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EC number: 232-318-2 | CAS number: 8003-22-3 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 47000.
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data available from study report.
- Qualifier:
- according to guideline
- Guideline:
- other: Data is from Journal with permission
- Principles of method if other than guideline:
- Reproductive toxicity study of D&C Yellow No. 11 orally in rat orally
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
Source: Taconic Farms (Germantown, NY)
- Age at study initiation: (P) Thirty-two-day-old male and female(F0)
-(F1) x wks: No data 42 days
- Age at study initiation: (P) 112 days old
- Weight at study initiation: (P) No data available
- Fasting period before study: No details available
- Housing: Rats were housed five per cage
Animals were housed in Solid-bottom polycarbonate changed twice weekly except from day 18 of gestation through delivery. Animals were bedded on Sani-Chips changed twice weekly except from day 18 of gestation through delivery. Reemay® spun-bonded polyester Rack Filters changed once every 2 weeks except from day 18 of gestation through delivery Stainless steel changed once every 2 weeks except from day 18 of gestation through delivery. Identified by Tail tattoo. Animals were housed 5 per cage before cohabitation, 1 pair during cohabitation and 5 males or 1 dam and litter aafter cohabitation.
- Use of restrainers for preventing ingestion (if dermal): No details
- Diet : NIH-07 open formula mash ad libitum
Water: : Tap water via automatic watering system, ad libitum
- Acclimation period: Animals were quarantined for 10 Days
ENVIRONMENTAL CONDITIONS
Temperature (°C): 20.0-25.6’c
Humidity :23.3% to 81.2%
- Air changes (per hr): minimum of 10 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours/day
IN-LIFE DATES:
From: 18 December 1989
To: male: 13 March 1990
Female: 24 april 1990- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: NIH-07 open formula mash
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: Dose were prepared by mixing D&C Yellow No. 11 in the concentration of 0, 500, 1,700, and 5,000 ppm with NIH-07 open formula mash feed. D&C Yellow No. 11/feed premix was made by hand and then blended with feed in a Patterson-Kelly twin-shell blender for 15 minutes with the intensifier bar on for the first 5 minutes.
- Rate of preparation of diet (frequency): every 2 weeks
- Mixing appropriate amounts with (Type of food):The dose formulations were prepared every 2 weeks by mixing D&C Yellow No. 11 with feed (Table G1). A D&C Yellow No. 11/feed premix was made by hand and then blended with feed in a Patterson-Kelly twin-shell blender for 15 minutes with the intensifier bar on for the first 5 minutes. 0, 500, 1,700, and 5,000 ppm in NIH-07 open formula mash feed.
- Storage temperature of food:During the studies, dose formulations were stored in double-thickness plastic bags in rigid plastic containers at room temperature protected from light for up to 3 weeks.
VEHICLE
- Justification for use and choice of vehicle (if other than water): NIH-07 open formula mash feed
- Concentration in vehicle: 0, 500, 1,700, and 5,000 ppm
- Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- - M/F ratio per cage: During cohabitation -one male and one female per cage
- Length of cohabitation: 7 days
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy
During cohabitation, vaginal smears were taken daily from females to determine the presence of sperm.
- After ... days of unsuccessful pairing replacement of first male by another male with proven fertility. No data
- Further matings after two unsuccessful attempts: [no / yes (explain)] No data
- After successful mating each pregnant female was caged (how): 1 dam per cage
- Any other deviations from standard protocol:
Analytical verification of doses Yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Homogeneity and stability studies of the 500 ppm dose formulation were performed by the analytical chemistry laboratory using high-performance liquid chromatography. Homogeneity was confirmed and the stability of the dose formulations was confirmed for at least 3 weeks when stored protected from light at room temperature and for 7 days when stored open to air and light. Periodic analyses of the dose formulations of D& C Yellow No. 11 were ferpormed by using visible spectrometry. During the reproductive study the formulations wer e analyzed approximately every 8 weeks.
- Duration of treatment / exposure:
- Total: 125 weeks
Male: 13 weeks
Female: 19 weeks
F1: 106 week - Frequency of treatment:
- Daily
- Details on study schedule:
- First-generation (F0 ) rats started on D&C Yellow No. 11 in feed---->70-day precohabitation period---->7-day cohabitation period---->21-day gestation period---->28-day lactation period---->Second-generation (F1 ) rats continued on same concentrations of D&C Yellow No. 11 in feed as dams for 2 years---->Terminal sacrifice
- Remarks:
- Doses / Concentrations:
0, 500, 1,700 and 5,000 ppm (0, 35, 120 and 350 ma/kg body weight /day for male and 0, 35, 120 and 370 ma/kg body weight /day for female )
Basis:
nominal in diet - No. of animals per sex per dose:
- Total: 480
0 ppm : 60 male, 60 female
25 ppm : 60 male, 60 female
85 ppm : 60 male, 60 female
250 ppm : 60 male, 60 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: The results of the 13-week rat study were used to select doses of 500, 1,700, and 5,000 ppm for the current F344/N rat study. In the 13-week feed study, rats were given 500, 1,700, 5,000, 17,000 and 50,000 ppm. There was no perinatal exposure, and animals were about 6 weeks old when placed on dosed feed. Mean body weights of males and females were significantly reduced after 13 weeks of exposure to 17,000 and 50,000 ppm, and there was mild hepatocellular periportal degeneration in 7 males given 17,000 ppm, in all 10 given 50,000 ppm, and in 2 females given 50,000 ppm. This lesion was minimal at doses of 1,700 and 5,000 ppm in males (4/4, 9/10) and females (2/2, 7/7) and in females at 17,000 ppm (9/10) and was not observed in groups given 500 ppm. In addition, a range-finding study was conducted in which female rats were given 5,000, 17,000, or 50,000 ppm D&C Yellow No. 11 in feed for 4 weeks before mating and during mating, gestation, and the first 4 weeks after having litters. Pups were weaned at week 4 and continued on the same feed as their dams for an additional 4 weeks. Litters would have been potentially exposed in utero, through lactation, and feed. There was no difference between study groups in reproductive performance. However, pup body weights in the 17,000 and 50,000 ppm groups were decreased at 8 weeks of age. Microscopic evaluation showed that the liver lesions in exposed pups were similar to those described for the 13-week study.
- Rationale for animal assignment (if not random): Rats were distributed randomly into groups of approximately equal initial mean body weights.
- Other: No data available - Positive control:
- No data
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice daily
- Cage side observations checked in table [No.?] were included: Mortality were observed.
DETAILED CLINICAL OBSERVATIONS: Yes clinical findings on day one and weekly before cohabitation for F0 Males and Females And on day 0, 6, 15 and 21of gestation for females & on days 1, 4, 14, and 21 of lactation for F females and F1 pups.
BODY WEIGHT: Yes on day one and weekly before cohabitation for F0 Males and Females And on day 0, 6, 15 and 21of gestation for females & on days 1, 4, 14, and 21 of lactation for F females and F1 pups.
Feed consumption was recorded by cage weekly before cohabitation, ondays 0, 6, 15, and 21 during gestation, and on days 1, 4, 14, and 21 during lactation.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data available - Oestrous cyclicity (parental animals):
- Any irregularities in the estrous cycle were investigated.
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- Survival, clinical sign, number and sex of pups, body weight, feed consumption were examined.
- Postmortem examinations (parental animals):
- HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated were prepared for microscopic examination and weighed, respectively-Yes - Postmortem examinations (offspring):
- Hematology, Organs weighed and histopathology were examined.
- Statistics:
- Body weight data for F rats, maternal body weight data during gestation and lactation, litter weight data, pup delivery data, percent male pups, and pups surviving on days 4 and 21 were analyzed by using Williams’ or Dunnett’s test. Feed consumption data for F0 rats were analyzed by using Dunn’s or Shirley’s test.
- Reproductive indices:
- Fertility index and implantation sites were examined.
- Offspring viability indices:
- Viability on day 4 were observed
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance intake: Dietary levels of 500, 1,700, and 5,000 ppm D&C Yellow No. 11 resulted in average daily doses of approximately 35, 120, and 350 mg /kg body weight for males and 35, 120, and 370 mg/kg for females.
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effect were observed on Reproductive function of treated rat as compared to control.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effect were observed on Reproductive performance of treated rat as compared to control.
- Dose descriptor:
- NOAEL
- Effect level:
- 35 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effect on survival, clinical sign, body weight and body weight gain, food consumption and compound intake
- Remarks on result:
- other: not specified
- 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
- Clinical signs:
- effects observed, treatment-related
- Mortality / viability:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Significant increase in absolute and relative liver weights were observed in all the treated pups as compared to control.
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings:
- effects observed, treatment-related
- Dose descriptor:
- LOAEL
- Generation:
- F1
- Effect level:
- 25 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect on organ weight, gross pathology and histopathology
- Remarks on result:
- other: not specified
- 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
- 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
- Conclusions:
- The no observed adverse effect level (NOAEL) for F0 generation was considered to be 500 ppm (35 mg/kg body weight /day) and The Low observed adverse effect level (LOAEL) LOAEL for F1 generation was considered to be 500 ppm (25 mg/kg body weight /day) when F344/N male and female rats were treated with D&C Yellow No. 11.
- Executive summary:
In a reproductive toxicity study,F344/N male and female rats were treated with D&C Yellow No. 11. in the concentration of0, 500, 1,700 and 5,000 ppmorally in diet.Yellow discoloration of the entire body or fur and urine-stained abdominal fur. Significantly decreased in mean body weight gains ofF0males were observed at 500, 1,700 and 5,000 ppm. The mean body weights of exposed litters were significantly less than those of the control litters on days 14 and 21 in 1700 and 5000 ppm dose.In F1 generation, effect were observed as significant decreasein survival,Yellow discoloration of the entire bodyof pups, head swelling and edema in 1,700 and 5,000 ppm males pupsand Significant increase in absolute and relative liver weights were observed in all the treated pups as compared to control. In addition, Renal tubule adenomas, Hepatocellular adenoma in 1700 and 5,000 ppm treated males pups and Renal tubule adenomas, hepatocellular adenoma or carcinoma (combined) in 1700 and 5,000 ppm treated females pups, Squamous cell carcinomas of the tongue were observed in one 500 ppm male pup at 12 months and one 5,000 ppm female pup at 2 years, Renal tubule pigmentation in all the treated pups and Squamous cell papillomas of oral cavity (oral mucosa or tongue) in 1700 and 15000 ppm treated male pups were observed. Histopathological changes such as Mixed cell foci and clear cell foci in 1700 and 5000 ppm, Cytologic alterations (basophilia and granularity) o f hepatocytes, and pigmentation in bile duct epithelium, hepatocytes, and Kupffer cells in treated male and female pups, Necrosis and regeneration of the renal tubule epithelium in all the treated male and female pups and Hyperplasia of the transitional epithelium in the kidney of 1700 ppm treated male and female pups were observed as compared to control. Therefore,NOAEL for F0 generation was considered to be 500 ppm (35 mg/kg body weight /day) and LOAEL for F1 generation was considered to be 500 ppm (25 mg/kg body weight /day) when F344/N male and female rats were treated with D&C Yellow No. 11. Orally in diet for125 weeks.
Reference
Mortlity:
No effect were observed on survival of treated rat as compared to control.
Clinical signs:
Yellow discoloration of the entire body or fur in all males and females observed at 1,700 and 5,000 ppm dose and in all males and seven females at 500 ppm dose .
In all rats at 1,700 and 5,000 pp m, urine-stained abdominal fur were observed.
Yellow discoloration of the fur was observed in all exposed female rats during gestation and lactation as compared to control.
Body weight and food consumption:
Prior to cohabitation, mean body weight gains of males (days 1 to 71) at 500, 1,700 and 5,000 ppm and of females (days 1 to 66) at 5,000 ppm were significantly decreased as compared to controls.
The mean body weight gains of exposed females during gestation and lactation were generally similar to those of the controls
Mortlity:
When treated with 1700 and 5000 ppm , significant decrease were observed in survival of male pups and at 5000 ppm in female as compared to control.
Clinical signs:
Yellow discoloration of the entire body in all exposed male and female pups from day 1 and head swelling and edema in 1,700 and 5,000 ppm males pups were observed as compared to control.
Body weight:
The mean body weights of exposed pups were significantly less than those of the control litters on days 14 and 21 in 1700 and 5000 ppm dose group.
Food consumption:
No effect was observed on food consumption of treated pups as compared to control.
Test substance intake:
Dietar y levels of 500, 1,700, and 5,000 ppm D&C Yellow No. 11 resulted in average daily doses of approximately 25, 85, and 250 mg /kg body weight for males and 25, 100, and 280 mg/kg body weight for females.
Gross pathology:
Renal tubule adenomas, Hepatocellular adenoma in 1700 and 5,000 ppm treated males pups and Renal tubule adenomas, hepatocellular adenoma or carcinoma (combined) in 1700 and 5,000 ppm treated females pups were observed as compared to control.
Squamous cell carcinomas of the tongue were observed in one 500 ppm male pup at 12 months and one 5,000 ppm female pup at 2 years were observed.
Renal tubule pigmentation were observed in all the treated male and female pups as compared to control.
Squamous cell papillomas were observed in the oral cavity (oral mucosa or tongue) of 1700 and 15000 ppm treate male pups.
Histopathology:
Mixed cell foci and clear cell foci in 1700 and 5000 ppm treated male and female pups were observed.
Cytologic alterations (basophilia and granularity) o f hepatocytes, and pigmentation in bile duct epithelium, hepatocytes, and Kupffer cells in treated male and female pups were observed.
Necrosis and regeneration of the renal tubule epithelium were observed in all the treated male and female pups.
Hyperplasia of the transitional epithelium in the kidney of 1700 ppm treated male and female pups.
other findings:
Hematology:
Minimal anemia in all the treated males were observed ; this anemia was characterized by decreased hematocrit values, hemoglobin concentra tions, and erythrocyte counts.
Th e minimal anemia was characterized as normocytic , normochromic, and nonresponsive. Normocytic , normochromic, nonresponsive anemias have been related to selective suppression of erythropoiesis in a variety of disorders and may be due to decreased erythropoietin elaboration, bone marrow suppression, or defective iron metabolism.
Therefore, the observed effect is not biologically or statistically significant than control.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 35 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- K2 level data .
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
WoE Summary of 8003-22-3 for toxicity to reproduction
Based on the various studies available with Klimish rating 2 and predicted data for the target substances CAS: 8003-22-3 the results is summarized as follows:
Sr. No |
End point |
Value |
Species |
Effects |
Remarks |
1 |
NOAEL |
35 mg/kg bw/day (nominal) (P generation) |
Rat (male & female) |
No adverse effect on survival, clinical sign, body weight and body weight gain, food consumption and compound intake |
Data from study report for 8003-22-3 |
2 |
LOAEL |
25 mg/kg bw/day (nominal) (F1 generation) |
Rat (male & female) |
Effect on organ weight, gross pathology and histopathology |
Data from study report for 8003-22-3 |
3 |
NOEL |
85 mg/kg bw/day (nominal) (F1 generation) |
Rat (female) |
All the serological test results were negative for reproductive toxicity. |
Data from study report for 8003-22-3 |
4 |
LOAEL |
85 mg/kg bw/day (nominal) (F1 generation) |
Rat (male) |
All the serological test results were negative for reproductive toxicity. |
Data from study report for 8003-22-3 |
5 |
NOAEL |
829 mg/kg bw/day (actual dose received) |
Rat |
No effect observed on organ weight |
Data from Publication for 8003-22-3 |
6 |
NOEL |
751 mg/kg bw/day (actual dose received) |
Rat |
No effect observed on organ weight |
Data from Publication for 8003-22-3 |
Based on the studies summarized in the above table it can be observed that, the no observed adverse effect level (NOAEL) value found to be 35 mg/kg bw/day (nominal). While from predicted data NOAEL values predicted as 829 mg/kg bw/day (actual dose received). Also the NOEL value found to be 85 mg/kg bw/day (nominal). While from predicted data values predicted as 751 mg/kg bw/day (actual dose received).
In F1 generationthe Low observed adverse effect level (LOAEL) values found to be 25 mg/kg bw/day (nominal) and 85 mg/kg bw/day (nominal)
All the serological test results were negative for reproductive toxicity in the 35 mg/kg/day group in parent generation.
Thus based on above discussion it can be concluded that substance CAS: 8003-22-3 is considered to be not toxic to reproduction at the above mentioned dose.
Short description of key information:
The no observed adverse effect level (NOAEL) for F0 generation was considered to be 500 ppm (35 mg/kg body weight /day) and The Low observed adverse effect level (LOAEL) LOAEL for F1 generation was considered to be 500 ppm (25 mg/kg body weight /day) when F344/N male and female rats were treated with D&C Yellow No. 11.
Justification for selection of Effect on fertility via oral route:
Data available from study report.
For the reproductive toxicity study in rats, all serology test results were negative.No significant effects were observed as compared to control with respect to target chemical.
Effects on developmental toxicity
Description of key information
The developmental toxicity LOEL (Lowest Observed Effect Level) of D&C Yellow No. 11 in Sprague Dawley rat by the oral route was estimated to be 99.1999 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from QSAR Toolbox Version 3.3
- Justification for type of information:
- QSAR prediction: migrated from IUCLID 5.6
- Qualifier:
- according to guideline
- Guideline:
- other: The prediction is done using QSAR Toolbox version 3.3
- Principles of method if other than guideline:
- The prediction is done using QSAR Toolbox version 3.3
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sprague Dawley
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on exposure:
- No Data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No Data
- Details on mating procedure:
- No Data
- Duration of treatment / exposure:
- 21 days
- Frequency of treatment:
- Daily
- Duration of test:
- No Data
- No. of animals per sex per dose:
- No data available
- Details on study design:
- No data available
- Maternal examinations:
- No data available
- Ovaries and uterine content:
- No data available
- Fetal examinations:
- No data available
- Statistics:
- No data available
- Indices:
- No data available
- Historical control data:
- No data available
- Details on maternal toxic effects:
- Maternal toxic effects:no data
- Dose descriptor:
- other: not specified
- Based on:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Abnormalities:
- not specified
- Localisation:
- not specified
- Description (incidence and severity):
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no data
- Dose descriptor:
- LOEL
- Effect level:
- 99.2 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: fetotoxicity
- Remarks on result:
- other: not specified
- Abnormalities:
- not specified
- Localisation:
- other: not specified
- Description (incidence and severity):
- not specified
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- The developmental toxicity LOEL (Lowest Observed Effect Level) of D&C Yellow No. 11 in Sprague Dawley rat by the oral route was estimated to be 99.1999 mg/kg bw/day.
- Executive summary:
The developmental toxicity LOEL (Lowest Observed Effect Level) of D&C Yellow No. 11 in Sprague Dawley rat by the oral route was estimated to be 99.1999 mg/kg bw/day.
Reference
The
prediction was based on dataset comprised from the following
descriptors: LOEL
Estimation method: Takes average value from the 5 nearest neighbours
Domain logical expression:Result: In Domain
((((("a"
or "b" or "c" or "d" )
and ("e"
and (
not "f")
)
)
and (("g"
or "h" or "i" or "j" )
and ("k"
and (
not "l")
)
)
and (("m"
or "n" or "o" or "p" )
and ("q"
and (
not "r")
)
)
)
and ("s"
and (
not "t")
)
)
and ("u"
and "v" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Aryl AND Diketone AND Fused
carbocyclic aromatic AND Fused heterocyclic aromatic AND Indandione AND
Pyridine AND Quinoline/ Isoquinoline by Organic Functional groups
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Fused carbocyclic aromatic AND
Indandione AND Overlapping groups AND Quinoline/ Isoquinoline by Organic
Functional groups (nested)
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Aliphatic Carbon [CH] AND
Aromatic Carbon [C] AND Aromatic Nitrogen AND Carbonyl, aliphatic attach
[-C(=O)-] AND Carbonyl, olefinic attach [-C(=O)-] AND Carbonyl, one
aromatic attach [-C(=O)-] AND Miscellaneous sulfide (=S) or oxide (=O)
AND Olefinic carbon [=CH- or =C<] AND Tertiary Carbon by Organic
functional groups (US EPA)
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Aromatic compound AND Carbonyl
compound AND Ketone by Organic functional groups, Norbert Haider
(checkmol)
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OECD
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >>
Isocyanates and Isothiocyanates OR Acylation >> Isocyanates and
Isothiocyanates >> Isothiocyanates OR Acylation >> P450 Mediated
Activation to Isocyanates or Isothiocyanates OR Acylation >> P450
Mediated Activation to Isocyanates or Isothiocyanates >>
Benzylamines-Acylation OR Acylation >> P450 Mediated Activation to
Isocyanates or Isothiocyanates >> Formamides OR Acylation >> P450
Mediated Activation to Isocyanates or Isothiocyanates >> Sulfonylureas
OR Michael addition OR Michael addition >> P450 Mediated Activation of
Heterocyclic Ring Systems OR Michael addition >> P450 Mediated
Activation of Heterocyclic Ring Systems >> Furans OR Michael addition >>
P450 Mediated Activation of Heterocyclic Ring Systems >>
Thiophenes-Michael addition OR Michael addition >> P450 Mediated
Activation to Quinones and Quinone-type Chemicals OR Michael addition >>
P450 Mediated Activation to Quinones and Quinone-type Chemicals >> Alkyl
phenols OR Michael addition >> P450 Mediated Activation to Quinones and
Quinone-type Chemicals >> Arenes OR Michael addition >> P450 Mediated
Activation to Quinones and Quinone-type Chemicals >> Hydroquinones OR
Michael addition >> P450 Mediated Activation to Quinones and
Quinone-type Chemicals >> Methylenedioxyphenyl OR Michael addition >>
P450 Mediated Activation to Quinones and Quinone-type Chemicals >>
Polycyclic (PAHs) and heterocyclic (HACs) aromatic hydrocarbons-Michael
addition OR Michael addition >> Polarised Alkenes-Michael addition OR
Michael addition >> Polarised Alkenes-Michael addition >> Alpha, beta-
unsaturated amides OR Michael addition >> Polarised Alkenes-Michael
addition >> Alpha, beta- unsaturated esters OR Michael addition >>
Polarised Alkenes-Michael addition >> Alpha, beta- unsaturated ketones
OR Michael addition >> Quinones and Quinone-type Chemicals OR Michael
addition >> Quinones and Quinone-type Chemicals >> Quinones OR Schiff
base formers OR Schiff base formers >> Chemicals Activated by P450 to
Glyoxal OR Schiff base formers >> Chemicals Activated by P450 to
Glyoxal >> Ethanolamines (including morpholine) OR Schiff base formers
>> Chemicals Activated by P450 to Glyoxal >> Ethylenediamines
(including piperazine) OR Schiff base formers >> Chemicals Activated by
P450 to Mono-aldehydes OR Schiff base formers >> Chemicals Activated by
P450 to Mono-aldehydes >> Benzylamines-Schiff base OR Schiff base
formers >> Direct Acting Schiff Base Formers OR Schiff base formers >>
Direct Acting Schiff Base Formers >> Mono aldehydes OR SN1 OR SN1 >>
Carbenium Ion Formation OR SN1 >> Carbenium Ion Formation >> Allyl
benzenes OR SN1 >> Carbenium Ion Formation >> Diazoalkanes OR SN1 >>
Carbenium Ion Formation >> N-Nitroso (alkylation) OR SN1 >> Carbenium
Ion Formation >> Polycyclic (PAHs) and heterocyclic (HACs) aromatic
hydrocarbons-SN1 OR SN1 >> Iminium Ion Formation OR SN1 >> Iminium Ion
Formation >> Aliphatic tertiary amines OR SN1 >> Nitrenium Ion formation
OR SN1 >> Nitrenium Ion formation >> Aromatic azo OR SN1 >> Nitrenium
Ion formation >> Aromatic N-hydroxylamines OR SN1 >> Nitrenium Ion
formation >> Aromatic nitro OR SN1 >> Nitrenium Ion formation >>
Aromatic nitroso OR SN1 >> Nitrenium Ion formation >> Aromatic
phenylureas OR SN1 >> Nitrenium Ion formation >> Primary (unsaturated)
heterocyclic amine OR SN1 >> Nitrenium Ion formation >> Primary aromatic
amine OR SN1 >> Nitrenium Ion formation >> Secondary aromatic amine OR
SN1 >> Nitrenium Ion formation >> Tertiary aromatic amine OR SN1 >>
Nitrenium Ion formation >> Unsaturated heterocyclic azo OR SN1 >>
Nitrenium Ion formation >> Unsaturated heterocyclic nitro OR SN2 OR SN2
>> Direct Acting Epoxides and related OR SN2 >> Direct Acting Epoxides
and related >> Aziridines OR SN2 >> Direct Acting Epoxides and related
>> Epoxides OR SN2 >> Episulfonium Ion Formation OR SN2 >> Episulfonium
Ion Formation >> Mustards OR SN2 >> Nitrosation-SN2 OR SN2 >>
Nitrosation-SN2 >> Nitroso-SN2 OR SN2 >> P450 Mediated Epoxidation OR
SN2 >> P450 Mediated Epoxidation >> Thiophenes-SN2 OR SN2 >> SN2 at an
sp3 Carbon atom OR SN2 >> SN2 at an sp3 Carbon atom >> Aliphatic halides
by DNA binding by OECD
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Aryl AND Diketone AND Fused
carbocyclic aromatic AND Fused heterocyclic aromatic AND Indandione AND
Pyridine AND Quinoline/ Isoquinoline by Organic Functional groups
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Fused carbocyclic aromatic AND
Indandione AND Overlapping groups AND Quinoline/ Isoquinoline by Organic
Functional groups (nested)
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Aliphatic Carbon [CH] AND
Aromatic Carbon [C] AND Aromatic Nitrogen AND Carbonyl, aliphatic attach
[-C(=O)-] AND Carbonyl, olefinic attach [-C(=O)-] AND Carbonyl, one
aromatic attach [-C(=O)-] AND Miscellaneous sulfide (=S) or oxide (=O)
AND Olefinic carbon [=CH- or =C<] AND Tertiary Carbon by Organic
functional groups (US EPA)
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Aromatic compound AND Carbonyl
compound AND Ketone by Organic functional groups, Norbert Haider
(checkmol)
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group by Estrogen Receptor Binding
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Moderate binder, NH2 group OR
Moderate binder, OH grooup OR Non binder, impaired OH or NH2 group OR
Non binder, MW>500 OR Non binder, non cyclic structure OR Strong binder,
NH2 group OR Strong binder, OH group OR Weak binder, NH2 group OR Weak
binder, OH group OR Very strong binder, OH group by Estrogen Receptor
Binding
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Aryl AND Diketone AND Fused
carbocyclic aromatic AND Fused heterocyclic aromatic AND Indandione AND
Pyridine AND Quinoline/ Isoquinoline by Organic Functional groups
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as Fused carbocyclic aromatic AND
Indandione AND Overlapping groups AND Quinoline/ Isoquinoline by Organic
Functional groups (nested)
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as Aliphatic Carbon [CH] AND
Aromatic Carbon [C] AND Aromatic Nitrogen AND Carbonyl, aliphatic attach
[-C(=O)-] AND Carbonyl, olefinic attach [-C(=O)-] AND Carbonyl, one
aromatic attach [-C(=O)-] AND Miscellaneous sulfide (=S) or oxide (=O)
AND Olefinic carbon [=CH- or =C<] AND Tertiary Carbon by Organic
functional groups (US EPA)
Domain
logical expression index: "p"
Referential
boundary: The
target chemical should be classified as Aromatic compound AND Carbonyl
compound AND Ketone by Organic functional groups, Norbert Haider
(checkmol)
Domain
logical expression index: "q"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OECD
Domain
logical expression index: "r"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Direct
Acylation Involving a Leaving group OR Acylation >> Direct Acylation
Involving a Leaving group >> Acetates OR Acylation >> Direct Acylation
Involving a Leaving group >> Acyl halides (including benzyl and
carbamoyl deriv.) OR Acylation >> Direct Acylation Involving a Leaving
group >> Anhydrides OR Acylation >> Direct Acylation Involving a Leaving
group >> Azlactone OR Acylation >> Direct Acylation Involving a Leaving
group >> Sulphonyl halides OR Acylation >> Isocyanates and Related
Chemicals OR Acylation >> Isocyanates and Related Chemicals >>
Isothiocyanates OR Acylation >> Ring Opening Acylation OR Acylation >>
Ring Opening Acylation >> alpha-Lactams OR Michael addition OR Michael
addition >> Polarised Alkenes OR Michael addition >> Polarised Alkenes
>> Polarised alkene - amides OR Michael addition >> Polarised Alkenes >>
Polarised alkene - esters OR Michael addition >> Polarised Alkenes >>
Polarised alkene - ketones OR Michael addition >> Quinones and
Quinone-type Chemicals OR Michael addition >> Quinones and Quinone-type
Chemicals >> Pyranones (and related nitrogen chemicals) OR Michael
addition >> Quinones and Quinone-type Chemicals >> Quinone-diimine OR
Michael addition >> Quinones and Quinone-type Chemicals >> Quinone-imine
OR Schiff Base Formers OR Schiff Base Formers >> Direct Acting Schiff
Base Formers OR Schiff Base Formers >> Direct Acting Schiff Base Formers
>> 1-3-Dicarbonyls OR Schiff Base Formers >> Direct Acting Schiff Base
Formers >> Mono-carbonyls OR SN2 OR SN2 >> Episulfonium Ion Formation OR
SN2 >> Episulfonium Ion Formation >> Mustards OR SN2 >> Epoxides and
Related Chemicals OR SN2 >> Epoxides and Related Chemicals >> Epoxides
OR SN2 >> SN2 reaction at a sulphur atom OR SN2 >> SN2 reaction at a
sulphur atom >> Thiols OR SN2 >> SN2 reaction at sp3 carbon atom OR SN2
>> SN2 reaction at sp3 carbon atom >> Alkyl diazo OR SN2 >> SN2 reaction
at sp3 carbon atom >> Alkyl halides OR SN2 >> SN2 reaction at sp3 carbon
atom >> Allyl acetates and related chemicals OR SN2 >> SN2 reaction at
sp3 carbon atom >> alpha-Haloalkenes (and related cyano, sulfate and
sulfonate subs. chem.) OR SN2 >> SN2 reaction at sp3 carbon atom >>
alpha-Halobenzyls (and related cyano, sulfate and sulphonate subs.
chem.) OR SN2 >> SN2 reaction at sp3 carbon atom >> alpha-Halocarbonyls
OR SN2 >> SN2 reaction at sp3 carbon atom >> beta-Halo ethers OR SN2 >>
SN2 reaction at sp3 carbon atom >> Sulfonates OR SNAr OR SNAr >>
Nucleophilic aromatic substitution OR SNAr >> Nucleophilic aromatic
substitution >> Activated halo-benzenes OR SNAr >> Nucleophilic aromatic
substitution >> Halo-triazines by Protein binding by OECD
Domain
logical expression index: "s"
Referential
boundary: The
target chemical should be classified as Not known precedent reproductive
and developmental toxic potential by DART scheme v.1.0
Domain
logical expression index: "t"
Referential
boundary: The
target chemical should be classified as Known precedent reproductive and
developmental toxic potential OR Triazole derivatives (13c) OR Tubolin
interactors.Benzimidazole-like derivatives for metabolites (6b-1) OR
Tubolin interactors.Benzimidazole-like derivatives for metabolites
(6b-1) >> Benzimidazole-like derivatives / Metabolite by DART scheme
v.1.0
Domain
logical expression index: "u"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 1.48
Domain
logical expression index: "v"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 4.31
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- 99.2 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- K2 data from the Qsar Prediction.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The developmental toxicity LOEL (Lowest Observed Effect Level) of D&C Yellow No. 11 in Sprague Dawley rat by the oral route was estimated to be 99.1999 mg/kg bw/day.
Justification for selection of Effect on developmental toxicity: via oral route:
The developmental toxicity LOEL (Lowest Observed Effect Level) of D&C Yellow No. 11 in Sprague Dawley rat by the oral route was estimated to be 99.1999 mg/kg bw/day.
Justification for classification or non-classification
D&C Yellow No. 11 is found to exhibit non toxic reproductive effects at higher doses in a 125 weeks toxicity study in rats. However, the majority use of this chemical is used as a solvent form to color topical drug preparations and cosmetics. Thus, exposure to high levels of direct D&C Yellow No. 11 is likely to be minimal and hence the chemical has not be considered as toxic to reproduction and developmental toxicity for classification.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.