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EC number: 222-657-4 | CAS number: 3567-69-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Long-Term Toxicity Studies of Carmoisine in Mice
- Author:
- P. L. Mason, I. F. Gaunt, K. R. Butterworth, Joan Hardy, Ida S. Kiss and P. Grasso
- Year:
- 1 974
- Bibliographic source:
- Fd Cosmet. Toxicol. Vol. 12 pp. 601-607, 1974
Materials and methods
- Principles of method if other than guideline:
- Carmoisine was tested for its carcinogenic activity using mouse as the test animal
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate
- EC Number:
- 222-657-4
- EC Name:
- Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate
- Cas Number:
- 3567-69-9
- Molecular formula:
- C20H12N2Na2O7S2
- IUPAC Name:
- disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate
- Details on test material:
- - Name of test material (as cited in study report): Carmoisine
- Molecular formula (if other than submission substance): C20H14N2O7S2.2Na
- Molecular weight (if other than submission substance): 502.4338 g/mol
- Substance type: organic
- Physical state: No data available
Purity No data available
- Impurities (identity and concentrations): Dye content, min 85%; matter volatile at 135°C, max 10%; matter insoluble in water, max 0.1%; matter soluble in diisopropyl ether, max 2.0%;
subsidiary dyes, max 2"0~o; chlorides and sulphates (as sodium salts), max 5%; copper,
max 10 ppm; arsenic, max 1 ppm; lead, max 10 ppm; heavy metals (as sulphides) not producing more intense colour than the reference standard.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: ASH/CS1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: The mice were housed in cages of five
- Diet (e.g. ad libitum): Oxoid pasteurized breeding diet supplemented with 80 ppm vitamin K3 ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 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: Feed
- Details on exposure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data available
- Duration of treatment / exposure:
- Duration of exposure: 80 weeks
- Frequency of treatment:
- Daily
- Post exposure period:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.01, 0.05, 0.25 or 1.25 % (14.3, 71.4, 357.1 or 1785.7 mg/kg bw)
Basis:
- No. of animals per sex per dose:
- Total: 300
0 mg/kg bw: 60/sex/dose
14.3 mg/kg bw: 30/sex/dose
71.4 mg/kg bw: 30/sex/dose
357.1 mg/kg bw: 30/sex/dose
1785.7 mg/kg bw: 30/sex/dose - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- Observation and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes
- Time schedule: under continual surveillance
- Cage side observations checked in table [No.?] were included. any abnormalities in condition
or behaviour
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
DERMAL IRRITATION (if dermal study): No data - Time schedule for examinations: No data
BODY WEIGHT: Yes
- Time schedule for examinations: weighed every 2 wk up to wk 57 and at the end of the study
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- 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): No data
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: ten animals from the control group and those given the two highest dietary levels (0.25 and 1.25%) at wk 12, 24 and 52
- Parameters checked in table [No.?] were examined. The blood was examined for haemoglobin concentration and packed cell volume, and the numbers of erythrocytes and leucocytes were counted. In addition, differential leucocyte and reticulocyte counts were made on the blood samples from the mice fed the control diet and those fed the highest level of carmoisine. At the end of the study the blood samples from all surviving animals were examined for haemoglobin and differential leucocytes only.
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- Scarifies And Pathology:
GROSS PATHOLOGY:
Yes, An autopsy was conducted at which any macroscopic abnormalities were noted
HISTOPATHOLOGY:
Yes, the brain, heart, liver, spleen and kidneys were weighed. Samples of these tissues, together with salivary gland, thyroid, adrenal glands, lymph nodes, pancreas, pituitary, ovaries, uterus, urinary bladder, trachea, lungs, oesophagus, stomach, small intestine, colon, rectum, spinal cord and skeletal muscle and any other tissue that appeared to be abnormal, were preserved in 10% buffered formalin. Paraffin-wax sections of these tissues were stained with
haematoxylin and eosin. All tissues from the mice fed control diet and those fed 1.25%
carmoisine were examined microscopically, while at the lower dietary levels examination was confined to the heart, liver and kidney together with any tissue that appeared to be abnormal at autopsy. - Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- 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
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Clinical signs: There was external contamination of the fur by the coloured diet. The faeces in the mice given dietary levels of 357.1 or 1785.7 mg/Kg bw were normally coloured when voided, but rapidly (in 1-2 min) darkened to a purple colour on exposure to the air. There was some red colouring of the urine at most dose levels but samples taken with precautions against contamination showed no red colour, although at the 1785.7 mg/Kg bw level there was a slight brownish colour. The ingestion of carmoisine had no effect on either the condition or the behaviour of the animals.
Mortality:
Although deaths occurred in all treatment groups during the study, there was no association between the death rate or the total number of animals dying and the presence of carmoisine in the diet.
BODY WEIGHT AND WEIGHT GAIN carmoisine was not found to have any adverse effect on the rate of body-weight gain
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study) No data available
FOOD EFFICIENCY No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study) No data available
OPHTHALMOSCOPIC EXAMINATION No data available
HAEMATOLOGY In female mice given 1785.7 mg/kg bw, the haemoglobin concentration was significantly lower than the controls after treatment for 12 and 52 wk. In male mice, the same effect was seen at wk 52 with dietary levels of 357.1 or 1785.7 mg/kg bw. In both sexes given 1785.7 mg/kg bw carmoisine for 12 wk, this finding was associated with a lower
reticulocyte count and at wk 52 the packed cell volume was lower in the females. The only
significant difference in the leucocytes was a reduced total count in the females given the
highest dietary level of carmoisine for 24 wk.
CLINICAL CHEMISTRY No data available
URINALYSIS No data available
NEUROBEHAVIOUR No data available
ORGAN WEIGHTS There were no differences in absolute or relative organ weights, between the treated and control mice
GROSS PATHOLOGY At autopsy the contents of the small intestine, but not the caecum or colon, were coloured red in mice given 357.1 or 1785.7 mg/kg bw carmoisine. On exposure to air the contents of the caecum and colon became purple-coloured.
HISTOPATHOLOGY: NON-NEOPLASTIC No data available
HISTOPATHOLOGY: NEOPLASTIC The histopathological changes were those normally encountered in mice of this age and the incidence was similar in all treatment groups within each sex. Pulmonary adenomas were present in both male and female groups in similar numbers. A hepatocellular adenoma and a subcutaneous fibroma occurred in two male control mice and a single granulosa-cell tumour was found in a female control. There were three renal adenomas in male mice, one in each of the groups fed 0 (control), 14.3 and 357.1 mg/Kg bw carmoisine. Several malignant tumours occurred in both male and female mice. Two fibrosarcomas and a mammary adenocarcinoma were found in two male mice fed control diet and one female mouse fed 357.1 mg/Kg bw, respectively. Neoplasms of the reticulo-endothelial system included lymphomas in two male controls and a lymphosarcoma in a male mouse fed 357.1 mg/Kg bw carmoisine. Lymphoblastomas occurred in both male and female mice, with a similar incidence in all groups.
HISTORICAL CONTROL DATA (if applicable) No data available
OTHER FINDINGS No data available
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 785.7 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No carcinogenic potential noted of the test chemical
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
Any other information on results incl. tables
Table: Mortality observed in male and female mice
|
14.3 mg/kg bw |
71.4 mg/kg bw |
357.1 mg/kg bw |
1785.7 mg/kg bw |
Male |
6 |
3 |
3 |
6 |
Female |
5 |
3 |
3 |
7 |
Table: Mean body weight gain
|
14.3 mg/kg bw |
71.4 mg/kg bw |
357.1 mg/kg bw |
1785.7 mg/kg bw |
Male |
19 |
18 |
17 |
17 |
Female |
18 |
19 |
19 |
15 |
A mean gain of 18 g in controls of both sexes
Applicant's summary and conclusion
- Conclusions:
- Carmoisine showed no carcinogenic effect when given to mice at dietary levels of up to 1.25% (equivalent to an intake of approximately 1800-2000 mg/kg body weight/day). The No Observed Adverse Effect Level (NOAEL) for the test compound carmoisine is found to be 1.25% (1785.7 mg/Kg bw).
- Executive summary:
Carmoisine was tested for its carcinogenic activity using mouse as the test animal.
Carmoisine was fed to mice at dietary levels of 0 (control),0.01, 0.05, 0.25 or 1.25 % (14.3, 71.4, 357.1 or 1785.7 mg/kg bw)for 80 wk. There were no adverse effects on mortality, weight gain, organ weights or the incidence ofhistopathological findings, including tumours. There was a mild anaemia in the mice given 1.25%carmoisine. It is concluded that carmoisine has no carcinogenic potential in mice at dietary levelsup to 1.25% (equivalent to an intake of approximately 1800-2000 mg/kg body weight/day).
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