Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

One study was recorded for this endpoint. The study of Manciaux (1998) was reliable without restrictions and was identified as a key study.

In this study, the potential of the substance to induce delayed contact hypersensitivity was assessed in guinea pigs accordingto the OECD (n°406, 17th july 1992) and Commission Regulation (EC) (n°96/54/E.E.C., B.6, 30 july 1996) guidelines. The study was performed in compliance with the principle of Good Laboratory Practices regulations.

Thirty guinea pigs were allocated to two groups: a control group of five males and five females and a treated group of ten males and ten females. The induction phase was realized both by intradermal route on day 1 (Test material 0.1 % w/w in 0.9% NaCl) and by cutaneous route on day 8 (Test material 10% w/w in 0.9% NaCl). The challenge phase was realized on day 22 by cutaneous application of the test material at 1% w/w in 0.9% NaCl. The cutaneous reactions were scored 24 and 48 after the challenge phase.

No clinical signs and no deaths related to treatment were noted during the study. After the challenge application, no cutaneous reactions were observed in the treated animals nor in the control group.

The animals treated with positive control showed a satisfactory sensitisation response of 90% for 2,4-Dinitrochlorobenzene and 30% for mercaptobenzothiazole.

According to the Magnusson & Kligman maximization method,the test substance does not induce delayed contact hypersensitivity in guinea pigs.


Migrated from Short description of key information:
The potential of the substance to induce delayed contact hypersensitivity was investigated using the Maximization method of Magnusson and Kligman(OECD 406, GLP) . The test item was found to be non-sensitising (Manciaux, 1998)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No information on the sensitising potential of the substance via the inhalation route is available. As Polyram SL is not considered as a sensitizer via the dermal route the risk that the substance is a respiratory sensitizer is regarded as negligible.


Migrated from Short description of key information:
- No information on the sensitising potential of the substance via the inhalation route is available.

Justification for classification or non-classification

Skin sensitisation:

According to the results of the guinea-pig maximization test and the criteria laid down in EU regulation (EC) n°1272/2008 (CLP) and EU Directive 67/548/EEC, the substance is not classified for skin sensitisation.

Respiratory sensitisation:

No information on the sensitising potential of the substance via the inhalation route is available. As the substance is not considered as a sensitizer via the dermal route the risk that the substance is a respiratory sensitizer is regarded as negligible. Based on this reasoning the substance does not need to be classified for respiratory sensitization according tothe criteria laid down in EU regulation (EC) n°1272/2008 (CLP) and EU Directive 67/548/EEC.