Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Regarding the skin irritating potential of methyl cyanoacetate, no studies are available. Nevertheless, according to a MSDS by Evonik (2008), methyl cyanoacetate was slightly irritating to the skin of rabbit when tested according to the OECD TG 404; no scoring data were available.
Referring to the eye, the ECETOC has published a series of rabbit eye irritation data referring to 132 chemicals and 149 in vivo eye irritation studies, including methyl cyanoacetate (ECETOC Technical Report No. 48 (2), June 1998). Particular attention was given to purity data of the chemicals, and only OECD guideline studies conducted under GLP conditions were considered. Thus, the data reported by the ECETOC are considered to be scientifically acceptable and suitable for assessment of the eye irritating potential of methyl cyanoacetate, which was found to be an irritant to the eye of rabbit. For support, the in vitro result of a modified HET-CAM Test designated as HET-CAM-TSA test was considered since the test item was found to be irritating. According to the MSDS by Evonik mentioned above, methyl cyanoacetate was found to be slightly irritating to the eye of rabbit when tested according to the OECD TG 404; as for skin, no scoring data were available.

Key value for chemical safety assessment

Additional information

Skin irritation:

According to a MSDS by Evonik (2008), methyl cyanoacetate was slightly irritating to the skin of rabbit when tested according to the OECD TG 404; no scoring data were available.

Eye irritation:

Methyl cyanoacetate was tested for eye irritation according to the OECD TG 405, under GLP conditions (ECETOC, 1998). For this purpose, 0.1 mL of unchanged test item was instilled into the conjunctival sac of one eye of each of 3 rabbits. It was not specified whether the treated eyes had been rinsed of not. The animals were observed for eye reaction during 14 days. The reading time poinst were: 1 hr, 1, 2, 3, 7 and 14 d. Irritation was scored according to Draize (J Pharmacol Exp Ther 82: 377 -390, 1944).

Signs of irritation were seen in all 3 rabbits tested with methyl cyanoacetate and almost were reversible within 7 days following treatment. Corneal opacity and iritis did not exceed a mean scoring value of 1, respectively.

Conjunctival redness reached a mean score of 3 for each animal, regarding the relevant reading time points of 24, 48 and 72 h. The mean scores for chemosis were 2.67, 2.33 and 1.33, for each animal respectively.

Discharge graded 1 was reported for all 2 animals at 24, 48 and 72 h. In 2 cases, discharge already was seen at time point 1 hour, and was graded 1 and 2, respectively. The finding was fully reversible in all animals at day 7.

Considering the scorings reported above, methyl cyanoacetate is irritating to the eye of rabbit according to current evaluation criteria.

A series of 60 substances including methyl cyanoacetate was tested in a modified HET-CAM Test designated as HET-CAM-TSA, which had been developed by Gilleron et al. (1996). Based on the results of the test, an irritation score IS of 16.31 ± 1.23 was determined according to the formula of Kalweit et al. (1990) for methyl cyanoacetate. According to the classification of Spielmann et al. (1991), substances with a score > 5.0 are classified as irritant. Thus, methyl cyanoacetate tested in vitro in the HET-CAM-TSA test was irritating to the eye. This was in accordance with the result from the in vivo test reported above.

According to the MSDS by Evonik mentioned above, methyl cyanoacetate was found to be slightly irritating to the eye of rabbit when tested according to the OECD TG 404; as for skin, no scoring data were available.

Respiratory irritation:

No data available.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Whereas data regarding skin irritation are insufficient for assessment, the result of an in vivo guideline eye irritation study which was supported by in vitro data revealed that methyl cyanoacetate is an eye irritant according to current evaluation criteria. Regarding scoring values, the test item is to be classified as Xi R36 according to the EU Directive 67&548/EEC, and in Category 2 according to the CLP Regulation (EC) 1272/2008.