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EC number: 260-925-2 | CAS number: 57741-47-6
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Chronic
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is fom WHO
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Summary of toxicological data of certain food additives
- Author:
- WHO
- Year:
- 1 977
- Bibliographic source:
- WHO FOOD ADDITIVES SERIES NO. 12, INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION, 18-27 April 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Chronic toxicity study
- Principles of method if other than guideline:
- Chronic repeated dose oral toxicity study of RED 2G in mice.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 223-098-9
- EC Name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3734-67-6
- Molecular formula:
- C18H13N3Na2O8S2
- IUPAC Name:
- disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Red 2G
- IUPAC Name:
- Red 2G
- Details on test material:
- - Name of test material (as cited in study report): RED 2G
- Molecular formula (if other than submission substance): C16H12N2O4S.Na
- Molecular weight (if other than submission substance): 350.3289 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): RED 2G
- Molecular formula (if other than submission substance): C16H12N2O4S.Na
- Molecular weight (if other than submission substance): 350.3289 g/mole
- Substance type: Organic
Test animals
- Species:
- mouse
- Strain:
- other: Colworth C57B1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Diet
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test material was mixed in diet.
DIET PREPARATION- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food):
Diet- Storage temperature of food: No data availble
VEHICLE
- Justification for use and choice of vehicle (if other than water): Diet
- Concentration in vehicle: 0, 0.005, 0.025, 0.125 or 0.625%
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 80 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 7.5 mg/kg bw/day
- Dose / conc.:
- 37.5 mg/kg bw/day
- Dose / conc.:
- 187.5 mg/kg bw/day
- Dose / conc.:
- 937.5 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 400 mice
Control: 40 males, 40 females
7.5 mg/kg bw: 40 males, 40 females
37.5 mg/kg bw: 40 males, 40 females
187.5 mg/kg bw: 40 males, 40 females
937.5 mg/kg bw: 40 males, 40 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- Survival, clinical sign, body weight, food intake, hematology, clinical chemistry and urine analysis were examined.
- Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- not specified
- Postmortem examinations (parental animals):
- Organ weight and histopathology were examined.
- Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effect on growth of treated mice were observed as compared to control.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- More than three-quarters of mice survival in all the treated groups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effect on growth of treated mice were observed as compared to control.
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Heinz bodies and increased methemoglobin were observed in 187.5 and 937.5 mg/kg bw/day-treated mice.
- 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:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 187.5 and 937.5 mg/kg bw/day, splenic darkening and enlargement, increased splenic hemosiderin content and accelerated splenic erythropoiesis were observed in treated mice as compared to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 937.5 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No adverse effect on reproductive organ weight.
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 937.5 mg/kg bw for male mice when male and female Colworth C57B1 mice were treated with RED 2G.
- Executive summary:
In chronic repeated dose oral toxicity study, male and female Colworth C57B1 mice were treated with RED 2G in the concentration of 0, 7.5, 37.5, 187.5 or 937.5 mg/kg bw/day in feed. No effect on survival or growth of treated mice were observed. Heinz bodies and increased methemoglobin were observed in 187.5 and 937.5 mg/kg bw/day treated mice. No effect on brain, heart, liver, spleen, kidneys or testes weight were observed in treated mice as compared to control. Splenic darkening and enlargement, increased splenic hemosiderin content and accelerated splenic erythropoiesis were observed in treated mice as compared to control, but no effect were observed on testes of male mice. Therefore, NOAEL was considered to be 937.5 mg/kg bw for male mice when male and female Colworth C57B1 mice were treated with RED 2G orally in diet for 80 weeks.
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