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EC number: 224-924-0 | CAS number: 4553-89-3
- 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:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Long-Term Toxicity Studies on Chocolate Brown HT In Rats
- Author:
- Francis M.B. Carpanini, Kenneth R. Butterworth, Ian F. Gaunt, Ida S. Kiss, Paul Grasso And Sharat D. Gangolli
- Year:
- 1 978
- Bibliographic source:
- Toxicology, 11 (1978) 303-307
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Combined repeated dose & carcinogenicity study of Chocolate Brown HT in rats orally.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- EC Number:
- 224-924-0
- EC Name:
- Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- Cas Number:
- 4553-89-3
- Molecular formula:
- C27H20N4O9S2.2Na
- IUPAC Name:
- disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium 4,4’-(2,4-dihydroxy-5- hydroxymethyl-1,3-phenylene bis-azo) di- (naphthalene-1-sulfonate)
- Molecular formula: C27H20N4O9S2.2Na
- Molecular weight: 654.58 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Specified pathogen-free breeding Colony
- Age at study initiation: No data available
- Weight at study initiation:
(P) Males: 54-80 g
(P) Females: 53-82 g
- Fasting period before study: No data available
- Housing: 4/cage
- Diet (e.g. ad libitum): ground Spratts Laboratory Diet No.1 ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20± 1°C
- Humidity (%): 50-60%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Ground Spratts Laboratory Diet No. 1
- Details on exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): Chocolate Brown HT was incorporated at 0, 500, 2000 or 10 000 ppm in diet.
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Ground Spratts Laboratory Diet No. 1
- Concentration in vehicle: 0, 25, 100 and 500 mg/Kg/day in the diet
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 25, 100 and 500 mg/Kg/day (0, 500,2000 and 10000 ppm)
Basis:
nominal in diet
- No. of animals per sex per dose:
- Total: 384
0 ppm: 48 male, 48 female
500 ppm: 48 male, 48 female
2000 ppm: 48 male, 48 female
10000 ppm: 48 male, 48 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Observations and examinations performed & frequency
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked: Cumulative mortality was observed
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: On first day of feeding and at 1, 4, 7 and 11 weeks of treatment and thereafter at approx. 3-monthly intervals up to week 102
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: No data
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: measured over the 48-h period commencing at the same time as the food intake
OTHER:
Haematology, clinical chemistry, urinalysis and Organ weight were examined. - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- Parameters examined in [P] male parental generations: testis weight
- Litter observations:
- Not applicable
- Postmortem examinations (parental animals):
- GROSS PATHOLOGY: Yes
Any macroscopic abnormalities were observed.
Samples of all major tissues and organs and of any other tissue appearing abnormal at autopsy were preserved in 10% buffered formalin until prepared for histological examination.
HISTOPATHOLOGY: Yes
Organ examined: Brain, heart, liver, spleen, kidneys, stomach, small intestine, caecum, adrenals, gonads, pituitary and thyroid were weighted. - Postmortem examinations (offspring):
- No data available
- Statistics:
- Statistical calculations are based on a level of significance of at least P = 0.05.
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- Cumulative mortality was similar in the treated and control animals throughout the 2-year period except for one statistically significant value at week 72 (7 deaths compared with none in the controls) in males given 500mg/Kg/day
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significant decrease was observed in 500 mg/kg/day treated rats as compared to control at 102 week in male and 78 week in female.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significant decrease was observed in 500 mg/kg/day treated rats as compared to control at 102 week in male and 78 week in female.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- 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
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- High incidence of adenosis and fibroadenosis in the female rats, but the incidences in the treated and control animals showed no statistical differences.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
The approximate total intakes of colouring consumed per rat up to week 66 were for the low, medium and high treatment levels respectively, 5.25, 21.5 and 109.8 g by the males and 4.15, 17.0 and 83.9 g by the female rats. The corresponding values up to week 102 were 8.11, 32.3 and 160.8 g/rat by the males and 6.38, 21.1 and 128.2 g/rat for the females.
ORGAN WEIGHTS (PARENTAL ANIMALS)
A slight reduction in testis weight at 25 mg/Kg day observed. This was not considered to be treatment related.
HISTOPATHOLOGY (PARENTAL ANIMALS)
When treated with 2000 and 10000 ppm, in male rat wide range of pathological changes in liver and kidney with lower incidence of fatty change in the livers were observed as compared to control.
High incidence of adenosis and fibroadenosis in the female rats were observed, but the effect was not statistically significant as compared to control.
OTHER
HAEMATOLOGY:
When treated with 10000 ppm, in male and female rat significant decrease were observed in hemoglobin at 55 week, WBC at 27 and 55 week in male rat and significant increase in RBC at 27 week in male and female rat as compared to control.
When treated with 2000 ppm, significant increase was observed in RBC of male and female rat and increase in WBC in female as compared to control.
Observed effect was not considered to be treatment related.
CLINICAL CHEMISTRY: No significant differences between treated and control animals observed.
URINALYSIS: No significant differences between treated and control animals observed
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- food consumption and compound intake
- water consumption and compound intake
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: no reprotoxic
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
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
Overall reproductive toxicity
- Reproductive effects observed:
- no
- 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 500 mg/kg/day (10000 ppm) for F0 generation when Wistar male and female rats treated with Chocolate Brown HT (Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate).
- Executive summary:
In a Combined repeated dose & carcinogenicity study, male and female Wistar rats were treated with Chocolate Brown HT (Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate) orally at the concentration of 0, 500, 2000 and 10000 ppm. No effect were observed on overall mortality rate, food consumption, water intake, hematology, clinical chemistry, urine analysis and organ weight of 10000 ppm treated male and female rats as compared to control in F0 generation. In addition, lower incidence of fatty change in the livers in male, adenosis and fibroadenosis in the female and tumours of mammary adenomas and fibroadenomas in the female rats, interstitial cell tumours of the testis and subcutaneous fibromas in both sexes were observed. The observed effects were not related to treatment in F0 generation.
Therefore, NOAEL was considered to be 500 mg/kg/day (10000 ppm) for F0 generation when Wistar male and female rats treated with Chocolate Brown HT orally for 2 years.
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