Registration Dossier
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EC number: 221-424-4 | CAS number: 3089-17-6
- 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 31 AUG 2004 to 7 FEB 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study (OECD TG 407)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Guidelines for Screening, Toxicity Testing of Chemicals: testing Methods for new Substances (1986)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 938065-79-3
- Cas Number:
- 938065-79-3
- IUPAC Name:
- 938065-79-3
- Reference substance name:
- 909-082-0
- EC Number:
- 909-082-0
- IUPAC Name:
- 909-082-0
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- HanBrl:WIST (SPF)
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: 7 weeks
- Weight range (and mean) at acclimatization: Males 141-154 g (mean 147.9); Females 119- 134 g (mean: 126.1 g)
- Housing: in groups of 5 in macrolon cages (type 4)
- Diet: Provimi Kliba 3433 rat maintenance diet (batch nos. 34/04, 42/04, 53/04; Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: community tap-water from Itingen (Switzerland), ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30 to 70
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- dose formulations were prepared daily at room temperature and homogeneity was kept using a magnetic stirrer.
- the test item is stable in dose formulations for up to 7 days
VEHICLE
- polyethylene glycol 300 - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration, homogeneity and stability (after 2 hours and 7 days) of the dose formulations were determined in samples taken after experimental start. Concentration and homogeneity of the dose formulations were determined in samples taken during week 3 of the treatment.
Analysis was performed spectrophotometrically by UUV/VIS-detection at 530 nm by RCC Ltd according to amethod provided by the sponsor. - Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 200, 1000 mg/kg bw/d
Basis:
actual ingested
- No. of animals per sex per dose:
- - 5 male and 5 female in each dose group
- 5 male and 5 female for recovery groups at dose 0 and 1000 mg/ kg bw/day - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on the results of a dose range finding study with the test item (5 days oral exposure of male and female rats to 200, 600 and 1000 mg/kg bw/day did not cause changes in clinical appearance, body weights, food consumption, organ weights and macroscopic examination (only in one female control animal there was pelvic dilatation in the kidney on the left side) and all animals survived until scheduled necropsy)
- Post-exposure recovery period in satellite groups: the duration of recovery was 14 days - Positive control:
- - none
Examinations
- Observations and examinations performed and frequency:
- MORTALITY/VIABILITY: Yes
- twice daily
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once before treatment, twice daily on days 1-3, once daily on days 4-28 and once daily during days 29-42 (recovery)
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once before treatment and thereafter once weekly
BODY WEIGHT: Yes, weekly
FOOD CONSUMPTION: yes, weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
HAEMATOLOGY: Yes
- Parameters checked see below in Hematology
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks and after 6 weeks (the latter only applied for recovery groups)
- Animals fasted: Yes (appr. 18 hours before blood collection)
- How many animals: all animals
- Parameters checked see below
URINALYSIS: Yes
- Time schedule for collection of urine: after 4 weeks and after 6 weeks (the latter only applied for recovery groups)
- Metabolism cages used for collection of urine: No (urine was collected during the 18-hour fasting period into a specimen vial)
- Animals fasted: Yes
- Parameters checked see below
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: during week 4
- Dose groups that were examined: all
- Battery of functions tested: grip strength / locomotor activity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (parameters checked see below)
HISTOPATHOLOGY: Yes (parameters checked see below) - Statistics:
- - Dunnett-test
- Fisher's exact test (applied on macroscopic findings)
- clinical laboratory data were analysed via ANOVA according to Bartlett or non-parametric Kruskal-Wallis test, treated groups were compared to control groups using ANOVA and Dunnett's test or combining Kruskal-Wallis test with the Dunn's test
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
- no deaths occurred during the test
- two males treated with 1000 mg/kg/day presented a temporary hair loss during week 2 of treatment with the test item
- one female showed respiratory rales during two days of treatment with the test item
- dark red feces were noted in animals treated with the test item ("grade 1" in animlas treated with 50 or 200 mg/kg/day; "grade 2" in animals treated with 1000 mg/kg/day), which stopped at the termination of the treatment
- overall no clinical observations of toxicological relevance were found
BODY WEIGHT AND WEIGHT GAIN
No test item-related changes of toxicological relevance were noted in the mean body weights and body weight gain, at any dose level, when compared with controls, after four weeks of treatment and after recovery.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
The mean daily food consumption and the relative food consumption of the test item-treated males and females compared favorably with their respective controls during the treatment and the recovery periods.
CLINICAL LABORATORY INVESTIGATOIONS
-HAEMATOLOGY
No changes of toxicological relevance were observed in the hematology parameters after the treatment or recovery periods in both males and females.
-CLINICAL CHEMISTRY
No changes of toxicological relevance were noted in the clinical biochiemistry parameters after the treatment and the recovery periods.
-URINALYSIS
No changes of toxicological relevance were observed in the urinalysis parameters after the treatment with the test item and the recovery period in both males and females, at any dose level tested.
ORGAN WEIGHTS
No test item related differences in the mean absolute or relative organ weights were noted after four weeks' treatment or after two weeks' recovery in males or female rats of any dose level.
GROSS PATHOLOGY
- The pink coloured and birefringent granules were recorded in the lumen of the gastrointestinal tract of most animals of the high dose group (1000 mg/kg/d). Without any tissue reaction these particles were regarded to present residues of the adminsitered test item. At the end of the recovery period the material was no longer present.
HISTORICAL CONTROL DATA (if applicable)
- all microscopic findings recorded did not distinguish significantly treated rats from control rats and were considered to be spontaneous in nature and within the normal background pathology commonly seen in rats of this strain and age.
OTHER FINDINGS
-transitory increase in the mean locomotor activity was observed in males and females treated with 1000 mg/kg/d during one measurement interval. In the absence of a clear dose-response relationship, these changes were considered as incidental.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: no clinical signs; no mortality; body weight development was not impaired; food consumption was not affected; no findings in haematology; no effects found in clinical chemistry, urinalysis, gross pathology and histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no changes in clinical appearance, functional observations, body weights, food consumption, clinical laboratory investigations, macroscopic examination, organ weights and microscopic examination that were considered to be an effect of treatment.
From the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for PIGMENT RED 282 of 1000 mg/kg/day was established. - Executive summary:
A 28 -day repeated dose toxicity study with PIGMENT RED 282 administered by oral gavage to Wistar rats (SPF-bred; 5/sex/dose) was performed according to OECD TG 407. The dose levels for this study were 50, 200 and 1000 mg/kg bw/day. A control group was treated similarly with the vehicle, PEG 300, only. The dosing lasted for 28 days and a 14 day recovery group for controls and the high dosage group (1000 mg/kg bw/d) was included. The test item revealed no treatment-related findings. From the results presented in this report a definitive No Observed Adverse Effect Level(NOAEL) for the test item of 1000 mg/kg bw/day was established.
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