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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Only limited data are available for Polyethylene polyamine, pentaethylenehexamine fraction. However, the substance is classified as corrosive therefore no further testing is required.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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.
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
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)
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
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
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
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

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

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

There are only limited data available on skin sensitisation with Polyethylene polyamine, pentaethylenehexamine fraction (PEHA). As the substance is classified as corrosive no further testing is required in order to fulfil the standard information requirements set out in Annex VII, 8.3 of Regulation (EC) No 1907/2006.

One supporting skin sensitisation study (reliability 4) is available for Polyethylene polyamine, pentaethylenehexamine fraction. The GPMT study on the registered substance is shortly described in a publication (Leung, 1997). Skin sensitisation potential was observed. 100% of the animals showed a positive reaction after 5% intradermal induction.

This result indicates a skin sensitising potential for PEHA. Furthermore, the linear PEHA (CAS 4067-16-7) which is the main constituent of PEHA is harmonised classified as skin sensitiser. Therefore, PEHA is also considered to be skin sensitising.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A harmonised classification for skin sensitisation the main constituent of PEHA - linear PEHA is available (Category 1, H317). Therefore, the substance meets the criteria for classification according to Regulation (EC) No. 1272/2008. Taking into account all data from animal and human studies no sub-categorisation is possible. The test substance is therefore classified as sensitising to skin Cat. 1 (H317).