Registration Dossier

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:
Non-human information Cloquintocet-mexyl has been tested in an optimization study in guinea pigs conducted according to OECD test guideline 406 (Schoch M, 1987). Groups of 20 guinea pigs were treated with 0.1% cloquintocet-mexyl for induction and challenged with 1% cloquintocet-mexyl. All 20 guinea pigs in the treated group showed a positive reaction 24 and 48 hours after challenge. Cloquintocet-mexyl was found to be a skin sensitiser. Human information There is no human information concerning skin sensitisation.

Migrated from Short description of key information:
In a guideline, GLP skin sensitisation study in guinea pigs cloquintocet-mexyl gave a positive response in all 20 animals in the treated group. Cloquintocet-mexyl should be classified as a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data animal or human data have been found with regard to respiratory sensitisation.


Migrated from Short description of key information:
No data animal or human data have been found with regard to respiratory sensitisation.

Justification for classification or non-classification

Data on cloquintocet-mexyl indicate that it causes an allergic skin reaction in guinea pigs and should therefore be classified as a sensitiser by skin contact:

- under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, Annex VI, 3.2.7.2.

- under Regulation (EC) 1272/2008, Annex I, Part 3, 3.4.2.2.

There is no data on the respiratory sensitisation potential of cloquintocet-mexyl.

Categories Display