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:

postive reactions in 15% of test animals is required for a positive senisitising result in a non-adjuvant test. Fewer than prescibed test animals were utilised, therfore decreasing the power of the study to detect a sensitiser. 40-50% of animals displayed a positive result on first challenge, 10-20% of animals displayed a positive reaction on rechallenge, with a lower concentration of test material, and 40% of animals displayed reactions on second rechallenge, with a lower concentration of test substance. therefore, according to guidelines, this substance is a sensitser.


Migrated from Short description of key information:
In a dermal sensitization study with sodium 4-icosylbenzenesulfonatein mineral oil, guinea pigs (5/sex) were tested with a Beuhler test. 
 
  In this study,sodium 4-icosylbenzenesulfonateis a dermal sensitizer.

Justification for selection of skin sensitisation endpoint:
postive reactions in 15% of test animals is required for a positive senisitising result in a non-adjuvant test. Fewer than prescibed test animals were utilised, therfore decreasing the power of the study to detect a sensitiser. 40-50% of animals displayed a positive result on first challenge, 10-20% of animals displayed a positive reaction on rechallenge, with a lower concentration of test material, and 40% of animals displayed reactions on second rechallenge, with a lower concentration of test substance. therefore, according to guidelines, this substance is a sensitser.

Respiratory sensitisation

Endpoint conclusion
Additional information:

No aplicable

Justification for classification or non-classification

Adverse effect observed