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EC number: 209-608-2 | CAS number: 587-98-4
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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:
- Metanil Yellow Impairs the Estrous Cycle Physiology and Ovarian Folliculogenesis in Female Rats
- Author:
- Partha Pratim Nath, Kaushik Sarkar, Mukti Mondal, Goutam Paul
- Year:
- 2 016
- Bibliographic source:
- Environmental Toxicology (2016), 31(12), 2057-2067
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Evaluation of the toxic effects of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate on the female reproductive system.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium 3-(p-anilinophenylazo)benzenesulphonate
- EC Number:
- 209-608-2
- EC Name:
- Sodium 3-(p-anilinophenylazo)benzenesulphonate
- Cas Number:
- 587-98-4
- Molecular formula:
- C18H14N3O3S.Na
- IUPAC Name:
- sodium 3-(p-anilinophenylazo)benzenesulphonate
- Test material form:
- solid
- Details on test material:
- - Name of test material: Ext. D&C Yellow No. 1
- IUPAC name: sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula: C18H15N3O3SNa
- Molecular weight: 375.383 g/mol
- Substance type: organic
- Physical state: solid
- Purity: No data available
- Impurities (identity and concentrations): no data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula : C18H14N3O3S.Na
- Molecular weight: 375.383 g/mol
- Smiles notation : c1(Nc2ccccc2)ccc(\N=N\c2cc(ccc2)S(=O)(=O)[O-])cc1.[Na+]
- InChl : 1S/C18H15N3O3S.Na/c22-25(23,24)18-8-4-7-17(13-18)21-20-16-11-9-15(10-12-16)19-14-5-2-1-3-6-14;/h1-13,19H,(H,22,23,24);/q;+1/p-1/b21-20+;
- Substance type: Organic
- Physical state: Solid
Test animals
- Species:
- rat
- Strain:
- other: Charles Foster
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory-bred
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 90–120 days
- Weight at study initiation: between 110 and 120 g
- Fasting period before study: No
- Housing: Yes
- Use of restrainers for preventing ingestion (if dermal): not applicable
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature of 258C628C
- Humidity (%): not specified
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12:12 h light and dark cycle
IN-LIFE DATES: From: To: not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- No data
- Details on mating procedure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 and 30 days
- Frequency of treatment:
- daily
- Details on study schedule:
- no data
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- Dose / conc.:
- 500 mg/kg bw/day
- Dose / conc.:
- 750 mg/kg bw/day
- No. of animals per sex per dose:
- 4 groups of 8 female rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- no data
- Positive control:
- Not specifed
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: No data
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No
- Time schedule:
BODY WEIGHT: No
- Time schedule for examinations:
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: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
- Time schedule for examinations:
OTHER: - Oestrous cyclicity (parental animals):
- Yes
- Sperm parameters (parental animals):
- No
- Litter observations:
- No
- Postmortem examinations (parental animals):
- SACRIFICE
After completion of treatment period, the animals were sacrificed by cervical dislocation.
GROSS NECROPSY
Yes
HISTOPATHOLOGY / ORGAN WEIGHTS
Yes - Postmortem examinations (offspring):
- No
- Statistics:
- Data obtained from the results were expressed as mean-6SEM. Statistical comparisons between the values obtained in control and in treated rats were carried out by using ANOVA followed by Student’s t test and Mann–Whitney U test for non-parametric data whichever is applicable. p<=0.05 was considered as significant.
- Reproductive indices:
- Diestrus index = number of day with clear diestrus smear / total duration of treatment x 100
- Offspring viability indices:
- No data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not specified
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The level of LH, FSH, and estradiol were significantly decreased in the MY-treated rats compared to control rats. The activities of some antioxidants enzymes in brain tissues of MY-treated rats were significantly decreased and the level of malondialdehyde (MDA), a marker of lipid peroxidn., in brain tissues of MY-treated rats was also significantly increased.
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Light microscopic observations of brain tissue sections from treated rats showed mild structural changes in the brain tissues. Section studied from the cerebellum of control rats showed intact granule and purkinje cell layers. But in case of treated rats of higher doses in both treatment durations, a little dispersion was observed between granule cell layer and purkinje cell layer.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment with higher doses of MY (500 and 750 mg/ kg bw/ day) caused a significant decrease in the number of estrous cycle and duration of proestrus, estrous, and metestrus phases with a concomitant significant increase in duration of diestrus phases in both 20 and 30 days treatment
duration. Diestrus index was also increased dose dependently following the administration of MY. In case of 250 mg/ kg bw/ day MY-treated rat, these alterations were the same but not as significant as higher doses. Significant changes in the cellular characteristics of vaginal smear in component phases of estrous cycle in treated group of rats compared to control rats. - Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- Sexual maturity: The control rats exhibit an average GSI, while the treated group of rats showed less GSI according to the higher doses of treatment. We observed significant (p<0.05) decrease in the GSI in treated group of rats compared to control rats higher doses in both treatment durations, a little dispersion was observed between granule cell layer and purkinje cell layer.
Ovarian folliculogenesis in this study was also significantly impaired
Effect levels (P0)
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical biochemistry
- gross pathology
- neuropathology
- reproductive function (oestrous cycle)
- reproductive performance
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 250 mg/kg bw/day
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The Lowest observed effect concentration (LOAEL) value for the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate to female Charles Foster rats, after 20 and 30 exposure duration, was considered to be 250 mg/kg bw/day on the basis of observed effects on Clinical biochemistry, Estrous cycle, Reproductive performance, sexual maturity , gross pathology and histopathology.
- Executive summary:
The study was designed to examine the effect of test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Metanil yellow - MY) on estrous cycle rhythmicity and ovarian folliculogenesis in female rats. Rats have been exposed to MY at three doses of 250, 500, 750 mg/kg bw/day for two exposure durations, 20 and 30 days. Significant changes in the number and duration of estrous cycle along with prominent cytoarchitectural changes in the cellular characteristics of vaginal smear of component phases of estrous cycle in a dose and duration-dependent manner were observed in MY-treated rats compared to control rats. A significant decrease was also observed in serum follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol levels in MY-treated rats. Further, the activities of some antioxidants enzymes in brain tissues of MY-treated rats were significantly decreased and the level of malondialdehyde (MDA), a marker of lipid peroxidation, in brain tissues of MY-treated rats was also significantly increased. The ovarian folliculogenesis in this study was also significantly impaired in MY treated rats. In conclusion, MY impairs the estrous cycle and ovarian folliculogenesis in female rats by inhibiting the secretion of FSH and estradiol from the ovary, and inducing the oxidative stress in hypothalamic-pituitary-gonadal axis.
Hence, the Lowest observed effect concentration (LOAEL) value for the test substancesodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate to female Charles Foster rats, after 20 and 30 exposure duration, was considered to be250 mg/kg bw/day on the basis of observed effects on Clinical biochemistry, Estrous cycle, Reproductive performance, sexual maturity , gross pathology and histopathology.
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