Registration Dossier
Registration Dossier
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EC number: 209-566-5 | CAS number: 585-86-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity Studies of Lactitol (NS-4)
- Author:
- Iwakura K, Tamura H, Watanabe M, and Sumi N
- Year:
- 1 994
- Bibliographic source:
- J Tox Sci, 19(Suppl. III):487–497
Materials and methods
- Principles of method if other than guideline:
- An in vivo micronucleus test in male mice was performed.
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- EC Number:
- 209-566-5
- EC Name:
- 4-O-β-D-galactopyranosyl-D-glucitol
- Cas Number:
- 585-86-4
- Molecular formula:
- C12H24O11
- IUPAC Name:
- 4-O-beta-D-galactopyranosyl-D-glucitol
Constituent 1
- Specific details on test material used for the study:
- - NS-4
- Lot No.12
Test animals
- Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- Single dose
- Frequency of treatment:
- Single dose
- Post exposure period:
- 24, 48, and 72 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 2 000 mg/kg diet
- Dose / conc.:
- 1 000 mg/kg diet
- Dose / conc.:
- 500 mg/kg diet
- Dose / conc.:
- 250 mg/kg diet
- No. of animals per sex per dose:
- 6/dose/time point
- Control animals:
- yes
- Positive control(s):
- The dose of MMC (the positive control) administered was set to 2 mg/kg, and the group to which it was administered was regarded as the 24 hour sample group.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- The test substance was negative in the mouse micronucleus test.
- Executive summary:
Lactitol (NS-4) was examined for mutagenicity in the micronucleus test in mice. In the micronucleus test with ddY male mice, the drug did not significantly increase micronucleated polychromatic erythrocytes in the bone marrows. This result suggests that lactitol has no mutagenicity in vivo.
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