Registration Dossier

Administrative data

Description of key information

Not sensitising (OECD 406, GLP, K, rel. 1)

Key value for chemical safety assessment

Skin sensitisation

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

A key study was identified (CIT, 1997). In this dermal sensitisation study performed according to the OECD guideline No. 406 and in compliance with GLP, the test material was tested in a group of 20 Guinea Pigs (10/sex) using the Magnusson and Kligman method (20 tested animals + 10 control animals). The preliminary study determined the concentration to be used for the induction and challenge phases of the main study. The test material diluted in physiological saline at 10% (w/v) was administered by injection for intradermal induction on Day 1. On Day 7, the animals received a topical application of sodium lauryl sulfate in vaseline (10% w/w), in order to induce local irritation. On Day 8, topical induction was performed with the test material as supplied. For the challenge, on Day 22, the test material was tested undiluted. After a rest period of 14 days, a second challenge was performed on Day 36 under the same experimental conditions.

The sensitivity of the guinea-pigs was satisfactory since 50% of the animals showed a positive reaction with positive control 2,4 -dinitrochlorobenzene.

No clinical signs and no deaths were noted during the study. No cutaneous reaction was noted in the control animals after the first and the second challenge.

In the treated group, after the first cutaneous challenge application, the observed cutaneous reactions were attributed to a sensitising effect of the test substance in 4/20 (20%) animals (score of erythema =2) This result was confirmed after the second challenge application with a positive reaction observed in 3/20 animals.

Under the test conditions, the test material is not a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Harmonized classification:

The substance has no harmonized classification for sensitisation according to the Regulation (EC) No. 1272/2008.

 

Self classification:

Based on the available data no additional self-classification is proposed according to the Annex VI of the Regulation (EC) No. 1272/2008 (CLP) and to the GHS.

No data was available for respiratory sensitisation. However, this substance is not a skin sensitizer, therefore according to Figure R.7.3 -2 of the Chapter R.7 (V 4.1 - October 2015) the chemical is not considered as a respiratory sensitiser.