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Diss Factsheets

Administrative data

Description of key information

Two Primary Skin Irritation studies have been conducted.  No signs of irritation were evident in either study.
Two eye irritation studies were conducted on perfluorotributylamine. No sign of eye irritation was seen at 24, 48 and 72 hours.

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

In the first skin irritation study, test article was applied to intact and abraded skin of six albino rats and then covered with a semi-occlusive dressing. The dressing was removed after 24 hours. There were no signs of irritation at the 24 hour reading. The sites were read again and 72 hours and there were no signs of irritation at that time on either the intact or abraded sites.

 

In the second skin irritation study, test article was applied to intact and abraded skin of six albino rats and then covered with a semi-occlusive dressing. The dressing was removed after 24 hours. There were no signs of irritation at the 24 hour reading. The sites were read again and 72 hours and there were no signs of irritation at that time on either the intact or abraded sites.

In the first eye irritation study, an acute eye irritation/corrosion study was conducted on the test article. Six young adult albino rabbits were maintained for this study. 0.1 mL of the test article was instilled into the right eyes of the test animals while the other eyes remained untreated to serve as controls. The test article was not washed from the eyes. The treated eyes were examined at 1, 24, 48 and 72 hours as well as 5 and 7 days following instillation of the test material into the eyes. Irritation scores for all animals at all time points were found to be zero.

 

In the second eye irritation study, 0.1 mL of undiluted test article was instilled into the conjunctival sac of the right eye of each animal. The left eye of each animal was untreated, serving as a scoring control. At 24 hours any test article remaining in the eye was removed by rinsing the eye with distilled water. The eyes of the animals were examined at 1, 24, 48, 72, 96, and 168 hours after instillation of the test article and the irritation and description of local effects were recorded. Conjunctivae irritation scores of 2 were observed for all six animals at 1 hour after instillation but were completely resolved 24 hours after instillation. No corrosion, staining of ocular tissue, systemic toxicity or mortality was reported during the test period.

Please see IUCLID section 13 for the category justification and a matrix of irritation/corrosion data for members of the Perfluorinated Organic Chemicals C5-C18 category.

Justification for classification or non-classification

The test results do not meet the criteria for classification.