Registration Dossier

Administrative data

Description of key information

Skin and eye irritation studies conducted to evaluate the irritation potential of CR-39 were performed prior to the adoption of the OECD guidelines and the GLP regulations. The studies are acceptable, well-documented,  which meet basic scientific principles (Klimish et al., 1997). The acute Eye Irritation Study in Albino rabbits with 100% DDC (Endpoint 7.3.2.001 of IUCLID file) is a GLP study (report date 1981-03-24). 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Additional information

Skin irritation

In the "Primary Skin Irritation Test" (Acute Toxicity Studies IBT No. A254, 1971 -09 -10) the exposure period was 24 hours. In accordance with the OECD Guideline 404 Acute Dermal Irritation-Corrosion the exposure period should be normally 4 hours. After 24 hour exposure period in three of the four rabbits, both abraded and non-abraded sites showed severe erythema and edema at 24 and 72 hour reading. Carbonic acid was found to be highly irritating to rabbit skin. Contradictive results were obtained in the irritation tests on the skin of rabbits (data published M.Lacroix et al., 1976, endpoint 7.3.1.003). The test material provoked only minimal changes in the skin after 24 hours (slight erythema in certain animals). The exposure period of 24 hours is not realistic to humans. Therefore, the study "Skin Irritation Studies of CR-39 Monomer" (report dated 1976 -06 -04) was taken forward for risk characterization. In this study undiluted test material (0.5 mL) was applied to one intact and one abraded skin site on rabbits (3/sex) under occluded conditions for 6 hours and assessed for up to 13 days after exposure. At 48 hours, moderate to severe erythema were noted on all sites and by 72 hours, irritation progressed to necrosis with severe erythema and very slight edema. Reddened and blackened skin at all sites was noted. By 13 days, edema, but not erythema, resolved. "...there is no dose relationship between the reaction that occured in the first treatment and the third treatment and the pattern of reaction inconsisitent and not reproducible... The reaction seems not to depend upon the animal that is being tested or the amount of solution or site selection and thus, one can conclude that there certainly is a rection taking place but being not reproducible and one must consider this is a spurious result." (from the conversation letter of Dr. M. Vinegar, Toxicologist and P.T. Breen, Dermatologist, dated 1979- 03 -12). Carbonic acid, oxydiethylene diallyl ester is irritating to rabbit skin.

Eye irritation

In the earlier study "Eye Irritation Test"[(Acute Toxicity Studies IBT No. A254, 1971 -09 -10) Endpoint 7.3.2.002] undiluted test material (0.1 mL) was instilled in the conjunctival sac of the right eye of five rabbits. Test eyes were not washed. Irritation was scored at 1 minute, 1, 24 and 72 hours and 7 days after administration. Conjunctival redness and slight discharge was seen which was resolved by 24 – 72 hours. In this study the test material was slightly irritating to rabbit eyes. In the Acute Eye Irritation Study in Rabbitts with 100% DDC (report date 1981 -03 -24) the principle of test design was the same as in the previous one except the number of animals. 6 not rinsed and 3 rinsed animals were tested. The cornea and the iris were not affected, the conjunctiva was affected by one- and six-hour examination and the lesions were fully reversible within 24 hours. The one-hour interval provided the highest mean score (8.0) for 100% DDC (diallyl diglycol carbonate) and was therefore used as the primary irritation index and classified the test compound as minimally irritating using the method of Draize. Instillation of water into the treated eyes of three rabbits did not change the classification but decreased the mean score to 3.0. The test material is considered to be slightly irritating to eyes.


Effects on skin irritation/corrosion: irritating

Effects on eye irritation: slightly irritating

Justification for classification or non-classification

Eye irritation

According to the guidance to Regulation (EC) No 1272/2008 (CLP Regulation) [ECHA Guidance on the Application of the CLP Criteria, Aug 2009; p. 249;http://guidance.echa.europa.eu/docs/guidance_document/clp_en.pdf], Diallyl Diglycol Carbonate does not meet criteria for classification as eye irritant. No statement will appear on the label.

Skin irritation

The classification is warranted according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulations No 1272/2008.

DSD: Xi,R38; Irritant; Irritating toskin;

GHS: Skin irritation Cat 2.