Registration Dossier
Registration Dossier
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EC number: 209-935-0 | CAS number: 598-50-5
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity testing of amines and amides combined with nitrite in Drosophila melanogaster.
- Author:
- Blijleven WGH.
- Year:
- 1 979
- Bibliographic source:
- Mutat. Res. 64, 128, abstract no. 43
Materials and methods
- Principles of method if other than guideline:
- Methylurea was administered to Berlin K males by feeding (either singly or in combination with NaNO2 and acetic acid) and the treated males were tested for sex-linked recessive lethals using standard procedures.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Methylurea
- EC Number:
- 209-935-0
- EC Name:
- Methylurea
- Cas Number:
- 598-50-5
- Molecular formula:
- C2H6N2O
- IUPAC Name:
- methylurea
- Details on test material:
- - Name of test material (as cited in study report): methylurea; no further data
Constituent 1
Test animals
- Species:
- Drosophila melanogaster
- Strain:
- other: Berlin K
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- - Vehicle(s)/solvent(s) used: no data
- Details on exposure:
- DIET
- either singly or in combination with NaNO2 and acetic acid - Duration of treatment / exposure:
- No data
- Frequency of treatment:
- Contineously
- Post exposure period:
- No data
Doses / concentrations
- Remarks:
- Doses / Concentrations:
No data
Basis:
- No. of animals per sex per dose:
- No data
- Control animals:
- other: methylurea alone
- Positive control(s):
- No data
Examinations
- Tissues and cell types examined:
- sex-linked recessive lethals
- Details of tissue and slide preparation:
- No data
- Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- positive
- Remarks:
- Methylurea, administered simultaneously with NaNO2 and acetic acid produced a highly significant increase in the frequency of sex-linked recessive lethals, relative to treatment with methylurea alone, when both NaNO2 and acetic acid were omitted.
- Toxicity:
- not specified
- Vehicle controls validity:
- not specified
- Negative controls validity:
- other:
- Positive controls validity:
- not valid
- Additional information on results:
- Nitrite is known to react with various amines and amides to yield carcinogenic and mutagenic N-nitroso compounds. It was suggested that under the acidic conditions prevailing in the human stomach, such nitrosation reactions may occur. The observed enhanced mutagenicity supports the assumption of possible development of mutagenic N-nitroso compounds after administration of methylurea combined with acidic conditions.
Applicant's summary and conclusion
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