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EC number: 277-459-0 | CAS number: 73398-89-7
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- Biodynamics Incorporation
- Year:
- 1 992
- Bibliographic source:
- NTRL
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- A Three-month Dose Range-Finding Study of test chemical in Mice was conducted to evalute its toxic nature.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- EC Number:
- 201-383-9
- EC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- Cas Number:
- 81-88-9
- Molecular formula:
- C28H31N2O3.Cl
- IUPAC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthenium chloride
- Reference substance name:
- Rhodamine B
- IUPAC Name:
- Rhodamine B
- Details on test material:
- - Name of test material: D&C Red 19
- Molecular formula: C28H31N2O3Cl
- Molecular weight: 479.017 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities: No data
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- other: Charles River CD-1, COBS (ICR derived)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Greeding Laboratories Wilmington, Massachusetts
- Age at study initiation: Weanlings (4-5 weeks)
- Weight at study initiation:
Mean Range
Male; 25 (16-31)
Female:22 (10-29)
- Housing: Individually in elevated stainless steel wire mesh cages.
Food-Standard laboratory diet (Puri na
Laboratory ) ad libitum. Fresh food presented twice weekly.
Water-Ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet
- Details on oral exposure:
- Appropriate amounts of the test chemical were mixed fresh weekly with standard 1aboratory diet. Diet analysis: Four ounce samples of the control and each dose level were collected weeks 1. 4. 8 and 13. and analysis was conducted by the Environmental and Analytical Chemistry Division of Bio/dynamics. Inc. Storage temperature: Room temperature
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Approximately one ounce of pure (compound was collected weeks 1, 4, 8 and 13; analysis conducted by the Environmental and Analytical Chemistry Division of Bio/dynamics, Inc.
- Duration of treatment / exposure:
- 90-91 days
- Frequency of treatment:
- (Daily) Continuously in the diet
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.001. 0.01, 0.1, 1.0 and 5.0%=1.66, 16.66, 166.66, 1666.66, 8333.33mg/kg bw.
Basis:
- No. of animals per sex per dose:
- 120 mice (60 males; 60 females).
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Weekly
BODY WEIGHT: Yes
Twice pretest, weekly during treatment, and terminally (after fasting) including organ weights of brain kidneys liver, spleen - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes Twice daily
HISTOPATHOLOGY: Yes - Other examinations:
- No data
- Statistics:
- Statistically significant differences from control are indicated in mean tables and appendices.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All males and females receiving 5.0: pure color died spontaneously during the first or second week of test substance administration. In addition, two males receiving 1.0: pure color died spontaneously during the course of the study. Five animals one from each of groups I through V, died accidentally on day 76 or 77 due to starvation.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Mean body weights for males and females receiving 1.0% pure color were generally lower than those of the control animals from week 1 through termination all differences were statistically significant and greater than 10%.
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Elevations, as compared to control, were noted in the abso1ute and relative (to body weight) mean liver weights for both sexes receiving 0.1 and 1.0% pure color all weights were significantly (p≤0.01) different. As compared to control, absolute mean spleen and kidney weights were, reduced and relative mean brain weights were elevated for both sexes receiving 1.0% pure color, .however these differences were considered a reflection of the lower mean
body weights for this group. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The mucosa of the gastrointestinal tract and the bila were tinted red in many animals at dose levels of 0.1 and 1.0%. None of the other changes observed in animals at the terminal sacrifice, nor in animals dying spontaneously or accidentally were considered related to the administration of D&C Red '19 at any dose level.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not specified
- Description (incidence and severity):
- Animals at the 0.1% level had a mild diffuse periportal hepatocellular hypertrophy with an increase in nuclear and cytoplasmic mass and narrowing of sinusoidal spaces considered to be test substance-related. Other changes were considered to be spontaneous in origin and not related to D&C Red #19 administration.
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 166.6 mg/kg diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Hepato-toxicity and variation in body weights
- Remarks on result:
- other: No toxic effects were observed .
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The No observed adverse effect level (NOAEL) was considered to be 166.66 mg/kg for test chemical
- Executive summary:
The study was conducted to determine the Maximum tolerated dose of test chemical in Charles river CD-1 mice .When administered Orally via the diet at dose levels of 0.001, 0.01, 0.1, 1.0 and 5.0% (1.66, 16.66, 166.66, 1666.66, 8333.33mg/kg bw/day)pure color for a period of 90-91 days. Animals were observed for mortality,clinical sign, food consumoption,organ weight,gross and histipathology.All animals receiving 5.0% color died by the second week of test substance administration, and two males receiving 1.0% died during the course of the study. With the exception of five animals which died accidentally, all other animals survived the duration of the study. Based on the results obtained with respect to hepatotoxicity and body weight changes along with the histopathological data, the No observed adverse effect level (NOAEL) was considered to be 166.66 mg/kg for test chemical as no significant effects were observed at this dose .
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