Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 226-939-8 | CAS number: 5567-15-7
- 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
Carcinogenicity
Administrative data
Description of key information
The „Laboratorium für Pharmakologie und Toxikologie“ performed carcinogenicity tests with Pigment Yellow 83 using NMRI mice and Sprague Dawley rats. In two parallel experiments the animals received up to 9000 ppm Pigment Yellow 83 which was intentionally contaminated with 20 ppm 3,3‘-dichlorobenzidine. No carcinogenic effects were observed in any of these tests.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From JAN 1974 to APR 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: S. IVANOVAS GmbH & Co, Med. Versuchstierzucht KG (Kissleg, Germany)
- Age at study initiation: 26 (males) -27 (females) days
- Weight at study initiation: 18.1 - 20.1 g
- Housing: individually in Macrolon cages (Type I)
- Diet: Altromin 1321 (Altromin, Lage), ad libitum
- Water: tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 +/- 0.5
- Humidity (%): 60 +/- 3
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- daily
- Post exposure period:
- none
- Dose / conc.:
- 1 000 other: ppm in diet
- Dose / conc.:
- 3 000 other: ppm in diet
- Dose / conc.:
- 9 000 other: ppm in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
- Positive control:
- none
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice per day
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: daily
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: once, immediately before sacrifice
- Dose groups that were examined: all animals
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER:
at the end of the exposure period the following investigations were performed:
- audiometry (simple sound test)
- inspection of denture
- organ weights from 7-8 organs (heart, liver, lungs, spleen, kidney, thymus, brain, testis) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (animals of the control and highest dose group; paraffin sections, Haematoxylin-Eosin staining):
heart, lung, liver (additionally sections with Sudan staining), kidney, spleen, adrenal, thymus, pituitary, brain, gonads, thyroid, prostate, uterus, seminal vesicle, mammary gland, stomach, duodenum, colon, salivary gland, lymph nodes, eye and optic nerve, urinary bladder, bone marrow, neoplastic lesions, bones
- histopathological investigations of animals of the lower dose groups were performed, if they died or were sacrificed in the meantime and revealed macroscopic findings - Statistics:
- - variance analysis according to Peto
- Student's t-test - 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:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- 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
- Relevance of carcinogenic effects / potential:
- A chronic carcinogenicity study with the submission substance has been performed, which is basically in accordance with existing guidelines. The results of this study are relevant for the evaluation of the carcinogenic properties of the submission substance.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 9 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no substance related toxicity or carcinogenicity was observed; 9000 mg/kg diet (ppm) correspond to 1935.8 mg/kg bw/day and 1961.3 mg/kg bw/day in male and female mice, respectively (calculated in the study report on basis of food consumption)
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Key result
- Critical effects observed:
- no
- Conclusions:
- Chronic feeding of NMRI mice with up to 9000 ppm of the test item in diet (corresponding to 1935.8 mg/kg bw/day and 1961.3mg/kg bw/day in male and female mice, respectively) did not result in an increased tumour incidence, indicating that the test item is not carcinogenic.
- Executive summary:
NMRI mice (50 per sex per dose) were exposed to 1000, 3000, 9000 ppm of the test item in diet (corresponding to 213, 652, 1936 mg/kg bw/day and 210, 642, 1961 mg/kg bw/day in male and female mice, respectively) for 104 weeks. The test item did neither induce toxicity nor tumorigenicity in the tested dose range.
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From JAN 1974 to APR 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 451 (Carcinogenicity Studies)
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- daily
- Post exposure period:
- none
- Dose / conc.:
- 1 000 other: ppm in diet
- Dose / conc.:
- 3 000 other: ppm in diet
- Dose / conc.:
- 9 000 other: ppm in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
- Relevance of carcinogenic effects / potential:
- The study design is basically in accordance with existing guidelines. Therefore, the results are considered relevant for the evaluation of the carcinogenic potential of the test item.
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 9 000 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no substance related toxicity or carcinogenicity was observed; 9000 mg/kg diet (ppm) correspond to 591.9 mg/kg bw/day and 632.3 mg/kg bw/day in male and female rats, respectively (calculated in the study report on basis of food consumption)
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Key result
- Critical effects observed:
- no
- Conclusions:
- Chronic feeding of Sprague Dawley rats with up to 9000 ppm of the test item in diet (corresponding to 591.9 mg/kg bw/da and 632.3 mg/kg bw/day in male and female rats, respectively), which was contaminated with 20 ppm 3,3'-dichlorobenzidine, did not result in an increased tumour incidence, indicating that the test item is not carcinogenic. These results are in accordance with the findings of the key study.
- Executive summary:
Sprague Dawley rats were exposed to 1000, 3000, 9000 ppm of the test item in diet (corresponding to 68, 203, 592 mg/kg bw/day and 68, 201, 632 mg/kg bw/day in male and female rats, respectively) for 104 weeks. The test item did neither induce toxicity nor tumorigenicity.
Referenceopen allclose all
- no effects on behaviour, appearance, faeces, feed and drinking water uptake, eyes, hearing, dentition, mortality, body weight development
- no substance induced macroscopic or histological changes
- no substance related effects on the tumour incidence (overall tumor rate: 33%, 23%, 19%, 26% in the control, 1000 ppm, 3000 ppm and 9000 ppm dose group, respectively; males: 32%, 22%, 18%, 16%, females: 34%, 24%, 20%, 36% in the control, 1000 ppm, 3000 ppm and 9000 ppm dose group, respectively)
- 1000, 3000, 9000 ppm in diet correspond to 213, 652, 1936 mg/kg bw/day in male and 210, 642, 1961 mg/kg bw/day in female mice, respectively
- no effects on behaviour, appearance, faeces, feed and drinking water uptake, eyes, hearing, dentition, mortality, body weight development
- no substance induced macroscopic or histological changes
- no substance related effects on the tumour incidence (overall tumor rate: 43%, 42%, 30%, 47% in the control, 1000 ppm, 3000 ppm and 9000 ppm dose group, respectively; males: 52%, 46%, 36%, 52%, females: 34%, 38%, 24%, 42% in the control, 1000 ppm, 3000 ppm and 9000 ppm dose group, respectively)
- 1000, 3000, 9000 ppm in diet correspond to 68, 203, 592 mg/kg bw/day in male and 68, 201, 632 mg/kg bw/day in female rats, respectively
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 935 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- reliable
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
There is no evidence for species specific effects of the substance. Therefore, the results of the in vitro/in vivo data are regarded as relevant for humans.
Justification for classification or non-classification
Due to the negative findings in reliable studies on carcinogenicity of Pigment Yellow 83 in rats and mice it is not classified as carcinogenic according to Regulation (EC) No 1272/2008.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.