Registration Dossier

Administrative data

Description of key information

The analogue substance 9-octadecenoic acid caused changes in the epidermis, the corium and in hair follicles after repeated applications to the skin of rats.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Species:
rat
Quality of whole database:
The publication was assessed as klimisch 4. As the dose concentrations are not specified precisely, an assessment on the basis of these results is not possible.

Additional information

No adequate animal data are available and no epidemiological studies investigating the repeated dose toxicity of the test substance were identified. However, data from a structural analogue (read across substance) are available. The analogue substance 9-octadecenoic acid was applied to the clipped back of rats (Long-Evans and Albino). Therefore, the substance was swabbed daily with the substance for 5 to 14 days. After this period, biopsies were conducted and the skin was fixed for microscopical examination. Further, the skin of the living rats was observed and biopsies were further taken. As a result, some changes in the epidermis, dermis and the hair follicles were found, indicating penetration of the analogue substance. The substance affected the epithelial ling of hair follicles and led to infiltration of the corium with lymphocytes.


Justification for selection of repeated dose toxicity dermal - local effects endpoint:
only one publication available

Justification for classification or non-classification