Registration Dossier
Registration Dossier
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EC number: 229-846-0 | CAS number: 6784-13-0
Endpoint summary
Administrative data
Description of key information
Skin irritation: Not irritating based on an OECD TG 404 test.
Eye irritation: Not irritating based on an OECD TG 438 test.
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
Skin irritation: The study was performed to assess the irritancy potential of the test substance following single, 3-minute, 1 and 4-hour, semi-occluded applications to the intact rabbit skin according to the OECD Guideline 404 in compliance with GLP. No corrosive effects noted after the 3-minute and 1-hour semi-occluded applications of test material to intact skin of one rabbit. A single 4 hour semi-occluded application of test material to the intact skin of 3 rabbits resulted in well-defined erythema and very slight to slight edema. The mean erythema and oedema scores over 24, 48 and 72 hours were 1 and 0 for one rabbit and 2 and 1 for other two rabbits. In all cases, erythema was reversible within 14 days and oedema was reversible within 7 days in all the animals. Other skin reactions were a light brown discoloration of the epidermis, desquamation and loss of skin elasticity. One treated skin site appeared normal at the 14-day observation. Desquamation is seen at day 7 with erythema in 2/3 animals. At day 14 only some desquamation is seen, without inflammation. Therefore, the substance does not need to be classified for skin irritation.
Eye irritation: An Isolated Chicken Eye Test (ICET) was performed with the substance according to OECD guideline 438 and in accordance with GLP principles. Thirty µL of the substance was applied to corneas (n=3). After 10 seconds exposure time, the surface of the eyes was rinsed with physiological saline solution. No significant corneal swelling change (mean = 1.2) was observed during the four-hour observation period on test item treated eyes. No cornea opacity and no fluorescein retention change were observed on the test item treated eyes. No other corneal effect was observed Based on the results, the Corneal opacity, Corneal swelling and Fluorescein retention endpoints were assigned ICE CLASS I. Therefore, the substance is considered as non-irritant.
Justification for classification or non-classification
Based on the results of the available in vitro skin and eye studies, the substance does not need to be classified for skin and eye irritation according to EU CLP (EC 1272/2008 and its amendments).
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