Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 217-699-5 | CAS number: 1934-21-0
- 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:
- two-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- AY23 - CHRONIC TOXICITY/CARCINOGENICITY STUDIES OF FD & C YELLOW NO. 5 (TARTRAZINE) IN RATS
- Author:
- J. F. BORZELLECA and J. B. HALLAGAN
- Year:
- 1 988
- Bibliographic source:
- Fd Chem. Toxic. Vol. 26, No. 3, pp. 179-187, 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)
- Version / remarks:
- The reporduction toxicity was investigated during the OECD 453 study where treatment-related effects on fertility, gestation, parturition, lactation, pup survival through weaning or number of alive and still-born pups were checked.
- Deviations:
- not specified
- 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:
- solid: particulate/powder
- Details on test material:
- No data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Charles River CD rats obtained from Charles River Breeding Laboratories, Wilmington, MA, were 63-70 days old at the initiation of the F 0 phase of the study. They were housed individually in stainless-steel cages except during the mating, lactation and post-weaning periods of the in utero phase. Each rat was identified with a metal ear tag. If this was lost the animal was re-tagged and/or toe- clipped. The rats were housed in an environmentally controlled room (20-21°C, 40-60% relative humi- dity) on a 12-hr light/dark cycle. Food was avail- able ad lib. Control animals received Purina Rodent Chow (Ralston Purina Co. Inc., St Louis, MO) and the treated animals received the appropriate dietary admixture.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Fresh diets were prepared and presented weekly. The diets were blended in a twin-shell blender and assays were per- formed to determine the homogeneity and stability of the tested substance in the prepared diets prior to the start of the study. Dietary concentrations of the compound were determined weekly during the first 13 wk of the study, and then monthly thereafter. Analyses of the basic feed for heavy metals, chlorin- ated hydrocarbons and aflatoxin were conducted on all lots of feed used during the study. These analyses demonstrated that the basic feed contained accept- ably low levels of contaminants, that the diets were prepared properly, and that the dietary content of the test material was stable.
- Details on mating procedure:
- No data
- Analytical verification of doses or concentrations:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.1 other: %
- Remarks:
- In the "in utero" phase / original study: 360 rats
- Dose / conc.:
- 1 other: %
- Remarks:
- In the "in utero" phase / original study: 360 rats
- Dose / conc.:
- 2 other: %
- Remarks:
- In the "in utero" phase / original study: 360 rats
- Dose / conc.:
- 5 other: %
- Remarks:
- In the "in utero" / high dose study: 120 rats
- Dose / conc.:
- 5 other: %
- Remarks:
- In the chronic phase
- No. of animals per sex per dose:
- In the "in utero" phase / original study: 360 rats (60/sex/group) at levels of 0.1, 1.0 or 2.0% in diet
In the "in utero" / high dose study: 120 rats (60/sex/group) received the compound at a level of 5.0%
In the chronic phase: 70/sex/group received the compound at a level of 5.0% - Control animals:
- yes, plain diet
- Details on study design:
- Three control groups containing 360 rats (60/sex/group) received the basal diet only. Female rats were weighed on gestation days 0, 4, 14 and 21.
Examinations
- Parental animals: Observations and examinations:
- Deaths, morbidity and gross signs of toxicity were recorded twice daily, with at least 5 hr between observations. Individual body weights for the F 0 rats were measured weekly for the first 14 wk, bi-weekly for the next 12 wk, and then every 4 wk thereafter. Detailed physical examinations for signs of toxicity and palpation for masses were conducted weekly. Ophthalmoscopic examinations were conducted on all rats once during the F 0 generation, and at in- itiation, and months 3, 6, 12, 18 and 24 of the chronic phase.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- Two F0 female control rats died during the in utero phase of the original study, and one male and one female from the control and 5.0% group, respectively, died during the in utero phases of the high-dose study.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Slight decreases in body weight (4-5%) was noted in the F0 rats treated at a dietary level of 5.0%.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Slight increases in food consumption was noted in the F0 rats treated at a dietary level of 5.0%.
- 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:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- no effects observed
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity (P0)
- Critical effects observed:
- no
- Lowest effective dose / conc.:
- 5 other: %
- System:
- other: -
Results: P1 (second parental generation)
General toxicity (P1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- At the termination of the study 128 rats from the original study and 58 from the high-dose study were killed, whereas 472 rats from the original study and 182 rats from the high-dose study were killed in extremis, or died spontaneously or accidentally during the studies. There were no compound-related effects on the number of rats surviving.Increased mortality among the male rats of control group 1 and female rats of the 1.0% group resulted in the termination of the original study at wk 113 and 114 for males and females, respectively. The mortality among these two groups appeared to be random and not associated with the consumption of the tested substance.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Group mean body weights at termination were generally similar for control and treated rats in the original study except for males and females at the 1.0% dietary level in which decreases in group mean body weights were noted. The difference between the females treated at the 1.0% level and the controls was statistically significant (P <0.01). The rats (both male and female) from the high-dose study exhibited a statistically significant decrease in group mean body weights at termination.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- Food consumption was similar for control and treated rats in the original study. Food consumption among the high-dose rats was generally higher than that of the controls although the increases were not statistically significant.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Ophthalmoscopic examinations at most examination intervals revealed focal and diffuse retinopathy, conjunctivitis, uveitis, and cataracts in rats of all groups. None of these findings was compound related.
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- Few of the haematological, clinical chemistry and urinalysis parameters differed significantly between the control and treated animals, and none of the differences appeared to be compound related.
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Localized hair loss (due to friction against the cage) and nasal and ocular discharge occurred in low incidence throughout the study and were similarly distributed in control and treated rats. A yellow tint to the fur was noted in all treated animals and the faeces of the 1.0, 2.0 and 5.0% treated rats were yellow
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- In the ten rats of each sex from each group killed and necropsied after 1 yr on test in both studies, there were no compound-related gross or microscopic changes.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Histological evaluation revealed a variety of lesions, including neoplasms among the control and treated rats in the original and high-dose studies. These lesions were present in similar incidences in control and treated rats and appeared to be spon- taneous (Table 5). None of the lesions were determined to be related to the administration of the tested substance.
- Other effects:
- not specified
Reproductive function / performance (P1)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P1)
- Dose descriptor:
- NOAEL
- Effect level:
- 5 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Remarks on result:
- other: 2641 mg/kg bw
Results: F1 generation
General toxicity (F1)
- Mortality / viability:
- mortality observed, non-treatment-related
- Description (incidence and severity):
- There were no compound-related effects on pup survival.
- Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The mean body weights of the pups in the 5.0% group at lactation day 21 were slightly lower than those of the controls, although the differences were not statistically significant. There were no compound-related effects on pup survival.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 5 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Overall reproductive toxicity
open allclose all
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 2 641 other: mg/kg bw Male
- Treatment related:
- yes
- Reproductive effects observed:
- no
- Lowest effective dose / conc.:
- 3 348 other: mg/kg bw Female
- Treatment related:
- yes
Any other information on results incl. tables
A 2-generation chronic toxicity/carcinogenicity study was conducted with different concentrations of Acid Yellow 23. Male and female rats were fed a basal diet (control group) or basal diet blended
with commercial Acid Yellow 23 (0.1, 1.0, 2.0, 5.0 %) for approx. 2 months prior to mating. No treatment-related effects on fertility, gestation, parturition, lactation, pup survival through weaning or number of alive and still-born pups were observed. Slight decreases in body weight (4-5 %), and slight increases in food consumption were noted at the 5.0 % dose group.
The NOAEL for reproductive and teratogenic toxicity of Acid Yellow 23 was 5 % in the diet.
Applicant's summary and conclusion
- Conclusions:
- Not toxic for reproduction.
NOAEL = 2641 mg/kg bw (male)
NOAEL = 3348 mg/kg bw (female) - Executive summary:
Lifetime exposure of rats to the tested substance as a dietary admixture at levels up to 5.0% did not demonstrate toxic effects.
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.