Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
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
- Study period:
- 2020
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety Assessment of Water-Extract Sericin from Silkworm (Bombyx mori) Cocoons Using Different Model Approaches
- Author:
- Huiyan Qin
- Year:
- 2 020
- Bibliographic source:
- Hindawi, BioMed Research International, Volume 2020, Article ID 9689386
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- other: China National Health and Family Planning Commission, National Food Safety Standards: chromosome aberration test of mammalian bone marrow cells, p. 6, 2014.
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Sericin Bombyx mori (silkworm)
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Sericin Bombyx mori (silkworm)
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Kunming
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- 48 hours
- Frequency of treatment:
- twice with a 24 h interval
- Post exposure period:
- 6 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 6 660 mg/kg bw/day (nominal)
- Dose / conc.:
- 3 330 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 665 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 groups with 5 males and 5 females in each group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- yes, 40 mg/kg cyclophosphamide
Examinations
- Tissues and cell types examined:
- erythrocytes
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Sericin extract was nonmutagenic in the in vivo mammalian erythrocyte micronucleus test.
- Executive summary:
The micronucleus rate and PCEs/RBCs of mice were not affected by sericin extract, when compared to the negative control. Sericin extract was therefore nonmutagenic in the in vivo mammalian erythrocyte micronucleus test.
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