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EC number: 201-368-7 | CAS number: 81-64-1
- 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:
- fertility, other
- Remarks:
- Examination of fertility parameters, rats
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 weeks
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Peer reviewed research document
Testing on methylhydroxyanthroquinone and considered good surrogate for read-across
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- Principles of method if other than guideline:
- Research included work on rats and mice.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- Performed in accordance with recognised methods as part of repeat-dose toxicity evaluation
Test material
- Reference substance name:
- 1,3,8-trihydroxy-6-methylanthraquinone
- EC Number:
- 208-258-8
- EC Name:
- 1,3,8-trihydroxy-6-methylanthraquinone
- Cas Number:
- 518-82-1
- Molecular formula:
- C15H10O5
- IUPAC Name:
- 6-methyl1,3,8-trihydroxyanthraquinone
Constituent 1
- Specific details on test material used for the study:
- Based on the herbal medicine Emodin
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals were quarantined for 11 days and were 6 weeks old on the first day of the studies.
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Groups of 10 male and 10 female rats and mice were fed diets containing 0, 312.5, 625, 1,250, 2,500, or 5,000 ppm emodin for 14 weeks.
Dietary concentrations in resulted in average daily doses of approximately 20, 40, 80, 170, and 340 mg/kg to males and females once weights were taken into account - Details on mating procedure:
- Not part of study - the test was aimed to look at effects on reproductive organs and sperm development
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 weeks
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 312.5 ppm (nominal)
- Dose / conc.:
- 1 250 ppm (nominal)
- Dose / conc.:
- 5 000 ppm (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, plain diet
- Details on study design:
- Note that the top dose was estimated to be approximately
Examinations
- Parental animals: Observations and examinations:
- Observed twice daily; animals were weighed initially, weekly, and at the end of the studies.
Clinical findings were recorded weekly.
Feed consumption was recorded weekly by cage.
Necropsy performed on all core study animals.
Organs weighed were heart, right kidney, liver, lungs, right testis, and thymus.
Blood was collected from the retroorbital sinus of special study male rats on days 5 and 22 and female rats on days 8 and 24 and from all core study rats surviving to the end of the studies for hematology and clinical chemistry analyses. - Oestrous cyclicity (parental animals):
- Vaginal samples were collected for up to 12 consecutive days prior to the end of the studies from females in all fgroups and evaluated for the relative frequency of estrous stages and for estrous cycle length.
- Sperm parameters (parental animals):
- At the end of the test, sperm samples were collected from males in all groups and evaluated for sperm count and motility.
The left testis, left epididymis and left cauda epididymis were weighed - Litter observations:
- Not applicable
- Postmortem examinations (parental animals):
- Full histopathology, including sexual organs
- Postmortem examinations (offspring):
- Not applicable
- Reproductive indices:
- Not applicable
- Offspring viability indices:
- Not applicable
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- All exposed groups of rats had an exposure concentration related body color change pattern from yellow to red.
This also coincided with discoloured bedding and was considered to be of no toxicological significance other than extretion of the test material or coloured metabolites were contaminating the animals - Mortality:
- mortality observed, non-treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Final mean body weights and body weight gains of males exposed to 2,500 ppm or greater and females exposed to 1,250 ppm or higher were significantly less than those of the controls
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- During the first week of the study, consumption of feed by males exposed to 2,500 or 5,000 ppm and females exposed to 5,000 ppm was less than that by the controls
- Food efficiency:
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- At the first blood extraction time point (day 5, males; day 8, females), there was evidence of a minimal treatment-related erythrocytosis in males exposed to 1,250 ppm or greater and in females exposed to 5,000 ppm but this was not observed at later time points.
- Clinical biochemistry findings:
- not specified
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Histologic lesions associated with emodin exposure were observed only in the kidney of males and females
These findings increased with increasing exposure concentration in the affected groups.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- The oestrous cycle length was significantly increased in females exposed to 1,250 or 5,000 ppm
- Reproductive function: sperm measures:
- no effects observed
- Description (incidence and severity):
- No significant differences in sperm motility between the exposed and control groups were observed.
- Reproductive performance:
- not examined
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEC
- Effect level:
- 312.5 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- LOAEC
- Effect level:
- ca. 20 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- histopathology: non-neoplastic
Target system / organ toxicity (P0)
open allclose all
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 312.5 ppm
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 20 mg/kg bw/day (nominal)
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- not measured/tested
- Remarks:
- Study aimed only to examine reproductive organs
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
Although the substance was well tolerated, effects were seen on female oestrus cycle at concentrations that led to material toxicity in other organs.
Effects to kidneys were seen at low concentrations.
No effect on male reproductive organs was see and the higher relative testes weight in the top group animals may have reflected a lower whole body weight in these animals.
Applicant's summary and conclusion
- Conclusions:
- Although the substance was well tolerated, effects were seen on female oestrus cycle at concentrations that led to material toxicity in other organs.
Effects to kidneys were seen at low concentrations.
No effect on male reproductive organs was see and the higher relative testes weight in the top group animals may have reflected a lower whole body weight in these animals. - Executive summary:
From this study, there appears to be no direct effect on the reproductive organs.
The substance is used in traditional medicines.
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