Registration Dossier

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 Maurer, 1986, 10 week old male and female Pirbright White Guinea Pigs were exposed to TK 11638/1 (a similar material to the registered substance) in a maximisation test. 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.


Migrated from Short description of key information:
The following study was submitted in support of the skin sensitisation endpoint. The data are available from testing on a structurally analogous substance:

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 Sensitiser; H317: May cause an allergic skin reaction, accompanied with the signal word 'warning'.

Although the data are conducted on a struturally analogous substance it is considered justifiable to read across the data to the registered substance on the basis that several dibutyl tin compounds are classified as sensitisers and the registrant is voluntarily applying the most severe classification and labelling on the basis of data available, thus avoiding further animal exposure.