Registration Dossier

Administrative data

Description of key information

Skin sensitisation (OECD TG 429): Sensitising (EC3 of 19.2%)

Respiratory sensitisation: Not sensitising in absence of human data and absence of structural alerts for respiratory sensitisation.

Key value for chemical safety assessment

Skin sensitisation

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

Skin sensitisation in the LLNA

The skin sensitisation potential of the test substance has been tested according to the OECD TG 429 (Local Lymph Node Assay) guideline. At 2.5, 5, 10, 25 and 50% the substance showed SI values of 1.7, 1.5, 1.9, 3.7 and 8.1, respectively. No signs of irritation or other toxicity were detected. The EC3 was calculated to be 19.2 and the NOEC 10%. The substance was found to be a skin sensitiser under the conditions of this test.

Skin sensitisation in HRIPT tests supporting information not used for DNEL derivation

In addition, a human Repeated Insult Patch Test (hRIPT) is available in which 41 volunteers exposed to 2.5% test substance in alcohol SDA 39. 0.5mL sample was applied to the skin with a 1 x 1 inch patch. The patch was removed 24 h after application. The patch was applied on the same area each time during the 9 inductions. For the final challenge duplicate patches were applied, one on the original test site and one on a skin site that did not previously receive test patches. 41 panellists showed little or no primary irritation. There was no evidence of sensitisation (IFF 1971).

Respiratory sensitisation

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

The substance is not a respiratory sensitiser in absence of human data indicating such effects. In addition, the respiratory sensitisation is assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-2, 2014).

1)     The substance is a skin sensitiser;

2)     The substance does not belong to the di-isocyanates;

3)     the substance has no structural alerts or is structurally related to chemicals causing respiratory sensitisation as presented in Table R.7.3-1 in the ECHA guidance of 2008 or those provided in the following document: http://ec.europa.eu/health/scientific_committees/docs/annex6_respiratory.pdf

Therefore the substance is not considered to be a respiratory sensitiser.

Justification for classification or non-classification

Based on the available information, the substance should be classified as sensitising to the skin in accordance with the criteria outlined in the EU CLP Regulation (1272/2008/EC and its amendments) resulting in Skin Sens. 1B / H317: May cause an allergic skin reaction.

In absence human data indicating respiratory sensitisation and using the ITS in the ECHA guidance (R.7a, 2014) the substance is not considered to be a respiratory sensitiser in accordance with the criteria outlined in the EU CLP (EC 1272/2008 and its amendments)