Registration Dossier

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

In a skin sensitisation study performed according to OECD 406 and in line with GLP using DBT(2 -EHMA) as the test material, 10 week old male and female Pirbright White Guinea Pigs were exposed to the test material in a maximisation test.

Read-across from DBT-(2 -EHMA) to dibutyltin dimethoxystannane was considered appropriate, as a group dibutyltins are classified as sensitizers. The data was presented as supporting informationto the classification.

Migrated from Short description of key information:
The following study was submitted in support of the skin sensitisation endpoint:

Maurer (1986) TK 11638/1 Skin Sensitization Test in the Guinea Pig. Modified Maximization Test. Report Number: 86106. Report date: 1986-12-18.

The study has been performed to GLP and in line with appropriate guidelines but DBT(2-EHMA) is the test material and so has been allocated a Klimisch score of 2 on the basis that it has been used as read-across.

Justification for classification or non-classification

The test substance was found to be sensitising according to 67/548/EEC and should therefore be classified as R43 - May cause sensitisation by skin contact. According to Regulation (EC) no 1272/2008 the test substance would be classified as a Category 1 Sensitizer; H317: May cause an allergic skin reaction, accompanied with the signal word 'warning'.