Registration Dossier

Administrative data

Description of key information

Skin corrosion: In view of the absence of skin and eye irritation the substance is not corrosive

Skin irritation: in vitro test (OECD 439): not irritating

Eye irritation: in vitro test (OECD 438): not irritating

Respiratory irritation: Not a respiratory irritant (based on absence of human data indicating such and absence of skin and eye irritation)

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 adverse effect observed (not irritating)

Additional information

Skin corrosion: In view of the absence of skin and eye irritation the substance is not corrosive

Skin irritation

In accordance to OECD guideline 439 and GLP the test substance was examined for its in vitro skin irritation potential using EpiDerm™ reconstructed skin membranes. In the in vitro skin irritation test, the skin membranes were topically exposed to the undiluted test substance for 60 min. The test was performed in triplicate. Viability of the epidermal cells was assessed using the MTT test after 42 h of culture. Negative and positive controls were run in parallel. All acceptance criteria were met and therefore the study was considered valid. After exposure to the test substance the mean tissue viability was 105 ± 11 % compared to the concurrent negative control group. Based on the results obtained in the present study the test substance is not considered to be a skin irritant.

 

Eye irritation

In accordance to OECD guideline 438 and GLP the test substance was examined for its in vitro eye irritating potential using the Isolated Chicken Eye (ICE) Test. In the ICE test, 3 eyes were exposed to 30 µL test substance for 10 seconds. In addition, one negative control eye (30 µL saline) and three positive control eyes (30 µL Benzalkonium Chloride (BAC)) were tested. After the exposure the eyes were rinsed with 20 mL saline and were examined at approximately 0, 30, 75, 120, 180, and 240 minutes after treatment. The test substance caused very slight corneal swelling (4%), very slight or slight opacity (mean score of 0.7) and no fluorescein retention (mean score of 0.0). The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control BAC 5% caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the corneas treated with Pinyl Iso Butyraldehyde revealed very slight erosion (two corneas) and slight necrosis (one cornea) of the epithelium. Microscopic examination of the cornea treated with the negative control (saline) did not reveal any abnormalities, apart from very slight vacuolation (top region) of the epithelium. The positive control BAC 5% caused moderate or severe erosion, slight vacuolation (one cornea; low region) of the epithelium, and endothelial necrosis. Based on these results the test substance is not considered to be an eye irritant.

 

Respiratory irritation

Not a respiratory irritant (based on absence of human data indicating such and absence of skin and eye irritation).

Justification for classification or non-classification

Based on the available information the test substance does not need to be classified for skin, eye and respiratory irritation in accordance with the criteria outlined in EU CLP (EC no. 1272/2008 and its amendments).