Registration Dossier
Registration Dossier
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EC number: 224-923-5 | CAS number: 4553-62-2
Endpoint summary
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 available and considered as the key study. In a dermal sensitization study performed according to the OECD test guideline No. 429 and in compliance with Good Laboratory Practice (Gerbeix, 2010), 2 -methylglutaronitrile was tested in female CBA/J mice using the Local Lymph Node Assay.
A preliminary test was first performed in order to define the concentrations of test item to be used in the main test.
In the main test, groups of four animals received 2 -methylglutaronitrile at the concentration of 5, 10, 25, 50 or 100% in dimethylformamide. A negative and a positive control groups were included in the study.
Due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles. A solution was obtained at the maximum tested concentration of 50%.
No mortality related to treatment and no clinical signs were observed during the study.
No cutaneous reactions and no notable increase in ear thickness were observed in the animals of the treated groups.
A significant lymphoproliferation was noted in the positive control group given HCA at 25%, the study was therefore considered valid. No lymphoproliferation was noted at any tested concentration of 2 -methylglutaronitrile.
Under the experimental conditions of this study, 2 -methylglutaronitrile is not considered as a skin sensitizer.
Migrated from Short description of key information:
Not sensitizing (Kr: 1, OECD 429, GLP)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No data was available
Justification for classification or non-classification
2 -methylglutaronitrile is not classified in the Annex VI of the CLP regulation (1272/2008).
Skin sensitisation/self classification:
No lymphoproliferation was noted at any tested concentration of 2 -methylglutaronitrile (OECD 429, Kr: 1). Based on these results,
2-methylglutaronitrile is not considered as a skin sensitizer and no classification is required according to the CLP regulation (1272/2008) and to the Directive 67/548/CEE.
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