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EC number: 208-253-0 | CAS number: 518-47-8
- 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
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Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- THE TERATOGENIC POTENTIAL IN RATS AND RABBITS OF D&C YELLOW NO. 8
- Author:
- C. M. BURNETI, E. I. GOLDENTHAL
- Year:
- 1 986
- Bibliographic source:
- Fd Chem. Toxic, Vol. 24, No. 8, pp. 819 823, 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- Teratogenic toxicity study of D&C YELLOW NO. 8 in rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate
- EC Number:
- 208-253-0
- EC Name:
- Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate
- Cas Number:
- 518-47-8
- Molecular formula:
- C20H12O5.2Na
- IUPAC Name:
- disodium 3-oxo-3H-spiro[2-benzofuran-1,9'-xanthene]-3',6'-diolate
- Reference substance name:
- D&C YELLOW NO. 8
- IUPAC Name:
- D&C YELLOW NO. 8
- Details on test material:
- - Name of test material (as cited in study report): D & C Yellow No. 8, sodium fluorescein (C.I. No. 45350)
- Molecular formula (if other than submission substance): C20H12O5.2Na
- Molecular weight (if other than submission substance): 376.274 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): 13 %
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 18 weeks
- Weight at study initiation: 246 to 379 g
- Fasting period before study: No data available
- Housing: Animals were housed individually and identified by ear tag.
- Diet (e.g. ad libitum): Purina Certified Rodent Chow No. 5002, ad libitum
- Water (e.g. ad libitum): water, ad lib.
- Acclimation period: 4 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.22 ± 15
- Humidity (%):50 ± 15%
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 12-hr light/dark cycle.
IN-LIFE DATES: From: To: No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Doses were prepared daily in an aqueous solution at 100, 500 or 1500 mg/kg body weight.
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): Water
- Concentration in vehicle: 0, 100, 500 or 1500 mg/kg body weight.
- Amount of vehicle (if gavage): 10 ml/kg
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 100, 500 or 1500 mg/kg body weight.
Basis:
nominal in water
- No. of animals per sex per dose:
- Total: 100
0 mg/kgbw/day:25 female
100 mg/kgbw/day:25 female
500 mg/kgbw/day:25 female
1500 mg/kgbw/day:25 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: No data available
- Rationale for animal assignment (if not random): Mated females were assigned to the control group or to one of the three treatment groups of 25 animals each.
- Rationale for selecting satellite groups: No data available
- Post-exposure recovery period in satellite groups: No data available
- Section schedule rationale (if not random): No data available
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
- Cage side observations checked in table [No.?] were included: Survival was observed.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: On days 6, 9, 12 and 16 of gestation
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: Yes
The thoracic and abdominal cavities and the internal organs of the dams were examined for gross morphological changes.
HISTOPATHOLOGY: No data available - Other examinations:
- The number and location of viable and non-viable foetuses, early and late resorptions, total implantations and corpora lutea were recorded.
- Statistics:
- Statistical analysis were performed by using Chi-square test criterion with Yates" correction for 2 x 2 contingency lables and, or Fisher's exact probability test as described by Sicgel (1956) to Differences in the foetal sex distribution and the number of litters with malformations between control and treated groups. The numbers of early and late resorptions, dead foetuses and post-implantation losses were compared between groups by the Mann Whitney U test as described by Siegel (1956) and Well (1970). The mean numbers of viable foetuses, total implantations, corpora lutca and mean foetal weights were compared between groups by analysis of variance (one way classification), Bartlett's test for homogeneity of variances, and the appropriate t- test (for equal or unequal variances) as described by Steel & Torric (1960) using Dunnctt's multiple comparison tables (1964).
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- 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:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- not specified
- Details on results:
- Mortality :
When treated with 1500 mg/kg bw/day, Six rats died during the dosing period as compared to control.
Clinical signs:
Orange discoloration of the urine was observed in all the treated rats as compared to control.
Body weight and weight gain When treated with 1500 mg/kg bw/day, decrease in body weight gain was observed in treated rats as compared to control.
Food consumption and compound intake No data available
Food efficiency No data available
Water consumption and compound intake: No data available
Opthalmoscopic examination No data available
Haematology: No data available
Clinical chemistry: No data available
Urinanalysis: No data available
Neurobehaviour: No data available
Organ weights No data available
Gross pathology: When treated with 1500 mg/kg bw/day, green discoloration of the amniotic fluid and green colored small intestines were observed in treated rats as compared to control.
When treated with 100 and 500 mg/kg bw/day, green discoloration of the amniotic fluid was observed in treated rats as compared to control.
Histopathology No data available
Details on results:
There were no biologically meaningful or statistically significant differences in the number of litters and number of fetuses with malformations, number of foetuses or litters with developmental variations in any of the treated groups.
At 1500 mg/kg be/day, slight increase in the number of litters with unossified sternebrae (sternebrae nos 1-6) and rudimentary 14th rib(s) was observed as compared to control. However, these values fell within the ranges of historical control data.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No effect on survival, clinical sign, body weight and body weight gain, gross pathology and reproductive performances
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mean maternal body weights for rats given D & C Yellow No. 8 by gavage on days 6-19 of gestation
|
|
Mean maternal body weights (g) |
|||
Day of gestation |
Dose (mg kg / day) |
0 (control) |
100 |
500 |
1500 |
0 |
|
246± 145 |
249 ± I3.7 |
249± 14.7 |
241± 12.4 |
6 |
|
272 ± 16.8 |
271 ± 14.4 |
276± 14.5 |
263 ±12.2 |
9 |
|
279+ 18,1 |
278 ± 15.9 |
283 ± 16.7 |
269 ± 16.5 |
12 |
|
294 ± 20.1 |
292 ± 17.5 |
296 ± 16.1 |
282 ± 16.9 |
16 |
|
321 ± 23.4 |
320 ± 18.9 |
323 ± 20.4 |
300 ± 30.7 |
20 |
|
379 ± 30.0 |
378 ± 21.2 |
374 + 32.2 |
359 ± 33.3 |
Mean maternal body-weight changes in rats given D & C Yellow No. 8 on days 6 -19 of gestation
|
|
Mean maternal body weights (g) |
|||
Day of gestation |
Dose (mg kg / day) |
0 (control) |
100 |
500 |
1500 |
0 -6 |
|
26 |
22 |
27 |
22 |
6 -9 |
|
7 |
7 |
7 |
6 |
9 -12 |
|
15 |
14 |
13 |
13 |
12 -16 |
|
27 |
28 |
27 |
18 |
16 -20 |
|
58 |
58 |
51 |
59 |
6-20 |
|
107 |
107 |
98 |
06 |
0-20 |
|
133 |
129 |
125 |
118 |
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 500 mg/kg body weight /day when CD Sprague-Dawley female rats were treated with D&C YELLOW NO. 8.
- Executive summary:
In a Teratogenic toxicity study, CD Sprague-Dawley female rats were treated with D&C YELLOW NO. 8 in the concentration of 0, 100, 500 and 1500 mg/kg body weight/ day by oral gavage.Six rats died during the dosing period at 1500 mg/kg bw/day and Orange discoloration of the urine was observed in all the treated rats as compared to control. Similarly, green discoloration of the amniotic fluid and green colored small intestines were observed at 1500 mg/kg bw/day and green discoloration of the amniotic fluid was observed at 100 and 500 mg/kg bw/day treated rats as compared to control. In addition, slight increase in the number of litters with unossified sternebrae (sternebrae nos 1-6) and rudimentary 14th rib(s) were observed as compared to control. However, these values fell within the ranges of historical control data. There were no biologically meaningful or statistically significant differences in the number of litters and number of fetuses with malformations,number of foetuses or litters with developmental variations in any of the treated groups. Therefore, NOAEL was considered to be 500 mg/kg body weight /day when CD Sprague-Dawley female rats were treated with D&C YELLOW NO. 8 orally by gavage from day 6 to 19 of gestation.
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