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EC number: 204-254-5 | CAS number: 118-47-8
- 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: sub chronic
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Reproductive Toxicology of Tartrazine (FD and C Yellow No. 5) in Swiss Albino Mice
- Author:
- N. Mehedi, S. Ainad-Tabet, N. Mokrane, S. Addou, C. Zaoui, O. Kheroua and D. Saidi
- Year:
- 2 009
- Bibliographic source:
- American Journal of Pharmacology and Toxicology 4 (4): 130-135
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- To evaluate the testicular toxicity of Tartrazine in male swiss albino mice and when they were mated with untreated female mice.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Tartrazine(FDand C yellow No.5)
- IUPAC Name:
- Tartrazine(FDand C yellow No.5)
- 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
- 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 (if other than submission substance):C16H12N4O9S2.3Na
- Molecular weight (if other than submission substance):534.36 g/mole
- Substance type:Organic
- Physical state:Liquid , dye
- Analytical purity:86.7%
- Impurities (identity and concentrations):No data available.
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: (P) x wks;- 4 weeks old (F1) x wks- No data available.
- Weight at study initiation: (P) Males: x-x g; - 20±2.01 g - Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): Standard food pellets diet was
given ad libitum
- Water (e.g. ad libitum): water was given ad libitum
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
They were kept under conditions of ambient room temperature and relative humidity.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency):
- Mixing appropriate amounts with (Type of food):
- Storage temperature of food:
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle: The average (±SE) tartrazine intake calculated from liquid consumption, in mg kg-1 day-1, was (173.9±0.25), (1767.8±0.32), (5541.4±0.47) for 0.1, 1 and 2.5% Tartrazine groups, respectively.
- Amount of vehicle (if gavage):
- Lot/batch no. (if required):
- Purity: - Details on mating procedure:
- - M/F ratio per cage:1:1 male and female
- Length of cohabitation:1 week
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy: Groups of Tartrazine treated mice, six males per dose group, were mated 1:1 with untreated females for 1 week. Females were then separated and allowed to gestate to term. For females that failed to deliver a litter, this was considered as a sign of male infertility whereas litter delivery indicated male fertility.
- 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:
- 13 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- 0, 0.1%, 1% and 2.5% Groups of Tartrazine treated mice, six males per dose group, were mated 1:1 with untreated females for 1 week. Females were then separated and allowed to gestate to term. For females that failed to deliver a litter, this was considered as a sign of male infertility whereas litter delivery indicated male fertility. Litter size and weight after 7, 14 and 28 days of growth were examined.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.1%, 1% and 2.5% (173.9±0.25,1767.8±0.32and 5541.4±0.47 mg/kg/day )
Basis:
- No. of animals per sex per dose:
- Total: 24
0 mg/kg/day- 6 male mice
173.9 mg/kg/day- 6 male mice
1767.8 mg/kg/day-6 male mice
5541.4 mg/kg/day-6 male mice - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available.
- Positive control:
- No data available.
Examinations
- Parental animals: Observations and examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
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): Yes
- Time schedule for examinations: Daily - Oestrous cyclicity (parental animals):
- No data available.
- Sperm parameters (parental animals):
Parameters examined in [all/P/F1/F2] male parental generations: For P generation
[testis weight, epididymis weight, daily sperm production, sperm count in testes, sperm count in epididymides, enumeration of cauda epididymal sperm reserve, sperm motility, sperm morphology, other:]-- Sperm motility, morphology and sperm production was observed.- Litter observations:
STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: [yes/no]- No
- If yes, maximum of [...] pups/litter ([...]/sex/litter as nearly as possible); excess pups were killed and discarded.- No data available
PARAMETERS EXAMINED
The following parameters were examined in [F1 / F2 / F3] offspring:F1,Litter size and weight after 7, 14 and 28 days of growth were examined.
[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, other:]
GROSS EXAMINATION OF DEAD PUPS:
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.]-No data available.- Postmortem examinations (parental animals):
- After mating, male mice were killed by cervical dislocation. Testes, epididymides were weighed immediately. The left epididymis was excised. The tail region tissue was minced with scalpels for approximately 1min and placed in a 37°Cincubator for 15 min, prior to determining sperm motility.
•Histologic examination: Histologic examination of testis was performed. The left testis was fixed in formalin-buffer. Six microns thick paraffin sections were stained with hematoxylin and eosin and examined by light microscopy. - Postmortem examinations (offspring):
- No data available.
- Statistics:
- The data is expressed as mean ± SE. Statistical test one way ANOVA was applied to find significant difference between values of various parameters recorded for control and treated animals. p<0.05 was considered statistically significant.
- Reproductive indices:
- Mating index was observed.
- Offspring viability indices:
- Yes
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
BODY WEIGHT AND FOOD CONSUMPTION (PARENTAL ANIMALS)-Body weight gain was significantly increased in 1767.8 mg/kg/day Tartrazine (p<0.05). This increased bodyweight gain is not evidence related dose.
FOOD and liquid CONSUMPTION (PARENTAL ANIMALS)- Significant decrease in the food consumption was observed at all dose level 173.9, 1767.8 and 5541.4 mg/kg day treated group compare to control.
Significant increase in the water consumption was observed at all dose level 173.9, 1767.8 and 5541.4 mg/kg day in treated group compare to control.
(Data not shown).
TEST SUBSTANCE INTAKE (PARENTAL ANIMALS)- No data available
REPRODUCTIVE FUNCTION: ESTROUS CYCLE (PARENTAL ANIMALS)No data available
REPRODUCTIVE FUNCTION: SPERM MEASURES (PARENTAL ANIMALS)- Total number of spermatids count was reduced significantly in the mice administered 5541.4 mg/kg/day tartrazine (p<0.01).
Sperm concentration in epididymides was reduced in all treated groups 173.9, 1767.8 and 5541.4 mg/kg day but sperm epididymis reserves were reduced significantlyonly in mice treated with 5541.4 mg/kg/day tartrazine (p<0.01).
The percentage motility was reduced in 1767.8 and 5541.4 mg/kg/day treated groups (p<0.01).
The percentage morphologically normal spermatozoa were significantly affected in 5541.4 mg/kg/day dose level of tartrazine (p<0.01).
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)- Male mating index was decreased in the 5541.4 mg/kg/day treated groups compared to the control values.
ORGAN WEIGHTS (PARENTAL ANIMALS)- A decrease of relative testis and seminal vesicles weight were observed in all treated groups 173.9, 1767.8 and 5541.4 mg/kg day compared to control but not statistically significant. However, their absolute weight did not change.
GROSS PATHOLOGY (PARENTAL ANIMALS)-No data available.
HISTOPATHOLOGY (PARENTAL ANIMALS)- Histological examination revealed that semniferous tubules were not identical with conjunctive tissue dystrophy in animals testes treated with 173.9 mg/kg/day tartrazine.
Intercellular connections were reduced and imperfect and dilation in some semniferous tubules of testis mice treated 1767.8 mg/kg/day tartrazine.
Significant damage was observed in testis mice treated with 5541.4 mg/kg/day tartrazine; extensive disruption in semniferous tubules, widening of the interstitial spaces and loss leydig cells.
Spermatogenic cells are affected and then depleted with absence of spermatozoa in the Lumen .
OTHER FINDINGS (PARENTAL ANIMALS)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 173.9 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant change were observed in the body weight ,reproductve fuction , Reproductive performance ,organ weight and histopathology ,litter size and weight.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, treatment-related
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Details on results (F1)
CLINICAL SIGNS (OFFSPRING)- There was significant decrease in the litter sizes in 1767.8 and 5541.4 mg/kg/day treated rats as comparison to litters sired from control males.
BODY WEIGHT (OFFSPRING)-There was significant decrease in the litter weight at treated dose group 173.9, 1767.8 and 5541.4 mg/kg/day comparison to litters sired from control males during lactation periiod.
Effect levels (F1)
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
This study attributed that the differences of offspring weight between the control and low-dosed groups were caused not by tartrazine treatment but by the body size at birth.
Applicant's summary and conclusion
- Conclusions:
- NOAEL was found to be 173.9±0.25 mg/kg/day (0.1%) for Tartrazine in male swiss albino mice for 13 weeks by oral drinking water administration .
- Executive summary:
A sub chronic study was conducted for Tartrazine in male swiss albino mice for 13 weeks.They were administrated Tartrazine at the concentration of 0, 0.1%, 1% and 2.5% (173.9 ±0.25, 1767.8±0.32and 5541.4±0.47 mg/kg/day ) by oral drinking water. Groups of Tartrazine treated mice, six males per dose group, were mated 1:1 with untreated females for 1 week. Females were then separated and allowed to gestate to term. For females that failed to deliver a litter, this was considered as a sign of male infertility whereas litter delivery indicated male fertility. Food and water consumption, body weight, reproductve fuction, Reproductive performance, organ weight and histopathology were observed. Decrase in food consumption and increase in water consumption were observed in 173.9, 1767.8 and 5541.4 mg/kg/day treated male rats as compared to control. Average (±SE) tartrazine intake calculated from liquid consumption, in mg kg-1day-1, was (173.9±0.25), (1767.8±0.32), (5541.4±0.47) for 0.1, 1 and 2.5% tartrazine groups, respectively. Significantly increased body weight gain was observed in 1767.8 mg/kg/day and decrease in relative testis and seminal vesicles weight in 173.9, 1767.8 and 5541.4 mg/kg/day treated male rats, but the effect were not statistically significant and no effect on absolute organ weight were observed in treated male rats as compared to control. Decreased in male mating index and body weight and litter sizes were observed in 5541.4 mg/kg/day treated male rats as compared to control. Similarly, significant decreased in Total number of spermatids count, Sperm concentration in epididymis reserves and percentage motility in 5541.4 mg/kg/day, percentage motility and Sperm concentration in epididymides in 1767.8 mg/kg/day and Sperm concentration in epididymides in 173.9 mg/kg/day treated male rats as compared to control. Sperm head (amorphous, macro-or microcephaly) and the sperm flagellum (entangled, twisted, coiled, with ANSA) morphological abnormalities and significantly affected percentage morphologically normal spermatozoa were observed in 5541.4 mg/kg/day treated male rats as compared to control. In addition, extensive disruption in semniferous tubules, widening of the interstitial spaces and loss leydig cells, Spermatogenic cells are affected and then depleted with absence of spermatozoa in the lumen at 5541.4 mg/kg/day, decreased intercellular connections and imperfect and dilation in some semniferous tubules of testis at 1767.8 mg/kg/day and emniferous tubules were not identical with conjunctive tissue dystrophy in testes at 173.9 mg/kg/day treated male rats as compared to control. Therefore NOAEL was considered to be173.9 mg/kg/day (0.1%) when swiss albino male mice treated with tartrazine orally by drinking water for 13 weeks.
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