Registration Dossier
Registration Dossier
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EC number: 209-935-0 | CAS number: 598-50-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Teratogenicity in rats and mice: NOAEL developmental toxicity ≥ 2000 mg/kg bw/day actual dose received; no maternal, embryotoxic and / or teratogenic effects (no guideline followed, Teramoto 1981)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Methylurea was tested for its developmental toxicity at the dose of 2000 mg/kg bw administered orally as a single dose by gavage of an aqueous solution to 15 weeks old Wistar rats (12 animals) on day 12 of pregnancy. On day 20 of pregnancy animals were killed. 1-methylurea had no observable effect on fetal development of rats. Fetal survival and weight of the group treated with this compound were comparable to those of the control group. Therefore, 1-Methylurea was not teratogenic in rats. A NOAEL of about ≥ 2000 mg/kg bw was determined.
In the same study, Methylurea was tested for its developmental toxicity at the dose of 2000 mg/kg bw administered orally as a single dose by gavage of an aqueous solutionto 8 weeks old ICR mice (10 animals) on day 10 of pregnancy. On day 18 of pregnancy animals were killed. 1-methylurea had no observable effect on fetal development in mice. Fetal survival and weight of the group treated with this compound were comparable to those of the control group. A NOAEL of about ≥ 2000 mg/kg bw was determined.
1-Methylurea was not teratogenic in either of the animal species. However, the studies are not reliable due to significant methodological deficiencies (single application, no guideline followed, small number of animals per group).
Justification for classification or non-classification
Based on the insufficient available data, the classification of 1 -methylurea for developmental toxicity according to directive 67/548/EEC and Regulation (EC) No. 1272/2008 is not possible.
Due to missing data, the classification of 1 -methylurea for reproduction toxicity according to directive 67/548/EEC and Regulation (EC) No. 1272/2008 is not possible.
Additional information
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