Registration Dossier
Registration Dossier
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EC number: 203-013-1 | CAS number: 102-20-5
Endpoint summary
Administrative data
Description of key information
Skin irritation: No skin irritation was observed in an OECD 439 guideline in-vitro study. This result is supported by 2 human patch studies also observing no irritating effects.
Eye irritation: The local effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405. No signs of irritation were observed on the treated eyes.
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
Key
This in vitro study was performed to assess the irritation potential of the test item means of the Human Skin Model Test (OECD 439). The test substance was tested in a purity of 99.9 %. The experiment was performed twice. Each three tissues of the human skin model EpiDerm™ were treated with the test item, the negative or the positive control for 60 minutes. 30 μL of the test item were applied to each tissue, and spread to match the surface of the tissue. After treatment with the test item the mean relative absorbance value was reduced irrelevantly to 96.6% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential. In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item is not irritant to skin.
Eye irritation
The local effect of the test item was investigated according to the method recommended in the OECD Guideline No. 405. Four female albino rabbits were exposed to 0.1 mL of the test article in one eye. The eyes were examined and the changes were graded according to a numerical scale one hour, 24, 48 and 72 hours after dosing. No signs of irritation were observed on the treated eyes. The following mean values, based on the results from the 24, 48 and 72 hour
readings, were calculated:
Cornea: 0
Iris: 0
Conjunctiva: 0
Chemosis: 0
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for skin and eye irritation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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