Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- 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:
- according to guideline
- Guideline:
- other: China National Health and Family Planning Commission, National Food Safety Standards: 90-day oral toxicity study, p. 13, 2015
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- not specified
- Limit test:
- no
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:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- 90 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 4 groups with 10 males and 10 females in each group
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Clinical signs and behavioral symptoms were recorded every day. Body weights were recorded weekly, and food consumption was recorded twice a week throughout the study. Ophthalmological examination was conducted before and at the end of the exposure-
- Sacrifice and pathology:
- Complete gross necropsy was conducted on all rats, absolute weight was measured, and relative organ weight (organ weight/body weight) was determined for the liver, spleen, kidneys, testes, ovaries, brain, heart thymus adrenal, epididymis, and uterus; histopathological examination, including the
brain, thyroid gland, liver, spleen, pancreatic gland, heart, kidneys, adrenal gland, stomach, mesenteric lymph nodes, small intestine, jejunum, ileum, prostate, bladder, testes, and ovaries.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The NOAEL of the water-extract sericin was determined to be > 1 g/kg/day.
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