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

Skin sensitisation

Administrative data

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.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2015

Report date:

2015

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

(2-aminoethyl)(2-{[(2E)-3-methoxy-2-methyl-3-(octylsulfanyl)prop-2-en-1-yl]amino}ethyl)amine; 11-methoxy-12-methyl-3-(prop-1-en-2-yl)-2-oxa-4,7,10,14,17-pentaazanonadecan-19-amine; 2-methyl-3-(octylsulfanyl)-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; 3-({2-[(2-aminoethyl)amino]ethyl}amino)-2-methyl-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; N-{2-[(2-aminoethyl)amino]ethyl}-2-methyl-3-(octylsulfanyl)propanamide

EC Number:

929-305-5

IUPAC Name:

(2-aminoethyl)(2-{[(2E)-3-methoxy-2-methyl-3-(octylsulfanyl)prop-2-en-1-yl]amino}ethyl)amine; 11-methoxy-12-methyl-3-(prop-1-en-2-yl)-2-oxa-4,7,10,14,17-pentaazanonadecan-19-amine; 2-methyl-3-(octylsulfanyl)-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; 3-({2-[(2-aminoethyl)amino]ethyl}amino)-2-methyl-N-{2-[(2-{2-[(octylsulfanyl)methyl]propanamido}ethyl)amino]ethyl}propanamide; N-{2-[(2-aminoethyl)amino]ethyl}-2-methyl-3-(octylsulfanyl)propanamide

Results and discussion

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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.