Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

No studies are available for hydroxyethylpiperazine mixture. Studies concerning skin sensitisation are available for the single components of the mixture (piperazine CAS 110-85-0 and 2-piperazin-1-ylethanol CAS 103-76-4).

In a guinea pig maximisation test according to Magnusson-Kligmann (Leung, 1997, CAS 110-85-0 and CAS 103-76-4), groups of 10 male and 10 female guinea pigs received intradermal, of 0,1 mL 5% piperazine or 2-piperazin-1-ylethanol solution and epicutaneous induction of 50% solution of piperazine or 100% of 2-piperazin-1-ylethanol, for 48 h respectively. Epicutaneous challenge was undertaken after 14 days with either 25% of piperazine or 100% of 2-piperazin-1-ylethanol. 5% of the animals treated with piperazine and 10% of the animals treated with 2-piperazin-1-ylethanol showed signs of sensitization. These results lead to the conclusion that piperazine and 2-piperazin-1-ylethanol have a weak sensitising potential.

Skin sensitisation have been noted among humans and worker exposed to piperazine (CAS 110 -85 -0).

Since these effects are known for piperazine and piperazine is a constituent of about 15% in hydroxethylpiperazine mixture it is assumed that hydroxethylpiperazine mixture will also show skin sensitising properties.

Migrated from Short description of key information:
No studies are available for hydroxyethylpiperazine mixture. Studies concerning skin sensitisation are available from two of the three single components of the mixture (piperazine CAS 110-85-0 and 2-piperazin-1-ylethanol CAS 103-76-4).
GPMT: not sensitising (Leung, 1997, CAS 110-85-0 and CAS 103-76-4)
Skin sensitisation in humans: sensitising (EU risk assessment of piperazine (CAS 110-85-0), 2005)

Respiratory sensitisation

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

No studies are available for hydroxyethylpiperazine mixture. Occupational observations concerning respiratory sensitisation in humans are available for one constituent of the mixture (piperazine CAS 110-85-0). Respiratory sensitisations have been noted among workers exposed to piperazine.

Since these effects are known for piperazine and piperazine is a constituent of about 15% in hydroxethylpiperazine mixture it is assumed that hydroxethylpiperazine mixture will also show respiratory sensitisation properties.

Migrated from Short description of key information:
No studies are available for hydroxyethylpiperazine mixture. Occupational observations concerning respiratory sensitisation in humans are available for one constituent of the mixture (piperazine CAS 110-85-0).
Respiratory sensitisation in humans: sensitising (EU risk assessment of piperazine (CAS 110-85-0), 2005)

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified for skin (R43) and respiratory sensitisation (R42) under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for skin (Cat. 1) and respiratory sensitisation (Cat. 1) under Regulation (EC) No. 1272/2008.