Registration Dossier

Administrative data

Description of key information

There is no study on skin and eye irritation available with the test item 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane  itself. Existing data from a skin as well as an eye irritation study with the surrogate substance  2-Perfluoralkylethyljodide (CAS no. 85995-91-1) are taken for the evaluation because the main compound of this substance is the 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane with about 42 % . Due to workplace safety aspects the read across was chosen to demonstrate that there is low potential of irritany of this class of substances.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

The acute dermal irritating potential of the test item was investigated in three New Zealand White rabbits. 500 mg of the undiluted test substance was applied to the shaved skin and covered semi occlusive for a 4 hour exposure. Observation periods were approximately 1h, 24 h, 48 h and 72h after removing of the patch. The overall irritation score was determined to be 0.22. Based on the results of the test substance has not to be classified.

Eye irritation:

The acute eye irritating potential of the test item was investigated in three New Zealand White rabbits. The test item was applied by instillation of 100 mg of the undiluted test substance into the left eye of each of three rabbits. Irritation effects were scored approximately 1h, 24 h, 48 h and 72h after test item instillation. 24 hours after instillation the eyes were rinsed with warm physiological saline solution.

The mean score was calculated across 3 scoring times (i.e. 24h, 48h and 72h after instillation) for each animal. The individual mean scores for corneal opacity and changes of the iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.33, 0.00 and 0.66 for reddening and 0.00 for chemosis for all three animals. Based on the results of this test the test substance has not to be classified.

Justification for classification or non-classification

According to the CLP regulation and based on the results obtained in the above mentioned OECD 404 and 405 studies the surrogate substance has not to be classified. The same applies for the substance under evaluation.