminoethyl)ethane-1,2-diamine and methyl methacrylate and octane-1-thiol

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Remarks:

other: Assessment

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Estimated from starting materials and from analogue substances to be positive. Animal testing not considered justified.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Estimated from starting materials and from analogue substances to be positive. Animal testing not considered justified.

GLP compliance:

no

Type of study:

other: Assessment

The starting materials diethyltriamine, octylmercaptan and methylmethacrylate are classified as potential sensitisers and there is no reason to suspect that the oligomeric reaction products are any different. It is considered very likely that M2029 is itself a potential sensitiser and should be classified as such. 

 

Risk management measures should be put into place accordingly.

 

It is not considered appropriate to perform animal testing in view of the high level of certainty that a positive effect would be noted.

 

Assessments peformed on similar substances containing the same functional groups show that of the two alklythio-alcohols evaluated, the dodecylthio-propan-2-ol is considered a positive skin sensitiser, but the octylthio-ethanol tested negative in a maximised guinea pig study and a LLNA mouse study.

Interpretation of results:

sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The starting materials diethyltriamine, octylmercaptan and methylmethacrylate are classified as potential sensitisers and there is no reason to suspect that the oligomeric reaction products are any different. It is considered very likely that M2029 is itself a potential sensitiser and should be classified as such.

Risk management measures should be put into place accordingly.

It is not considered appropriate to perform animal testing in view of the high level of certainty that a positive effect would be noted.

Assessments peformed on similar substances containing the same functional groups show that of the two alklythio-alcohols evaluated, the dodecylthio-propan-2-ol is considered a positive skin sensitiser, but the octylthio-ethanol tested negative in a maximised guinea pig study and a LLNA mouse study.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

The starting materials diethyltriamine, octylmercaptan and methylmethacrylate are classified as potential sensitisers and there is no reason to suspect that the oligomeric reaction products are any different. It is considered very likely that M2029 is itself a potential sensitiser and should be classified as such. 

 

Risk management measures should be put into place accordingly.

 

It is not considered appropriate to perform animal testing in view of the high level of certainty that a positive effect would be noted.

 

Assessments peformed on similar substances containing the same functional groups show that of the two alklythio-alcohols evaluated, the dodecylthio-propan-2-ol is considered a positive skin sensitiser, but the octylthio-ethanol tested negative in a maximised guinea pig study and a LLNA mouse study.

Justification for selection of skin sensitisation endpoint:
Estimation based on structure and the properties of starting materials