Registration Dossier

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.