Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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'.