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Toxicological information

Endpoint summary

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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:

Skin Sensitisation

The skin sensitization was evaluated in a GLP and EU Method B.6 study with Dunkin-Hartley Guinea Pig. 20 Guinea Pig per group were induced with Chiguard 380/Chiguard 380W at concentration of 5% w/v in Alembicol D and challenged at concentration of 30% w/v and 60%w/v Chiguard 380/Chiguard 380W in Alembicol D. Two studies were conducted. In the first study, five animals (i.e. 50 %) showed a positive result. Furthermore it is peculiar that in the second study, although a few animals reacted positive, no further challenge was performed as in the first study.

Migrated from Short description of key information:

Skin sensitisation: sensitising (EU Method B.6, GPMT)

Respiratory sensitisation

Endpoint conclusion
Additional information:

Migrated from Short description of key information:

No relevant information is available

Justification for classification or non-classification

Based on the available information in the dossier, the substance Chiguard 380/Chiguard 380W (CAS#18600-59-4) need to be classified as Sensitisation (Xi, R43) when considering the criteria outlined in Annex VI of 67/548/EEC and classified as Skin Sens. 1B when considering the criteria outlined in Annex I of 1272/2008/EC and its adaption (EU) No 286/2011.