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:

The skin sensitisation potential of Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetraminewas evaluated in the Local Lymph Node Assay (LLNA), according to OECD Guideline 429 and GLP. A preliminary study was conducted in one female CBA/Ca mouse to determine concentrations to be used for the main study. Female CBA/Ca mice (4 per group) where used in the main study. The test material was prepared for administration at 0, 10, 25 and 50% w/v in 80% v/v acetone in olive oil. The test material or vehicle control was applied to the outer aspect of the auditory pinnae of the mice once daily on Days 1, 2 and 3. On Day 6 a 20 µCi dose of tritiated ³H-methyl thymidine was injected intraveneously into each mouse. Approximately 5 hours later the auricular lymph nodes were recovered from each animal. Nodes from the same treatment group were pooled and suspensions of the cellular components of the lymph nodes were prepared in 5% w/v trichloroacetic acid and processed through a scintillation counter. The DPM value (disintegrations per minute in a ten minute period) was used to calculate the DLM value (disintegrations per minute per lymph node). The DLM value of each test group was divided by the DLM value for the vehicle control group to provide the Stimulation Index for each group. Stimulation indices of 9.9, 9.0 and 8.1 were obtained for test concentrations 10%, 25% and 50%, respectively. On the basis of these findings, Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine is considered to be a skin sensitiser.


Migrated from Short description of key information:
Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetramine was considered to be a skin sensitiser in the Local Lymph Node Assay (LLNA) conducted according to OECD Test Guideline 429.

Justification for selection of skin sensitisation endpoint:
Sole study providing data from a guideline compliant study. Under the conditions of the study, the test substance was found to be a skin sensitiser.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Fatty acids, C18-unsatd., dimers, polymers with oleic acid and triethylenetetraminewas considered to be a skin sensitiser in the local lymph node assay. On this basis, the substance meets the criteria for classification for skin sensitisation as: Category 1, H317 “May cause an allergic skin reaction” according to Regulation (EC) No 1272/2008 and as Xi, R43 “May cause sensitisation by skin contact” according to Directive 67/548/EEC.