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EC number: 955-780-3 | CAS number: -
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
The No Observed Adverse Effect level (NOAEL) for the test chemical for reproduction toxicity in test animals were considered to be 750 mg/Kg bw/day.
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Chronic toxicity study of food colours TARTRAZINE, AMARANTH AND SUNSET YELLOW were observed in rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Not available
- Age at study initiation: 6 and 7 weeks
- Weight at study initiation: 129 g-males and 105 g-females(appx)
- Fasting period before study: Not available
- Housing: Individual cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not available
- Humidity (%):Not available
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): Not available - Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Alphacel
- Remarks:
- a non-nutritive cellulose
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:Alphacel (a non-nutritive ce!lulose) was added so that the level of dye plus alphacel was 1.5 per cent. The control diet contained 1.5 per cent alphacel.
DIET PREPARATION
- Rate of preparation of diet (frequency):Not available
- Mixing appropriate amounts with (Type of food):Alphacel (a non-nutritive ce!lulose) diet
- Storage temperature of food: Not available
VEHICLE
- Justification for use and choice of vehicle (if other than water): Alphacel(a non nutritive cellulose)-No justification available.
- Concentration in vehicle: 0, appx 15,150 and 750 mg/kg
- Amount of vehicle (if gavage): Not available
- Lot/batch no. (if required): Not available
- Purity: Not available - Details on mating procedure:
- Mating was not performed.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 64 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 15 mg/kg bw/day (nominal)
- Dose / conc.:
- 150 mg/kg bw/day (nominal)
- Dose / conc.:
- 750 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Total: 120
Control - 15 males and 15 females
15 ma/kg bw - 15 males and 15 females
150 mg/kg bw - 15 males and 15 females
750 mg/kg bw- 15 males and 15 females - Control animals:
- other: control diet contained 1.5 per cent alphacel.
- Details on study design:
- After 26 weeks on test, five rats of each group receiving 1.5 per cent colourwere killed for histological examination. Haemoglobin estimations were done using a slight modification of the
pyridine-haemochromogen method of Rimington. At the end of the experiment, electrocardiograms and electroencephalograms were recorded from six rats of each sex on the control diet and three rats of each sex on the 1.5 per cent level of each colour, - Positive control:
- not specified
- Parental animals: Observations and examinations:
- Mortality, Body weight, food consumption and food efficiency were examined.
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- No data
- Postmortem examinations (parental animals):
- Necroscopies were performed on rats that died during the test. After 26 weeks on test, five rats of each group receiving 1.5 per cent colour were killed for histological examination. Haemoglobin estimations were done(Hb,RBC,WBC,Differential cell counts)
Gross examination-After 64 weeks all surviving rats were anaesthesized with ether on all organs and tissues gross examined .
Organ weights recorded.
Histopathological examination-Tissues with gross pathology change was studied for histopathology.
Tissues examined -Lung, liver, heart, spleen, thyroid, pancreas, stomach, small intestine, kidney, urinary bladder, adrenal, testis, prostate, coagulating gland, ovary, uterus, and thymus. - Postmortem examinations (offspring):
- No data
- Statistics:
- Statistics –significant differences between mean values were determined by Student’s“t”test (forgrowth, food consumption and food efficiency).
- Reproductive indices:
- No data
- Offspring viability indices:
- No data
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No effect on survival of treated male and female rats were observed at 15, 150 and 750 mg/kg bw as compared to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease in mean body weight in females at 4, 32 and 16 weeks.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Decreased in food consumption of females were observed with no correlation with the concentration given in diet.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- No significant difference in male or female food efficiency was observed as compared to control.
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The only significant difference observed was lowered white cell count for females at 750 mg/kg bw as compared to controls. No adverse effect on blood cells was 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, non-treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Middle ear and respiratory infections were observed, considered to be in older rats of the colony. Chronic otitis media was observed in nearly 50 per cent of the animals. The disease was evenly distributed in the various groups.
Pathological changes in the adrenal cortex were observed in 22 animals. This particular pathology was acute in nature and was not considered to be an effect of the food colours since it was observed in two of the control animals and since there was no correlation between the incidence and the concentration of colour fed. - Histopathological findings: neoplastic:
- no effects observed
- Description (incidence and severity):
- 18 per cent tumour incidence was observed in treated rats. The differences in tumour incidence are not significant according to chi-square tests.
- Other effects:
- no effects observed
- Description (incidence and severity):
- The tracings of ECG were essentially normal. No significant deviation of electrical axis observed in treated rats.
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 750 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- mortality
- body weight and weight gain
- food consumption and compound intake
- food efficiency
- haematology
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- histopathology: neoplastic
- other: No significant effect on reproductive organ weight and histopathology of sexual organs testis,ovary and uterus.
- Remarks on result:
- other: No toxic effect were observed.
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- 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
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- NOAEL was considered to be 750 mg/kg bw when male and female rats were treated with test chemical orally in feed Alphacel (a non-nutritive cellulose) for 64 weeks.
- Executive summary:
In a chronic toxicity study, male and female rats were treated with test chemical in the concentration of 0, 15, 150 and 750 mg/kg bw orally in feed Alphacel (a non-nutritive cellulose) for 64 weeks. No effect on survival of treated male and female rats were observed at 15, 150 and 750 mg/kg bw as compared to control. Decrease in mean body weight in females at 4, 32 and 16 weeks. Decreased in food consumption of females were observed with no correlation with the concentration given in diet. No significant difference in male or female food efficiency was observed as compared to control. The only significant difference observed was lowered white cell count for females at 750 mg/kg bw as compared to controls. No adverse effect on blood cells was observed. Similarly, Decrease in liver weight at 150 mg/kg bw and spleen weight at 750 mg/kg bw in female rat. These changes were not correlated with the level of food colour in the diet and are difficult to interpret. No effects on reproductive organs were observed in treated male and female rats as compared to control. Respiratory tract infections accounted for 28 deaths. Two animals died of starvation, one of meningitis, one of a ruptured right auricle and three as the result of neoplasms. In addition, Middle ear and respiratory infections were observed, considered to be in older rats of the colony. Chronic otitis media was observed in nearly 50 per cent of the animals. The disease was evenly distributed in the various groups. Pathological changes in the adrenal cortex were observed in 22 animals. This particular pathology was acute in nature and was not considered to be an effect of the food colours since it was observed in two of the control animals and since there was no correlation between the incidence and the concentration of colour fed. 18 per cent tumour incidence was observed in treated rats. The differences in tumour incidence are not significant according to chi-square tests. The tracings of ECG were essentially normal. No significant deviation of electrical axis observed in treated rats. Therefore, NOAEL was considered to be 750 mg/kg bw when male and female rats were treated with test chemical orally in feed Alphacel (a non-nutritive cellulose) for 64 weeks.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 750 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Weight of evidence prepared from two well qualified publication.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity study:
1. In a chronic toxicity study, male and female rats were treated with test chemical in the concentration of 0, 15, 150 and 750 mg/kg bw orally in feed Alphacel (a non-nutritive cellulose) for 64 weeks. No effect on survival of treated male and female rats were observed at 15, 150 and 750 mg/kg bw as compared to control. Decrease in mean body weight in females at 4, 32 and 16 weeks. Decreased in food consumption of females were observed with no correlation with the concentration given in diet. No significant difference in male or female food efficiency was observed as compared to control. The only significant difference observed was lowered white cell count for females at 750 mg/kg bw as compared to controls. No adverse effect on blood cells was observed. Similarly, Decrease in liver weight at 150 mg/kg bw and spleen weight at 750 mg/kg bw in female rat. These changes were not correlated with the level of food colour in the diet and are difficult to interpret. No effects on reproductive organs were observed in treated male and female rats as compared to control. Respiratory tract infections accounted for 28 deaths. Two animals died of starvation, one of meningitis, one of a ruptured right auricle and three as the result of neoplasms. In addition, Middle ear and respiratory infections were observed, considered to be in older rats of the colony. Chronic otitis media was observed in nearly 50 per cent of the animals. The disease was evenly distributed in the various groups. Pathological changes in the adrenal cortex were observed in 22 animals. This particular pathology was acute in nature and was not considered to be an effect of the food colours since it was observed in two of the control animals and since there was no correlation between the incidence and the concentration of colour fed. 18 per cent tumour incidence was observed in treated rats. The differences in tumour incidence are not significant according to chi-square tests. The tracings of ECG were essentially normal. No significant deviation of electrical axis observed in treated rats. Therefore, NOAEL was considered to be 750 mg/kg bw when male and female rats were treated with test chemical orally in feed Alphacel (a non-nutritive cellulose) for 64 weeks.
2. Reproductive study was conducted for test chemical in male and female CFW mice for 80 weeks by oral feed. When Groups of 30 male and 30 female CFW mice were given diets containing 0.1, 0.25, 0.5 and 1.0% test chemical for 80 wk, with groups of 60 mice of each sex as controls. There were no dose-related effects on body-weight gain, haematology and organ weights. The incidence of histopathological findings was not altered by the feeding of test chemical. Therefore it is considered that test chemical to the diet of male and female CFW mice at levels up to 1% (equivalent to approximately 1300 mg/kg/day) for 80 wk does not induce any reprotoxic effect.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria the test chemical is not likely to exhibit reproductive toxicant substance. Hence the substance cannot be classified as reproductive toxicant.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.