Registration Dossier
Registration Dossier
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EC number: 260-925-2 | CAS number: 57741-47-6
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- 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 secondary source.
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Reports of the Scientific Committee on Cosmetology (seventh series)
- Author:
- Scientific Committee on Cosmetology
- Year:
- 1 988
- Bibliographic source:
- Environment, Consumer Protection and Nuclear Safety, ISBN 92-825-8129-2, 1988, page no 37
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Chronic repeated dose oral toxicity study of Disodium salt of 8-amino-2-phenyLazo-1-naphtol-3,6-disulphonic acid in dogs
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 222-656-9
- EC Name:
- Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3567-66-6
- Molecular formula:
- C16H13N3O7S2.2Na
- IUPAC Name:
- disodium 5-amino-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- D&C Red 33
- IUPAC Name:
- D&C Red 33
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Disodium saLt of 8-amino-2-phenyLazo-1-naphtoL-3,6-disuLphonic acid
- Molecular formula (if other than submission substance): C16H11N3Na2O7S2
- Molecular weight (if other than submission substance): 467 g/mole
- Substance type: Organic
- Physical state: Powder
- Impurities (identity and concentrations): No data available
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Details on test material
- Name of test material (as cited in study report): - D&C Red No. 33
- Molecular formula (if other than submission substance): C16-H13-N3-O7-S2.2Na
- Molecular weight (if other than submission substance): 467.3889 g/mol
- Substance type: Organic
Test animals
- Species:
- dog
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data available
- Age at study initiation: No data available
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: No data available
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data available
- Concentration in vehicle: 3.0% (750 mg/kg bw/day)
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
750 mg/kg bw/day
- No. of animals per sex per dose:
- Total number of animals -2
- Control animals:
- not specified
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data available
- Cage side observations checked in table [No.?] were included: No data available
DETAILED CLINICAL OBSERVATIONS: No data available
- Time schedule: No data available
BODY WEIGHT: No data available
- Time schedule for examinations: No data available
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data available
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data available
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data available
FOOD EFFICIENCY: No data available
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available
- Time schedule for examinations: No data available
OPHTHALMOSCOPIC EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
HAEMATOLOGY: No data available
- Time schedule for collection of blood: No data available
- Anaesthetic used for blood collection: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
CLINICAL CHEMISTRY: No data available
- Time schedule for collection of blood: No data available
- Animals fasted: No data available
- How many animals: No data available
- Parameters checked in table [No.?] were examined. No data available
URINALYSIS: No data available
- Time schedule for collection of urine: No data available
- Metabolism cages used for collection of urine: No data available
- Animals fasted: No data available
- Parameters checked in table [No.?] were examined. No data available
NEUROBEHAVIOURAL EXAMINATION: No data available
- Time schedule for examinations: No data available
- Dose groups that were examined: No data available
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data available
OTHER: No data available - Sacrifice and pathology:
- GROSS PATHOLOGY: No data available
HISTOPATHOLOGY: No data available - Other examinations:
- No data available
- Statistics:
- No data available
Results and discussion
Results of examinations
- Clinical signs:
- 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
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Changes in Liver, kidneys and thyroid were observed in treated dogs.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 750 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed at this dose
Target system / organ toxicity
- Critical effects observed:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 750 mg/kg bw/day when dogs were treated with Disodium salt of 8-amino-2-phenylazo-1-naphtol-3, 6-disulphonic acid for 90 days.
- Executive summary:
In a chronic repeated dose toxicity study, dogs were treated with Disodium salt of 8-amino-2-phenylazo-1-naphtoL-3, 6-disulphonic acid in the concentration of 750 mg/kg bw/day orally in diet. Histopathological changes in the Liver, kidneys and thyroid were observed in 750 mg/kg/day treated dogs No other effect in clinical sign, mortality ,morbidity were observed at this dose. Therefore, NOAEL was considered to be 750 mg/kg bw/day when dogs were treated with Disodium salt of 8-amino-2-phenyLazo-1-naphtoL-3, 6-disuLphonic acid orally for 90 days.
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