Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There are a total of 4 skin sensitization studies on the hydrotrope category substances.

 

The key study for skin sensitisation is a 1983 study on sodium cumene sulphonate. This is an OECD 406 guideline Buehler study conducted according to GLP guidelines. One group of twenty female guinea pigs had occlusive epicutaneous exposures to 0.4 mL of undiluted test material. There were three 6-hour per week inductions followed by a challenge on day 28. Readings at 21 and 45 hours indicated there were no sensitization responses. The 3 other studies also gave negative responses for sensitization.


Migrated from Short description of key information:
There are 4 skin sensitisation studies for the hydrotrope category substances. The 4 studies consistently support a conclusion that these substances are "not sensitising".

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
N/A

Justification for classification or non-classification

The available studies demonstrate that the hydrotrope category substances are not skin sensitizers. Therefore a classification is not justified.