Registration Dossier
Registration Dossier
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EC number: 229-054-5 | CAS number: 6408-31-7
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from EFSA
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Scientific Opinion on the re-evaluation Tartrazine (E 102)
- Author:
- European Food Safety Authority (EFSA)
- Year:
- 2 009
- Bibliographic source:
- EFSA Journal 2009; 7(11):1331
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Reproductive toxicity of 3-carboxy-5-hydroxy-1-(4'-sulphophenyl)-4-(4'-sulphophenylazo) pyrazole trisodium salt in Rats
- 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
- Reference substance name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo) pyrazole-3-carboxylate
- IUPAC Name:
- trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo) pyrazole-3-carboxylate
- Details on test material:
- - Name of test material (as cited in study report): Tartrazine
- Molecular formula (if other than submission substance): C16H12N4O9S2.3Na.
C16-H9-N4-O9-S2.3Na
- Molecular weight (if other than submission substance): 534.3681 g/mol
- Substance type: Organic
- Physical state: No data available
Purity No data available
- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - 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): 534.3681 g/mol
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- not specified
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 19 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
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:
- Not specified
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not specified
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Not specified
- Oestrous cyclicity (parental animals):
- Number and type of implantations were observed
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Not specified
- Postmortem examinations (parental animals):
- Not specified
- Postmortem examinations (offspring):
- External, skeletal and visceral development were examined.
- Statistics:
- Not specified
- Reproductive indices:
- Not specified
- Offspring viability indices:
- Fetal viability was observed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- 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
- 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 effect on Number and type of implantations were observed in treated rats.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- reproductive performance
- Remarks on result:
- other: No effect observed
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 effect on fetal viability were observed
- 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:
- no effects observed
- Description (incidence and severity):
- No effect on gross pathology of fetus observed as compared to control.
- Histopathological findings:
- no effects observed
- Description (incidence and severity):
- No effect on Fetal skeletal and visceral development were observed as compared to control.
- Other effects:
- not specified
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
- gross pathology
- histopathology: non-neoplastic
- Remarks on result:
- other: No effect observed
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
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg/day for P and F1 generation when Osborne-Mendel female rats treated with 3-carboxy-5-hydroxy-1-(4'- sulphophenyl)-4-(4'-sulphophenylazo) pyrazole trisodium salt orally by gavage for 19 days.
- Executive summary:
In a reproductive toxicity study,Osborne-Mendel female rat were treated with 3-carboxy-5-hydroxy-1-(4'- sulphophenyl)-4-(4'-sulphophenylazo) pyrazole trisodium salt in the concentration of 0, 60, 100, 200, 400, 600, or 1000 mg/kg bw/day orally by gavage for 19 days.Number and type of implantations were observed in treated rats. Similarly, No effects on fetal viability, gross pathology, Fetal skeletal and visceral development were observed as compared to control. Therefore, NOAEL was considered to be 1000 mg/kg/day for P and F1 generation when Osborne-Mendel female rats treated with 3-carboxy-5-hydroxy-1-(4'- sulphophenyl)-4-(4'-sulphophenylazo) pyrazole trisodium salt orally by gavage for 19 days.
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