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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

 With the test item 2 -Cyano-2 -methyl-propanoic acid-methyl ester a dermal irritation/corrosion test in New Zealand White rabbits was performed according to the method described in OECD guideline 404. 2 -Cyano-2 -methyl-propanoic acid-methyl ester does not show a skin irritation potential under the test conditions chosen.
With the test item 2 -Cyano-2 -methyl-propanoic acid-methyl ester an eye irritation/corrosion test in New Zealand White rabbits was performed according to the method described in OECD guideline 405. 2 -Cyano-2 -methyl-propanoic acid-methyl ester showed a irritation potential under the test conditions chosen.

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:

An in vitro study using the EpiDerm(TM) human skin model showed the non-corrosivity of 2 -Cyano-2 -methyl-propanoic acid-methyl ester. In order to further assess the acute skin irritation potential of the test substance, a dermal irritation/corrosion test in New Zealand White rabbits was performed according to the method described in OECD guideline 404 . An amount of 0.5 mL of the test substance was applied for 4 hours to the intact skin of three rabbits, using a patch of 2 .5 cm x 2 .5 cm, covered with semiocclusive dressing . After removal of the patch the application area was washed off . The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch . Slight erythema was observed in the animals up to 24 hours after removal of the patch . The cutaneous reactions were reversible in all animals within 48 hours after removal of the patch at latest . The average score (24 to 72 hours) for irritation was calculated to be 0 .1 for erythema and 0.0 for edema . Considering the described cutaneous reactions as well as the average score for irritation, 2-Cyano-2-methyl-propanoic acid-methyl ester does not show a skin irritation potential under the test conditions chosen (BASF, 2005).

Eye irritation:

In an in vitro study using the chorionallantoic membrane in incubated hen eggs (HET-CAM test) 2-Cyano-2-methyl-propanoic acid-methyl ester did not produce changes indicative for severe eye irritation . In order to further assess the acute eye irritation potential of the test substance an eye irritation test in rabbits was performed according to the method described in OECD guideline 405 .An amount of 0.1 mL of the test substance was applied to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals) . About 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and then in weekly intervals until day 14. Corneal opacity, moderate iritis, slight to severe conjunctival redness, slight conjunctival chemosis and slight to severe discharge were observed in the animals during the course of the study. In addition, suppuration, contracted pupil and injected scleral vessels in a circumscribed area or circular were noticed in the animals during the observation period. The ocular reactions were reversible in all animals within 14 days after application at latest. The average score (24 to 72 hours) for irritation was calculated to be 0.7 for corneal opacity, 0.9 for iris, 1 .7 for conjunctival redness and 0.4 for chemosis.

Considering the described ocular reactions as well as the average score for irritation, 2-Cyano-2-methyl-propanoic acid-methyl ester shows a eye irritation potential under the test conditions chosen.


Effects on eye irritation: irritating

Justification for classification or non-classification

Classification for skin irritation is not warranted according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (GHS (EU-CLP)). 2 -Cyano-2 -methyl-propanoicacid-methylester has to be classified for eye irritation according to Regulation (EC) No 1272/2008 (GHS (EU-CLP)) criteria.