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EC number: 233-418-9 | CAS number: 10149-98-1
- 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:
- 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 peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Study of the teratogenic potential of FD & C yellow no. 5 when given by gavage to rats
- Author:
- T. F. X. COLLJNS, T. N. BLACK, L. H. BROWN and P. BULHACK
- Year:
- 1 990
- Bibliographic source:
- Food Chem Toxic, Vol. 28, No. 12, pp. 821-827
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 421 (Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- To evalute the toxicity of Tartrazine in female Osborne-Mendel rats by gavage.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- EC Number:
- 217-699-5
- EC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Cas Number:
- 1934-21-0
- Molecular formula:
- C16H12N4O9S2.3Na
- IUPAC Name:
- Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report):Tartrazine
- Molecular formula :C16H12N4O9S2.3Na
- Molecular weight :534.36 g/mole
- Substance type:Organic
- Physical state:Liquid , dye
- Analytical purity:92.7%
- Impurities (identity and concentrations):No data available.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Tartrazine
- Molecular formula :C16H12N4O9S2.3Na
- Molecular weight :534.36 g/mole
- Substance type:Organic
- Physical state:Liquid , dye
- Analytical purity:92.7%
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: FDA rat breeding colony
- Age at study initiation: (P) female x wks; - 13-21 wk old, Male – No data available (F1) x wks
- Weight at study initiation: (P) Males: x-x g; - No data available. Females: x-x g;-210 -270 g (F1) Males: x-x g; No data available ,Females: x-x g- No data available
- Fasting period before study: No data available
- Housing: Housed in stainless-steel hanging cages.
- Diet (e.g. ad libitum): Purina Laboratory Chow, (Ralston Purina Company. St Louis, MO, USA) was available ad lib.
- Water (e.g. ad libitum): Distilled water was available ad lib.
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C):2 0.5-25C
- Humidity (%):30-50%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:not specified
DIET PREPARATION
- Rate of preparation of diet (frequency):not specified
- Mixing appropriate amounts with (Type of food):not specified
- Storage temperature of food:not specified
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: 0, 60, 100, 200, 400, 600 and 1000 mg/kg
- Amount of vehicle (if gavage): 1 ml/100g body weight
- Lot/batch no. (if required): not specified
- Purity not specified - Details on mating procedure:
- - M/F ratio per cage:1:2
- Length of cohabitation: No data available
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy- The presence of sperm in the vaginal
smear was considered to be evidence of copulation and the sperm positive females were considered to be at day 0 of gestation.
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.-No data available
- Further matings after two unsuccessful attempts: [no / yes (explain)]- No data available
- After successful mating each pregnant female was caged (how):-No data available
- Any other deviations from standard protocol:No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 19 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- FD & C Yellow No. 5 (tartrazine) was given to Osborne-Mendel rats by gavage at dose levels of 0, 60,100, 200, 400, 600 and 1000mg/kg body weight/day on days 0-19 of gestation. Maternal or developmental toxicity was observed till the rats were killed on day 20. Fetal skeletal and visceral development was observed among fetuses from all groups.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 60 mg/kg bw/day
- Dose / conc.:
- 100 mg/kg bw/day
- Dose / conc.:
- 200 mg/kg bw/day
- Dose / conc.:
- 400 mg/kg bw/day
- Dose / conc.:
- 600 mg/kg bw/day
- Dose / conc.:
- 1 000 mg/kg bw/day
- No. of animals per sex per dose:
- Total no of animals- 259 female rats
0 mg/kg /day -38 female rats
60 mg/kg /day -37 female rats
100 mg/kg /day -37female rats
200 mg/kg /day -35 female rats
400 mg/kg /day -38 female rats
600 mg/kg /day -38 female rats
1000 mg/kg /day -36 female rats - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 40-41 pregnant female randomly selected for dosing.
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS:Yes
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule:Daily
BODY WEIGHT: Yes
- Time schedule for examinations:Daily
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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
OTHER: - Oestrous cyclicity (parental animals):
- Any irregularity in estrous cyclicity were observed
- Sperm parameters (parental animals):
- No data available.
- Litter observations:
- The foetuses were grouped by litter for identification. Each live foetus was promptly weighed, sexed and examined for gross external malformations, and the crown-rump length was measured. Any foetus that weighed less than 70% of the average weight of the concurrent male or female controls was considered to be a runt. External visceral and sternebral variations were also observed.
- Postmortem examinations (parental animals):
- On day 20 of gestation, the females were examined for gross abnormalities for the last time before being killed by CO2 asphyxiation. Caesarean sections were performed, corpora lutea were counted and the uteri were opened and examined in situ. The uterine positions of all implantation sites were noted and their condition (early or late resorptions, alive or dead foetuses) was determined.
- Postmortem examinations (offspring):
- Approximately half of the foetuses were examined for skeletal variations after being fixed in alcohol, cleared and stained with Alizarin Red S by a modification of Dawson's method. The remaining foetuses were fixed in Bouin's solution and sectioned according to the method of Wilson in order to detect internal visceral variations. Specific sternebral variation were observed in all fetuses like Incomplete ,Bipartite, Missing and Malaligned.Specific soft tissue variation like Hydroureter,Enlarged renal pclvis,Ectopic kidney ,Haemorrhages , Hydrocephalus ,Ectopic/incomplete descended testes ,Ectopic ovary ,Microphthalmia ,Anophthalmia ,Oedema and Defective heart valve were observed . Skeletal variation like 15 rib,l4th rib l3th rib ,l2th rib, Ribs, fused Rjbs, wavy ribs,Centra. red. on. Centra, misshapen ,Centra, bipartite ,Centra, missing Centra, fused wI dorsal arches ,Vertebrae. missing Caudal ossiBcation ,Dorsal arches, red Dorsal arches, fused Interparietal, red. oss. , Pariewl, red ,Frontal, red oss. ,Nasal red. oss. Supraoccipital, red. Oss,Supraoccipitaf. bipartite Hyoid. Red oss.Squuamosa, red. Zygomatic, red. ms. ,Pubis, red oss. Metacarpals, red. w Scapula. red oss. ,Scapula, curved ,
Clavicle, misshapen Maxillary, red. oss. ere observed . - Statistics:
- Statistical method like ANOVA, Fishers exact test, t-test etc were used.
- Reproductive indices:
- Fertility index and delivery index were observed.
- Offspring viability indices:
- Viability index was observed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No significant change were observed in behaviour and clinical sign.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality was observed .Except one female in the group given 60 mg/kg body weight/day died at day 13 of gestation of gavage difficulties unrelated to dosage.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- No significant change were observed in body weight at all treated group 60, 100, 200, 400 and 600 mg/kg/day compare to control.
Except at dose group 1000 mg/kg/day, where body weight increased compare to control. Initial body weight at day 0 and maternal body-weight gain during gestation did not vary significantly between treated and control groups. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- No significant change were observed in food consumption at all treated group 60, 100, 200, 400 and 600 mg/kg/day compare to control.
Except at dose group 1000 mg/kg/day, where food consumption increased compare to control. - 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:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- 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:
- no effects observed
- Description (incidence and severity):
- No significant change were observed in% pregnent rats and % implantation efficiency in all treated group at 60, 100, 200, 400, 600 and 1000 mg/kg /day as compare to control.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- gross pathology
- reproductive performance
- Remarks on result:
- other: No effect on reproductive performance
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:
- no mortality observed
- Description (incidence and severity):
- No significant change were observed in the viability for male and female fetuses in all treated group compare to control.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant changes were observed in the body weight of male and female fetuses in all treated group compare 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:
- 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:
- no effects observed
- Description (incidence and severity):
- No significant change were observed in Specific sternebral variation all treated group60, 100, 200, 400, 600 and 1000 mg/kg /day compare to control.
No significant changes were observed in Specific Skeletal variation in all treated group60, 100, 200, 400, 600 and 1000 mg/kg /day compare to control. - Histopathological findings:
- no effects observed
- Description (incidence and severity):
- No significant change were observed in Specific soft tissue variation like Hydroureter, Enlarged renal pclvis, Ectopic kidney, Haemorrhages , Hydrocephalus ,Ectopic/incomplete descended testes, Ectopic ovary, Microphthalmia, Anophthalmia, Oedema and Defective heart valve all treated group60, 100, 200, 400, 600 and 1000 mg/kg /day compare to control.
- Other effects:
- no effects observed
- Description (incidence and severity):
- No significant change were observed in the crown rump length of male and female foetuses in all treated group compare to control.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- other: No effect on crown rump length
- Remarks on result:
- other: No effect on viability, body weight, gross pathology and histopathology
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
Any other information on results incl. tables
To preclude the possibility of bias, all evaluations of the dams and foetuses during caesarean sections and during skeletal or visceral analysis were done without the evaluators knowing the dose-level group to which the animals belonged. Maternal and reproductive outcome at autopsy and foetal data at rats given F D &C yellow no.5 by gavage.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw/day for F0 and F1 generation when Osborne-Mendel female rats were treated with Tartrazine orally by gavage for 17 days.
- Executive summary:
In a Teratogeninc potential study, Osborne-Mendel female rats were treated with Tartrazine in the concentration of 0, 60, 100, 200, 400, 600 and 1000 mg/kg /day orally by gavage in water. One female in 60 mg/kg body weight/day died on day 13 of gestation of gavage difficulties unrelated to dosage. No clinical sign of toxicity were observed in treated female rats as compared to control. Significant increase in food consumption at 1000 mg/kg body weight/day and no effect on body weight were observed in treated female rats as compared to control. No effect on % of pregnant female, no of corpora, implantation, no of viable foetuses, 5 resorptions, early death or late deaths per litter and sex ratio of treated rats as compared to control. Similarly, no effect on foetuses viability and body weight were observed in treated rats. In addition, three hydrocephalic pups in a single litter and isolated increase in the number of litters containing foetuses with at least two types of stemebral variations in foetuses at 200 mg/kg body weight/day, significant increase in haemorrhages at 600 mg/kg body weight/day and four foetuses from three litters at 1000 mg/kg body weight/day were observed but, The incidences of foetuses with visceral variations and of litters containing those foetuses were similar in all groups. Therefore, NOAEL was considered to be 1000 mg/kg bw/day for F0 and F1 generation when Osborne-Mendel female rats were treated with Tartrazine orally by gavage for 19 days.
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