Amines, (2-ethylhexyl)(hydrogenated tallow alkyl)methyl

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 26, 2016 to December 14, 20116

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA:J

Sex:

female

Vehicle:

propylene glycol

Concentration:

25%, 50%, 100%

No. of animals per dose:

5

Positive control results:

0.15% DNCB SI = 44.1
25% HCA SI = 22.0

Key result

Parameter:

EC3

Value:

3.1

Topical application of test article Amines (2-ethylhexyl)(hydrogenated tallow alkyl) methyl,

CAS No. 1078712-76-1, Lot/Batch No. TS 16013, at 25% and 50% (v/v) in propylene glycol, and at 100%

(neat), resulted in SI values greater than 3 (SI > 3), with minimal irritation. Therefore, this test article is a

dermal sensitizer in the Local Lymph Node Assay. Immunophenotyping results of all endpoints at all test

article concentrations exceeded 1.25-fold increases, indicating a positive sensitization response.

Interpretation of results:

Category 1B (indication of skin sensitising potential) based on GHS criteria

Conclusions:

Topical application of test article Amines (2-ethylhexyl)(hydrogenated tallow alkyl) methyl,
CAS No. 1078712-76-1, Lot/Batch No. TS 16013, at 25% and 50% (v/v) in propylene glycol, and at 100%
(neat), resulted in SI values greater than 3 (SI > 3), with minimal irritation. Therefore, this test article is a
dermal sensitizer in the Local Lymph Node Assay. Immunophenotyping results of all endpoints at all test
article concentrations exceeded 1.25-fold increases, indicating a positive sensitization response.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

This material is classified as a skin sensitizer based on the positive results observed in the LLNA; this includes a positive response observed with immunophenotyping. However, there is some uncertainty regarding whether this material is a skin sensitizer as there are no structural alerts (parents and metabolites predicted to be negative using OASIS Times modeling) and OECD Toolbox found three analogs that were all negative in the LLNA; these analogs have a smaller molecular weight than the target substance. Also, an M&K guinea pig study was negative for a larger molcuar weight analog.