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EC number: 222-429-4 | CAS number: 3468-63-1
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: The unusual study design, 78 week testament followed by a 20 week treatment free 'recovery period', the exclusion of animals which died pre-term as well as deficits in reporting make it impossible to assess the validity of the study results
Data source
Reference
- Reference Type:
- publication
- Title:
- Carcinogenicity Testing of the Cosmetic Dye: D&C Red No. 36
- Author:
- Kupradinun P, Rienkijakarn M, Tanyakaset M, Tepsuwan A, Kusarnran WR
- Year:
- 2 002
- Bibliographic source:
- Asian Pacific Journal of Cancer Prevention 3: 55-60,2002
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
Test material
- Reference substance name:
- 1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol
- EC Number:
- 220-562-2
- EC Name:
- 1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol
- Cas Number:
- 2814-77-9
- Molecular formula:
- C16H10ClN3O3
- IUPAC Name:
- 1-[(2-chloro-4-nitrophenyl)diazenyl]-2-naphthol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- 78 weeks
- Post exposure period:
- 20 weeks treatment free "recovery period"
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
1000 ppm
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
2000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, plain diet
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- The results of the present study thus demonstrated that C.I. Pigment Red 4 (=D&C Red No. 36) at the concentrations of 1,000 ppm and 2,000 ppm in the diet is not carcinogenic either to male or female Wistar rats.
- Executive summary:
In this study groups of 50 male and 50 female Wistar rats were administered D&C Red No. 36 (Warner Jenkinson Company, NJ, USA; Purity > 95%) at dietary dose levels of 0, 1000, and 2000 ppm for 78 weeks (estimated daily dose: 50 and 100 mg/kg b.w.). At week 98 all surviving animals were killed and various organs were sampled and stored in formalin. The organs sampled included at least lung, liver, spleen, kidney, urinary bladder, mammary gland and thyroid gland. Survival of rats was not affected by treatment. The number of survivors at termination (week 98) was 50, 48 and 48 in males and 50, 47, and 50 in females at 0, 1000, and 2000 ppm, respectively. The 7 animals which died were excluded from evaluation since they died before week 40. Body weight development was not affected in males but slightly, but statistically significant lower in treated females when compared to the control. Besides body weight data no information is available to assess the systemic toxicity caused by PR4 and thus obtain an indication on the bioavailability of the pigment.
Tumor incidences were reported for liver, thyroid, adrenals, urinary bladder, and mammary gland (Table 4). The incidence of benign tumors was low (£4%) in most tissues and not indicative of a treatment-related effect. Higher tumor incidences were only observed in the liver and mammary gland. The mammary tumor incidence in females and of liver tumors in males was not indicative of an adverse effect. In females the incidence of “liver tumors' was dose-dependently increased (Please note: the incidences reported also include hyperplastic nodules!). This increase was however not statistically significant. The incidence of malignant tumors was likewise low and did not indicate a relation to treatment.
Based on the data presented the authors conclusion was: “The results of the present study thus demonstrated that D&C Red No. 36 at the concentrations of 1,000 ppm and 2,000 ppm in the diet is not carcinogenic either to male or female Wistar rats. While the occurrence of benign liver tumors in female rats may be related to dye treatment, the lack of any apparent dose-dependence or any statistically significant difference from the control group (P = 0.06) suggests that this is unlikely.”
A treatment-related increase of her tumors in females is questionable since a) various types of her tumors and pre-neoplastic lesions were lumped together and b) the historical background of liver tumors in the strain of rats used in that laboratory is not known.
Furthermore, the unusual study design, 78 week testament followed by a 20 week treatment free 'recovery period', the exclusion of animals which died pre-term as well as deficits in reporting make it impossible to assess the validity of the study results.
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