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Diss Factsheets
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EC number: 939-292-8 | 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- other: read across from analogue substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: full study is available; only summary inserted
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 010
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- In a developmental toxicity study, groups of 35 pregnant rats were fed Brown FK at dietary concentrations of 0, 0.03, 0.15, or 0.6 % (equivalent to 0, 15, 75, or 300 mg/kg bw/day) from day 0-19 days
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Similar Substance 4
- IUPAC Name:
- Similar Substance 4
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Details on exposure:
- daily
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 0-19 of pregnancy
- Frequency of treatment:
- daily
- Duration of test:
- 21 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 15 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 75 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 35 pregnant females per each dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- In a developmental toxicity study, groups of 35 pregnant rats were fed Brown FK at dietary concentrations of 0, 0.03, 0.15, or 0.6 % (equivalent to 0, 15, 75, or 300 mg/kg bw/day) from day 0-19 post coitus. Additional groups received 0.6% sodium chloride (salt control) or aspirin (250 mg/kg bw/day) (positive control). Five animals at each dose level were allowed to litter normally and the offspring were raised to weaning, while the remaining animals in each group were sacrificed at Gestation Day (GD) 17 and the fetuses removed by Caesarean section. Two-thirds of the fetuses were examined for gross soft-tissue abnormalities, then cleared and stained with Alizarin red for examination for skeletal defects. The remaining one-third of animals was examined for soft tissue defects
Examinations
- Maternal examinations:
- No abnormalities in condition or behaviour of the dams were observed.
- Fetal examinations:
- Soft tissue abnormalities or skeletal defects were not observed in any of the sacrificed fetuses or weaned animals
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- mortality
Results (fetuses)
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- skeletal malformations
- visceral malformations
Overall developmental toxicity
- Developmental effects observed:
- no
- Lowest effective dose / conc.:
- 300 mg/kg bw/day (actual dose received)
Applicant's summary and conclusion
- Conclusions:
- The analogue substance was tested following a study desgin equivalent to OECD 414. Under the experimental conditions the NOAEL is equal to 300 mg/kg bw /day.
- Executive summary:
In a developmental toxicity study, groups of 35 pregnant rats were fed Brown FK at dietary concentrations of 0, 0.03, 0.15, or 0.6 % (equivalent to 0, 15, 75, or 300 mg/kg bw/day) from day 0-19
post coitus. Additional groups received 0.6% sodium chloride (salt control) or aspirin (250 mg/kg bw/day) (positive control). Five animals at each dose level were allowed to litter normally and the
offspring were raised to weaning, while the remaining animals in each group were sacrificed at Gestation Day (GD) 17 and the fetuses removed by Caesarean section. Two-thirds of the fetuses were
defects. Soft tissue abnormalities or skeletal defects were not observed in any of the sacrificed fetuses or weaned animals examined for gross soft-tissue abnormalities, then cleared and stained with Alizarin red for examination for skeletal defects. The remaining one-third of animals was examined for soft tissue
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