Registration Dossier
Registration Dossier
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EC number: 217-699-5 | CAS number: 1934-21-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- No information on the guideline.
- GLP compliance:
- not specified
- Remarks:
- No information on the publication
- Test type:
- acute toxic class method
- Limit test:
- yes
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:
- mouse
- Strain:
- Swiss
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Supplier: C.E.R Janvier, Laval, FranceAge: 6 weeksRats were caged singly in plastic cage and housed in fully air-conditioned rooms with temperature = 19-23°C and humidity continuosly recorded. Animals were subjected to 12 hours artificial light and 12 hours darkness in each 24 hours period. Feeding: ad libitum coomercial pellet diet (A04, SAFE, Villemoisson, France)Drinking water: tap water ad libitumAcclimatization: one week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- doubly distilled
- Details on oral exposure:
- The tested substance was dissolved in waterPositive control: DAB dimethylaminoazobenzene dissolved in olive oilNegative control: water and oil
- Doses:
- 20, 200 and 1000 mg/kg bw
- No. of animals per sex per dose:
- 7 animals per group
- Control animals:
- no
- Details on study design:
- Mice were given a double dose of tartrazine, 24 h apart and were killed 24 hours after the last dosing.
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No data
- Gross pathology:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The tested item was found to be non-toxic for oral exposure with a LD50 > 1000 mg/kg bw.
- Executive summary:
The acute oral toxicity test of Acid Yellow 23 in mice showed a LD50 value was > 1000 mg/kg.
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