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EC number: 435-990-7 | CAS number: 371921-34-5
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 6 to April 3, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- 1996
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1995
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines for Screening, Toxicity Testing of Chemicals: Testing Methods for New Substances, enacted July 13, 1974, amended December 5, 1986
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Yellow 981
- IUPAC Name:
- Yellow 981
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Mean measured concentrations of homogeneity samples were 99.8 %, 94.9 % and 93.6 % of the nominal concentrations of homogeneity samples (10, 40 and 200 mg/ml, respectively). Individual concentrations were within -2 % to +1 % of mean concentrations. The test item is therefore homogeneousy distributed in the vehicle.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- 28 days of administration
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- 28 days of administration + 14-day recovery period
- Dose / conc.:
- 50 mg/kg bw/day (actual dose received)
- Remarks:
- 28 days of administration
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Remarks:
- 28 days of administration
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- 28 days of administration
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- 28 days of administration + 14-day recovery period
- No. of animals per sex per dose:
- 5 male and 5 female animals per group
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Mortality (daily), clinical signs (daily), functional observation battery (during week 4), food consumption (weekly), body weight (weekly), haematology (immediately prior to sacrifice), biochemistry (immediately prior to sacrifice), urinalysis (18-hour fasting period immediately prior to sacrifice)
- Sacrifice and pathology:
- Organ weights, macroscopic and microscopic findings
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- - Bright orange faeces (day 2 onwards; 200 and 1000 mg/kg bw/day groups only; first two days of recovery period only)
- Slight salivation (1 female administered 1000 mg/kg bw/day, day 24 only; isolated finding)
- Miosis (1 control male during pretest only; considered temporary) - Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - Signs of anaemia: reduced mean RBC and Hb, increased mean cell volume and cell Hb (males and females administered 1000 mg/kg bw/day); decreased mean cell [Hb] (females adminsitered 1000 mg/kg bw/day)
- Signs of compensatory reticulocytosis: increased absolute and mean reticulocyte count (males and females administered 200 and 1000 mg/kg bw/day); left shift toward high fluorescence reticulocytes (males and females administered 200 and 1000 mg/kg bw/day); increased normoblast count (females administered 200 and 1000 mg/kg bw/day; statistically significant at 1000 mg/kg bw/day only)
- Signs of compensatory reaction to anaemia: abnormal RBC morphology (polychromatophilia) (males and females administered 1000 mg/kg bw/day and females administered 200 mg/kg bw/day)
- Recovery group: unaffected by test item - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- - Elevated total bilirubin (males and females administered 1000 mg/kg bw/day, and females administered 200 mg/kg bw/day)
- Reduced globulin (males and females administered 1000 mg/kg bw/day) and concomitant increased albumin:globulin ratio
- Increased phosphorus and sodium (females administered 1000 mg/kg bw/day)
- Lower urea (treated males; incidental; high control value)
- Elevated urea (females administered 200 mg/kg bw/day; not dose-dependent; incidental)
- Recovery group: elevated total bilirubin persisted (females only) - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - Decreased mean specific gravity (males administered 1000 mg/kg bw/day; incidental and reversible in recovery period)
- Behaviour (functional findings):
- effects observed, non-treatment-related
- Description (incidence and severity):
- - Salivation (1 control male + 1 female administered 50 mg/kg bw/day; incidental)
- Grip strength significantly increased (males administered 200 and 1000 mg/kg bw/day; forelimbs only; incidental)
- Locomotor activity significantly decreased (females administered 1000 mg/kg bw/day; not test item related); other locomotor activity differences were considered not dose-related and incidental - Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- - Increased relative and absolute spleen weights (males and females administered 1000 mg/kg bw/day; also in those administered 200 mg/kg bw/day but not statistically significant)
- Increased liver:bw ratio (females administered 50 and 1000 mg/kg bw/day only; incidental among those administered 50 mg/kg bw/day only)
- Recovery group: spleen and liver weight differences reversed (males and females); decreased absolute and relative thymus and ovary weights (females administered 1000 mg/kg bw/day; incidental) - Gross pathological findings:
- effects observed, non-treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- - Minimal extramedullary haematopoiesis of liver (1 female administered 200 mg/kg bw/day and 1 male administered 1000 mg/kg bw/day)
- Slightly increased erythropoiesis of speen (males and females administered 1000 mg/kg bw/day and 3 males and 2 females administered 200 mg/kg bw/day)
- Recovery group: no significant findings - Details on results:
- Oral administration to rats at doses of 50, 200 and 1000 mg/kg/day for 28 days resulted in no effects upon mortality, daily clinical observations, weekly behiavioural observations, functional observational battery, food consumption, body weight or urinalysis parameters.
Treatment-related findings were generally restricted to rats treated with 200 or 1000 mg/kg/day.
Changes were seen in hematology parameters (reduced mean red blood cell count, reduced mean hemoglobin levels, increased mean cell volume and increased mean cell hemoglobin in both sexes and reduced mean cell hemoglobin concentration in females, increased reticulocytes counts with 'left-shift', increased normoblast counts and polychromatophilia) and clinical biochemistry parameters (increased total bilirubin in both sexes, reduced globulin levels, increased albumin/globulin ratios, increased phosphorus and sodium in females), which were generally indicative of anemia with compensatory reticulocytosis and bone marrow stimulus.
These changes were reflected also in the results of histopathology, whereby increased erythropoiesis was noted in the spleen of one female treated at 200 mg/kg/day, and extramedullary hepatic erythropoiesis (generally associated with splenic findings) in the livers of one female treated at 200 mg/kg/day and in one male and three females treated with 1000 mg/kg/day.
No test item-related histopathologic findings were noted in rats following the 14-day recovery period.
After the recovery period, hematology parameters in males of males treated at 1000 mg/kg(day were considered to be unaffected by test item; the elevated lymphocyte count and prolonged activated partial thromboplastin time were considered to be incidental.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- haematology
- histopathology: non-neoplastic
- Dose descriptor:
- LOAEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- haematology
- histopathology: non-neoplastic
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- NOAEL (sub-acute, rat, oral) = 50 mg/kg bw/day
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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