Registration Dossier
Registration Dossier
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EC number: 209-935-0 | CAS number: 598-50-5
Endpoint summary
Administrative data
Description of key information
Skin: Rabbit in vivo, semiocclusive, clipped, 4 hours: not irritating (OECD 404, BASF AG 1986)
Eye: Rabbit in vivo (no washing out): not irritating (OECD 405, BASF AG 1986)
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
There are valid in vivo data available for the assessment of the skin and eye irritation potential of 1 -methylurea.
Skin irritation:
In a skin irritation study conducted by BASF (1986) according to the protocol of OECD 404 (1981), 1-methylurea (80 %) was applied to the clipped skin of 3 New Zealand White rabbits (2 males and 1 female) in a semiocclusive dressing for the exposure period of 4 hours. After 4 hours the test material was removed and the skin was washed. Very slight erythema was observed in a single rabbit at the 4-hour reading. No edema was observed in any animal at this time point. No signs of irritation were noted in any animal at the readings at 24, 48 and 72 hours. No other signs of intoxication were observed.
According to the test conditions, 1-methylurea was assessed to be not irritating to the skin.
Eye irritation:
In an eye irritation study performed by BASF 1986 according to OECD guideline 405 (1981), the 0.1 ml bulk volume (about 57 mg of the undiluted test substance) was applied to the eyes of New Zealand White rabbits (1 male and 2 females). The test substance was not washed out and induced mean scores of 0.0 to 0.67 for cornea opacity, 0.0 to 1.33 for conjunctiva redness, 0.0 for iris, and 0.0 to 0.33 for chemosis during the relevant reading period of 24 to 72 hours which were fully reversible within 72h. Small retractions in the eyelid of two rabbits were observed.
According to the test conditions, 1-methylurea was assessed to be not irritating to the eye.
Respiratory system:
There are no data available concerning the irritating potential to the respiratory system.
Conclusion: The test substance, 1 -methylurea, was not irritating to the skin and to the eye of rabbits.
Justification for classification or non-classification
Based on the results of the available skin irritation study, 1-methylurea has not to be classified for skin irritation according to directive 67/548/EEC and Regulation (EC) No. 1272/2008.
Based on the results of the available eye irritation study, 1-methylurea has not to be classified for eye irritation according directive 67/548/EEC and Regulation (EC) No. 1272/2008.
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