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Administrative data

Description of key information

In vitro skin and eye irritation studies have been conducted on HFP Kinetic Dimer.  The results of the studies are: 
Eye Irritation: Non-irritating when tested according to OECD 438 (2013).
Skin Irritation: Non-irritating when tested according to OECD 439 (2013).

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)

Additional information

The test article was evaluated for eye irritation potential in the Isolated Chicken Eye (ICE) test. The study was conducted in compliance with OECD GLP regulations. The test method was based on OECD 438 (2013). The isolated chicken eyes were exposed to a single, neat application of 30 uL of the test article for 10 seconds followed by a 20 mL saline rinse. Negative (saline solution) and positive (benzalkonium chloride) controls were tested in parallel. Three parameters were measured to determine possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity, and fluorescein retention of damaged epithelial cells. In addition, histopathology of the corneas was performed after exposure. Positive and negative controls performed as expected, indicating a valid test method. The test article caused very slight corneal swelling (3%), no opacity, and no fluorescein retention. Microscopic examination of test article-treated corneas did not reveal any abnormalities. Based on the results of the study, the test article did not show eye irritation potential and is classified as not irritating.

 

The skin irritation potential of the test article was determined using EpiDerm reconstructed skin membranes. The study was conducted in compliance with OECD GLP regulations. The test method was based on OECD Guideline 439 (2013). Two in vitro skin irritation tests were performed. In both tests, skin membranes were topically exposed to the undiluted test substance for 60 minutes. In the second test, the skin membranes were covered with a glass slide immediately after application to prevent evaporation of the test substance. In both tests, viability of the epidermal cells was assessed using the MTT test after 42 hours of culture. Negative and positive controls were run in parallel. In both tests, all acceptance criteria were met and therefore the study was considered valid. The mean viability of the test article-exposed EpiDerm tissues was 98 +/- 5% and 97 +/- 5% compared to the negative control group, in the first and second test, respectively. Based on the results of the study, the test article did not present evidence of skin irritation potential and is classified as a non-irritant.

Justification for classification or non-classification

Criteria for classifying as a skin or eye irritant are not met.