Registration Dossier

Administrative data

Description of key information

Irritation studies for skin and eye were conducted in rabbits with an aqueous formulation containing 78-80% active ingredient, demonstrating that the test material was a skin irritant and causing serious damage  to the eye.  There were no scores available for both dermal and eye irritation, however based on the category findings, the test item is considered irritating for skin (CLP category 2) and causing severe eye damage (CLP category 1). 

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)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

A key in vivo skin irritation study (Shaffer, 1957) was available where single doses of the registered substance containing 80% active ingredient were applied to the closely-clipped skin of male rabbits for 24 hours under occlusion. Doses given were 2.5, 5 and 10 mL test item/kg body weight, corresponding with ca. 9, 18 and 36 g active ingredient. At the dose of 10 mL/kg there was very severe erythema, edema and necrosis of the skin. At 5 and 2.5 mL/kg bw, erythema and edema were initially quite severe, but the edema subsided within 24 to 48 hours. Erythema, however, persisted for 4 to 5 days. The 2 latter doses were considered as worst case situation volumes (9 and 18 g instead of 0.5 g), therefore the test item is considered to be irritating but not corrosvie to skin. There were no scores available.

Eye irritation

A key study for eye irritation was conducted similar to OECD 405 method (Shaffer, 1957), where 0.05 mL of the registered substance containing 80% active ingredient was instilled into the conjunctival sac of the left eye of each of 5 male albino rabbits. There was an immediate reaction of pain, but by four hours after the dose no more serious signs of irritation than profuse discharge was observed. At observation on the following day, the discharge had lessened somewhat, but a moderate degree of conjunctivitis had developed, together with extreme swelling of the lids in two instances. The intensity of these reactions was variable within the group, so that in the case of the two animals noted the severity of irritation was considerably more pronounced than with the others and, in addition, they displayed signs of corneal involvement characterized by diffuse clouding of the entire area. These differences in response are probably attributable to differences in amount of the dose washed out by the initial discharge. However, by the fourth day the pattern of injury was well-developed in all eyes and consisted of moderate discharge, partial closing of the lids by swelling, moderate conjunctivitis, sluggish reaction of the iris to light, and diffuse corneal opacity. This condition persisted with no appreciable improvement for the reminder of a 7-day observation period. There were no scores available.

Further information supporting the classification is provided in the read across justification for the Diester category, showing that all substances in the group (except 1 which was not irritating) were irritating for skin and all were group classified to cause severe eye damage (justification with data matrix separately attached in Section 13).


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
key study

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the results the test item containing 80% active ingredient needs to be classified for skin irritation according to the Directive 67/548/EEC, Annex VI with symbol Xi and the indication of danger “irritant”; the following risk phrase shall be assigned: R38 - Irritating to skin.  According to CLP regulation (No. 1272/2008 of 16 December 2008), the substance is classified as Category 2, with signal word 'Warning' and hazard statement: H315 -Causes skin irritation. 

Based on the results and read across with category member(s), the test substance containing 80% active ingredient is classified to the Directive 67/548/EEC, Annex VI with symbol Xi and risk phrase R41- Risk of serious damage to eyes. According to CLP regulation (No. 1272/2008 of 16 December 2008), the substance is classified as Category 1, with signal word 'Danger' and hazard statement: H318 -Causes serious eye damage.