Dibutyltin dichloride

Endpoint summary

Description of key information

The following studies have been submitted to address the skin irritation endpoint:
Schobel C (1991a). ZK 22.663: Local dermal tolerance test in rats after a single application and a subsequent rinsing. Testing laboratory: Schering AG, Pharmaceutical research, Bergkamen, Germany. Report no.: IC 1/91. Owner company: Crompton GmbH, Postfach 1620, D-59180, Bergkamen, Germany. Report date: 1991-06-13.
Schöbel C (1989). ZK 22.663: Local dermal tolerance test in rabbits after a single application. Testing laboratory: Schering AG, Pharmaceutical Research, Bergkamen, Germany. Report no.: IC 29/89. Owner company: Crompton GmbH, Postfach 1620, D-59180, Bergkamen, Germany.
Both studies have been allocated a Klimisch score of 2.
The following study has been submitted to address the eye irritation endpoint:
Bucva NF (1971). Primary eye irritation of dibutyl tin dichloride (DM-8122) in rabbits. Testing laboratory: Affiliated Medical Enterprises, Inc., Princeton Pike, P. O. Box 57, Princeton, New Jersey, 08540, USA. Report no.: 120-697-12-70. Owner company: M & T Chemical Co. Report date: 1971-03-15.
This study has been allocated a Klimisch score of 2 and is the key study for this endpoint.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

In the first dermal irritation studies, a single rabbit was used, because application of the substance for 4 hours leads to necrosis reaching the skeletal muscle. In the second study, 2 male and 2 female Wistar rats were used, and the treated sites were washed with soap and then rinsed with like-warm water 5 minutes after application. Decontamination procedures were ineffective and spread the substance also to the untreated skin where signs of irritation were observed as well. The substance was corrosive to the skin, requiring the sacrifice of the surviving animals on day 4.

Similarly, in the eye irritation study, rinsing of the treated eye with luke-warm water 2 or 4 seconds after instillation did not alleviate the effects, and complete enucleation of the eye was noted at necropsy.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on animal data, the substance is corrosive to the skin and eye and has to be labelled with C; R34 – causes burns in accordance with directive 67/548/EEC. Accordingly, in line with regulation (EC) No 1272/2008, the substance should be labelled with Skin Corrosion 1B (H314 Causes severe skin burns and eye damage) and Eye damage 1 (H318 Causes serious eye damage) and assigned the signal word Danger.