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Registration Dossier
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EC number: 207-542-9 | CAS number: 480-16-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 weeks
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to national standards: Guidelines for Designation for Food Additives and for Revision of Standards for Use of Food Additives of Japan (1996)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines for Designation for Food Additives and for Revision of Standards for Use of Food Additives of Japan (1996)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2',3,4',5,7-pentahydroxyflavone
- EC Number:
- 207-542-9
- EC Name:
- 2',3,4',5,7-pentahydroxyflavone
- Cas Number:
- 480-16-0
- Molecular formula:
- C15H10O7
- IUPAC Name:
- 2',3,4',5,7-pentahydroxyflavone
- Reference substance name:
- Morin
- IUPAC Name:
- Morin
- Reference substance name:
- structure
- IUPAC Name:
- structure
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- >95% (w/w), which was extracted from branch, trunk and root parts of Broussonetia xanthoxylum MARTIUS
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Fischer 344/DuCrj
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0 %
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0.625 %
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1.25 %
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
2.5 %
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
5 %
Basis:
nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 299 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- NOAEL
- Effect level:
- 356 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOEL = 299 mg/kg bw/day; NOAEL = 356 mg/kg bw/day.
- Executive summary:
Groups of 10 male and 10 female Fischer 344/DuCrj rats received 0 %, 0.625 %, 1.25 % , 2.5 % or 5.0 % (w/w) morin with dietary for 13 weeks. Especially in the higher dose groups food consumption was higher than expected, resulting in a higher than expected intake of Morin (males: 0, 299, 613, 1350, 3485 mg/kg/day; females: 0, 356, 712, 1701, 3802 mg/kg/day). No mortality in any of the tested groups was observed. Even in the highest dose group no deterioration of the general conditions could be monitored. For the male rats significant increases in ALT (over 2.5%), ALP (1.25% and 5.0%) and relative liver weights (1.25% and 2.5%) were observed. For the female rats significant increases in c-GT (over 2.5 %), AST (over 2.5 %), ALT (over 2.5 %), relative liver weights (over 2.5 %), ALP (5 %), BUN (over 1.25 %) and Cre (5.0%) were observed. The dose group0.625 % did not show any changes compared to the control group for both sexes. That concludes in the estimation of the NOEL and NOAEL at 299 and 356 mg/kg/day, respectively.
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