Dibutyltin di(acetate)

Endpoint summary

Description of key information

The irritancy and corrosivity potential of dibutyltin di(acetate)  to the skin and eye was addressed in a tiered approach. Primarily the potential for skin corrosion of the test material was assessed in the following in vitro study using a validated model:
Warren N (2010) IN VITRO SKIN CORROSION IN THE EPISKIN(TM) RECONSTITUTED HUMAN EPIDERMIS MODEL. Testing Laboratory: Harlan Laboratories Limited, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160, Brussels, BELGIUM. Report No.: 3109/0028. Report date: 2010-07-19
The study was performed in compliance with GLP and using a validated model, the study was therefore assigned a reliability score of 1.  
The test material was classified as Corrosive to the skin according to the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004). The test material was classified as corrosive to the skin according to EU labelling regulations Commission Directive 2001/59/EC. The symbol “C”, the indication of danger “Corrosive” and the risk phrase R 34 “CAUSES BURNS” are therefore required. The UN packing group II is also required.
Eye:
In accordance with column 2 of REACH annex VIII, it is considered justifiable to omit the eye irritation study if the substance is classified as corrosive to the skin and provided that the registrant classifies the substance as an eye irritant.

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

The positive results from the in vitro skin corrosion study, Warren N (2010), negates the need for further testing. The key study (Warren N, 2010), was performed to the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004) and in compliance with GLP and is therefore considered reliable and adequate for assessment. Accordingly the study was assigned a reliability score of 1 in line with the criteria reported in Klimisch (1997).

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Skin:

The test material will be classified as corrosive to the skin according to Directive 67/548/EEC.

The symbol “C”, the indication of danger “Corrosive” and the risk phrase R 34 “CAUSES BURNS” are therefore required.

According to Regulation (EC) no 1272/2008, the test substance will be classified as a Corrosive; Category 1B and so will have the hazard statement H314: causes severe skin burns and eye damage and the 'Danger' symbol.

Eye:

In accordance with column 2 of REACH annex VIII, it is considered justifiable to omit the eye irritation study if the substance is classified as corrosive to the skin and provided that the registrant classifies the substance as an eye irritant.

With this in mind, corrosive, R34; applies to both skin and eyes according to Directive 67/548/EEC.

According to Regulation (EC) no 1272/2008, the test substance will be classified as a Eye Category 1 and so will have the hazard statement H318: causes serious eye damage and the 'Danger' symbol.