Registration Dossier
Registration Dossier
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EC number: 292-587-7 | CAS number: 90640-66-7
Endpoint summary
Administrative data
Description of key information
Only limited data are available for Amines, polyethylenepoly-, tetraethylenepentamine fraction. However, the registered substance is corrosive to skin and a strong base (pH >= 11.5). Therefore, no further testing is required.
Based on the harmonised classification of the main constituent of the registered substance the registered substance is also classified as Skin Sens. Cat. 1 (H317).
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There are only limited data available on skin sensitisation with Amines, polyethylenepoly-, tetraethylenepentamine fraction (CAS 90640-66-7). In order to fulfil the standard information requirements set out in Annex VII, 8.3., no further testing is required because the substance is classified as skin corrosion (Cat. 1B) and is a strong base (pH >= 11.5).
Two limited skin sensitisation studies (reliability 4) are available for the target substance Amines, polyethylenepoly-, tetraethylenepentamine fraction. Both studies on the registered substance are shortly described in publications. Both are GPMT tests (Leung, 1997; Thorgeirsson, 1978). In Leung (1997) no skin sensitisation potential was observed as only 5% of the animals showed a positive reaction after 5% intradermal induction. On the other hand, 73% guinea pigs showed positive response after 0.5% treatment with the target substance at intradermal induction (Thorgeirsson, 1978).
As both test cannot be used for classification due to limited documentation, no conclusion on classification can be drawn. However, the main constituent of the registered substance is tetraethylenpentamine (CAS 112 -57 -2) which is harmonised classified in Annex VI of Regulation (EC) No 1272/2008 as Skin Sens. Cat. 1 (H317). Therefore, the registered substance is also considered to be a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Only limited data with the registered substance on skin sensitisation are available which cannot be used for classification according to Regulation (EC) No. 1272/2008. The registered substance is skin corrosive (Cat. 1B) and a strong base (pH >= 11.5) therefore no further testing is warranted. However, the main consitutent ( tetraethylenepentamine, CAS 112 -57 -2) of the registered substance is harmonised classified in Annex VI of Regulation (EC) No 1272/2008 for skin sensitisation. Thus, the registered substance is also considered to be skin sensitising Cat. 1 (H317).
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