Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

A Mouse Local Lymph Node Assay is available with a structural analogue of the test substance. The skin sensitising study was performed according to the OECD guideline 429 under GLP conditions with 1,4-Dicyanobutane, (CAS No.: 111-69-3; C6H8N2) that is supposed to have similar properties as the test substance (1,6-Dicyanohexane; C8H12N2). 5 female CBA/J mice per dose were treated with different concentrations (25%, 50% and 100% w/w) of the test substance (> 99% pure) in dimerthyl formamide.The mean disintegration per minute (DPM) was 314, 448, 610 and 443 for 25%, 50%, 100% and vehicle control group, respectively. The corresponding SI values were 0.7, 1.0, 1.4 and 1.0. One animal (100%) died and one moribund animal (50%) was killed during the study, but the deaths were not considered to be substance related, because no symptoms of toxicity were observed in the surviving animals. The study is considered reliable and suitable for assessment as it was performed according to guideline under GLP conditions. Based on the results of this study, the substance is not a skin sensitizer (Invista, 2009).


Migrated from Short description of key information:
Skin sensitisation (LLNA, GLP): not sensitising; Read across CAS No.: 111-69-3

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data available on respiratory sensitisation.

Justification for classification or non-classification

Dangerous substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of skin sensitisation of Directive 67/548/EEC, as amended for the 28thtime in Directive 2001/59/EC, classification for skin sensitisation is not warranted.

 

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

The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the 2ndtime in Directive EC 286/2011, classification for skin sensitisation is not warranted.

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