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Diss Factsheets

Toxicological information

Skin sensitisation

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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)
Deviations:
yes
Remarks:
insufficient documented
GLP compliance:
no
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
Polyethylene polyamine, pentaethylenehexamine fraction
EC Number:
701-266-7
Molecular formula:
Complex UVCB substance
IUPAC Name:
Polyethylene polyamine, pentaethylenehexamine fraction
Test material form:
liquid
Specific details on test material used for the study:
Name in the publication: pentaethylenehexamine (PEHA, CAS 4067-16-7)
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: 100%
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
water
Concentration / amount:
100%
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:
100%
No. with + reactions:
19
Total no. in group:
19
Remarks on result:
positive indication of skin sensitisation
Remarks:
100% positive

Any other information on results incl. tables

Percentage of animals in the group showing a positive skin response: 100% PEHA had low potency.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS Category 1 (H317) according to Regulation (EC) No 1272/2008
Conclusions:
From the results of this study is can be concluded that the test substance is 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 irrtation, sensitization, and cross-sensitization in this family of alkyleneamines.