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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Skin irritation: not irritating according to the test information. However, taking into account that the 
composition and purity of the test material was not reported, it is unknown whether the test
substance contained cresol in the same amount as the industrial product. The presence of <3%
cresol triggers skin irritation cat 2.



Eye irritation: slightly irritating according the test information. However, taking into account that the
composition and purity of the test material was not reported, it is unknown whether the test
substance contained cresol in the same amount as the industrial product. The presence of <3%
cresol triggers eye irritation cat 2.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation:


Three studies were available. Two of them were considered as not reliable (Kr: 3) and a study of Guilot, 1981 was identified as the key study (Kr: 2)


This skin irritation and corrosion study was performed similarly to the OECD test guideline No. 404 (Draize test). 4 New Zealand White rabbits were exposed to 0.5 mL of undiluted 2-Methylglutaronitrile. Intact and abraded skin of each animal (2 different sites) was in contact with the test substance. Test sites were covered with an occlusive dressing for 24 hours and weren’t washed after this period. Changes were observed at 25 and 72 hours (1 hr and 48 hr after the dressing removal). Mean score of intact skin were 0.0 for erythema and edema. Thus 2 -methylglutaronitrile is considered as not irritating to the skin.
Taking into account that the composition and purity of the test material was not reported, it is unknown whether the test substance contained cresol in the same amount as the industrial product. The presence of <3% cresol triggers skin irritation cat 2. 


 


Eye irritation


Two studies were available. One of them was considered as not assignable (Kr: 4). A key study was identified (Guillot, 1981). In an eye irritation study performed similarly to the OECD test guideline No. 405 (Draize test), 0.1 mL of undiluted 2-Methylglutaronitrile was instilled into the conjunctival sac of left eye of 4 New Zealand White rabbits. The eyes of the animals were not rinsed after instillation. Changes were observed at 1, 24, 48, 72, 96 and 168 hours after dosing and grading according to Draize scale. 2-Methylglutaronitrile produced chemosis (mean score 0.42), conjunctival redness (mean score 0.25), corneal lesions (mean score 0.25), and iris lesions (mean score 0.25). All of these effects were totally reversed after 3 days. Therefore 2 -methylglutaronitrile is considered as slightly irritating.
Taking into account that the composition and purity of the test material was not reported, it is unknown whether the test substance contained cresol in the same amount as the industrial product. The presence of <3% cresol triggers eye irritation cat 2. 


 


Respiratory irritation:


No data was available.



Effects on eye irritation: slightly irritating

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

2 -Methylglutaronitrile is not classified in the Annex VI of the CLP regulation (1272/2008). A self-classification is proposed as followed:

1-Skin irritation:

As no signs of skin irritation were observed in a dermal irritation study with 2-Methylglutaronitrile conducted similarly to OECD test guideline No. 404, 2-Methylglutaronitrile is considered as not irritating to the skin according to the CLP Regulation (1272/2008) and to the Directive 67/548/EC.

2- Eye irritation:

- Not irritating according to the CLP Regulation (1272/2008) as the mean scores obtained in the key study (OECD 405) were all under the limit scores (1 or 2 depending on the observed parameter) for classification.

- Not irritating according to the Directive 67/548/EEC as the mean scores obtained in the key study (OECD 405) were all under the limit scores (1, 2 or 2.5 depending on the observed parameter) for classification.