Amines, polyethylenepoly-, tetraethylenepentamine fraction

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

no data

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Remarks:

The study followed methods similar to OECD406. The study was not performed according to GLP. No data on test substance composition/purity. Results are described very limited, only a summary table is presented.

Data source

Reference

Reference Type:

publication

Title:

Evaluation of skin sensitization and cross-reaction of nine alkyleneamines in the guinea pig maximization test

Author:

Leung, H-W., Auletta, C.S.

Year:

1997

Bibliographic source:

J. Toxicol.-Cut. & Ocular Toxicol., 16(3), 189-195

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

GLP compliance:

no

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Test was performed before LLNA method has to be used as first choice.

Test material

Test material information

Constituent 1

Reference substance name:

Amines, polyethylenepoly-, tetraethylenepentamine fraction

EC Number:

292-587-7

EC Name:

Amines, polyethylenepoly-, tetraethylenepentamine fraction

Cas Number:

90640-66-7

Molecular formula:

C8H23N5, C10H25N5

IUPAC Name:

(2-aminoethyl)[2-({2-[(2-aminoethyl)amino]ethyl}amino)ethyl]amine; bis(2-aminoethyl)({2-[(2-aminoethyl)amino]ethyl})amine

Test material form:

liquid

Specific details on test material used for the study:

tetraethylenepentamine (TEPA, CAS No. 112-57-2),

Samples were obtained from the Union Carbide Corporation (South Charleston, WV).

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Study design: in vivo (non-LLNA)

Induction

Route:

intradermal and epicutaneous

Vehicle:

water

Concentration / amount:

intradermal: 5%
epicutaneous: 60%

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Challenge

Route:

epicutaneous, semiocclusive

Vehicle:

water

Concentration / amount:

50%

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

10 males and 10 females

Results and discussion

In vivo (non-LLNA)

Results

Group:

test chemical

Dose level:

intradermal induction: 5%; epicutaneous induction: 60%; challenge: 50%

Total no. in group:

18

Remarks on result:

no indication of skin sensitisation

Remarks:

5% showed positive reactions

Any other information on results incl. tables

Percentage of animals in the group showing a positive skin response: 5%. TEPA had low potency.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

From the results of this study is can be concluded that TEPA is not a skin sensitizer.

Executive summary:

A group of nine alkyleneamines were investigated for their potential to induce skin sensitization and to cross-react with one another to elicit a hypersensitivity response. Ethylenediamine was the most potent skin sensitizer, and diethylenetriamine was next in potency. The sensitizing potency was inversely correlated with the number of amine units. Cyclic amines such as piperazine had a lower sensitizing potency than the corresponding olefinic amines. Ethylenediamine also produced the strongest response in cross-reactions with other alkyleneamines. The results suggest that there was a direct correlation of the potencies to cause skin imtation, sensitization, and cross-sensitization in this family of alkyleneamines.