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EC number: 953-265-8 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1947
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity Studies on Rutin
- Author:
- Wilson RH
- Year:
- 1 947
- Bibliographic source:
- Proceedings of the Society for Experimental Biology and Medicine, 1947 64 : 3 , 324-327
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A reproductive toxicity test was conducted for the test item in Albino rats. After 150 days of treatment with 1% test item in diet, 6 males and 6 females, were mated after being caged together for a month
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Rutoside
- EC Number:
- 205-814-1
- EC Name:
- Rutoside
- Cas Number:
- 153-18-4
- Molecular formula:
- C27H30O16
- IUPAC Name:
- 2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-4-oxo-4H-chromen-3-yl 6-O-(6-deoxy-alpha-L-mannopyranosyl)-beta-D-glucopyranoside
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: about 90 g
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
1.0% (w/w) of the test item was thoroughly mixed into finely ground Purina Dog Chow. - Details on mating procedure:
- - M/F ratio per cage:1:1
- Length of cohabitation: 1 month - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 400 days
- Frequency of treatment:
- daily
- Details on study schedule:
- After 150 days of treatment, the 6 males and 6 females on the 1 % test item diet were caged together for a month and mated. Afterwards, they were observed periodically until they had been eating the diet for 400 days.
Doses / concentrations
- Dose / conc.:
- 1 other: % in diet
- No. of animals per sex per dose:
- 6 males and 6 females
- Control animals:
- yes, plain diet
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Cage side observations checked: mortality
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: Daily
FOOD CONSUMPTION AND COMPOUND INTAKE: No
WATER CONSUMPTION AND COMPOUND INTAKE: No - Oestrous cyclicity (parental animals):
- The length of the estrous cycle was measured
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: no
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
Number of pups, stillbirths, live births, postnatal mortality.
GROSS EXAMINATION OF DEAD PUPS: No
ASSESSMENT OF DEVELOPMENTAL NEUROTOXICITY: No
ASSESSMENT OF DEVELOPMENTAL IMMUNOTOXICITY: No - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals
GROSS NECROPSY
- Gross necropsy consisted of unspecified tissues
HISTOPATHOLOGY / ORGAN WEIGHTS
Tissues from all of the animals (both the 150-day and 400-day rats) were embedded in paraffin and sections were stained with hematoxylin and eosin. Histopathological study of these sections was made by Dr. A. J. Cox, Jr., Stanford University School of Medicine, San Francisco.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Endocrine findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The animals which received 1% test item in the diet for 400 days showed slight irregularity in vacuolation of the cortical cells of the adrenals, which may signify a little irregularity in lipoid content
of the cells. However, this was not pronounced and is of doubtful significance. In 3 of the 6 female rats which received the 1% test item diet there was distinctly more brown granular pigment in the renal epithelial cells than in the controls. However, since all of the control animals were males, this observation cannot be interpreted. The male rats receiving the same amount of test item did not show this change. - Histopathological findings: neoplastic:
- not examined
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Remarks on result:
- other: Equivalent to 500 mg/kg bw
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- One of the 4 litters was born dead
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 3 liiters were small (3 to 5 per litter)
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 other: % diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no significant effects observed
- Remarks on result:
- other: 500 mg/kg bw day
Target system / organ toxicity (F1)
- Key result
- Critical effects observed:
- no
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The reproductive toxicity assay of the test item in Albino rats has a NOAEL of 1% in diet for both sexes (500 mg/kg bw day).
- Executive summary:
A reproductive toxicity test was conducted for the test item in Albino rats. After 150 days of treatment with 1% test item in diet, 6 males and 6 females, were mated after being caged together for a month. 4 litters from 3 of the females were born and one of them was born dead and the other 3 were small (3 to 5 per litter). As no relevant effects were observed at the highest dose tested, the test item has a NOAEL of 1 % in diet in Albino rats for both sexes (500 mg/kg bw, conversion according to the guidelines for the preparation of working papers for the joint FAO/WHO expert committee on food additives).
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