Registration Dossier

Administrative data

Description of key information

Skin:
In a primary skin irritation study, 32/73/5.L, 500 mg of Compound TK 11339 (dioctyltin dichloride), moistened with a 50% PEG 400 in water solution, was applied to both shaved and abraided skin of male and female New Zealand White rabbits. The gauze pad keeping the test substance in contact with the skin was removed after 24 hours. Animals then were observed for 72 hours.
 
Compound TK 11339 is slightly irritating to skin of New Zealand White rabbits when tested according to the method used.
Eye:
In a primary eye irritation study, 34/73/5.L, 80 mg of Compound TK 11339 (dioctyltin dichloride) was instilled into the conjunctival sac of the left eye of male and female New Zealand White rabbits and left for 30 seconds before washing. Animals then were observed for 72 hours. Total eye irritation out of 110 was determined.
 
Compound TK 11339 is slightly irritating to the eyes of New Zealand White rabbits when tested according to the method used.
According to the EU classification system the test material will not be considered irritating to the eye.

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:
no adverse effect observed (not irritating)

Additional information

Skin:

In the key study (Drake, 1973) mild irritation was noted with abraded and non-abraded skin. Although no data was provided for 48 hours, and full recovery data (up to 14 days for classification purposes) was not reported, the scores obtained during at 24 hours was not sufficient to trigger classification, and by 72 hours the animals were nearly fully recovered (oedema had completely diminished, and erythema had scores of 0.67 and 0.50 in intact and abraded skin respectively). A reliability score of 2 was assigned to the study according to the criteria of Klimisch 1997. Although the study did contain some deficiencies (i.e. no 48 hour observation, and a lack of recovery period), the results were considered reliable and adequate for assessment.

Eye:

In the key study (Drake, 1973) slightly irritation was seen in the eyes at days 1 and 2, however all irritation has gone by day 3. The scores were lower than those given in EU classification systems and so the test material was not considered to be an eye irritant.

A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997 as the study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Justification for classification or non-classification

Skin:

The key parameter chosen for eye irritation was less than the criteria set out in Directive 67/548/EEC and also Regulation (EC) 1272/2008, therefore classification for skin irritation was not considered to be necessary.

Eye:

The key parameter chosen for eye irritation was less than the criteria set out in Directive 67/548/EEC and also Regulation (EC) 1272/2008, therefore classification for eye irritation was not considered to be necessary.