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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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: Data is from Journal with permission
- Principles of method if other than guideline:
- An irritation profiling was performed to determine thresholds for irritation
- GLP compliance:
- not specified
- Type of study:
- other: Modified Buehler test
- Justification for non-LLNA method:
- not specified
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: No data
- Age at study initiation: No data
- Weight at study initiation: 300-500g
- Housing: 5 per cage
- Diet : ad libitum
- Water: ad libitum
- Acclimation period: No data - Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 95% ethanol
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 95% ethanol
- No. of animals per dose:
- Total animals-13
- Details on study design:
- RANGE FINDING TESTS: No data available
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (Once weekly for 3 consecutive weeks)
- Exposure period: 24hr
- Test groups: 13
- Control group: 13, Concurrent
- Site: Nuchal area
- Frequency of applications: Once weekly
- Duration: 3 consecutive weeks
- Concentrations: 50%
B. CHALLENGE EXPOSURE
- No. of exposures: No data available
- Day(s) of challenge: No data available
- Exposure period: 24hr
- Test groups: 13
- Control group: 13, Concurrent
- Site: No data available
- Concentrations: 1.0, 3.0, 10.0%
- Evaluation (hr after challenge): after 24 hrs rest period
OTHER: One-tailed Mann-Whitney U Statistic (α₌ 0.05) was used to test for statistically significant differences between the scores in the test and vehicle control groups. - Positive control substance(s):
- not specified
- Positive control results:
- All skin responses in control animals were of low order.
- Reading:
- other: Sensitizing
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10.00%
- No. with + reactions:
- 11
- Total no. in group:
- 13
- Clinical observations:
- Mild erythema, usually confluent (barely perceptible)
- Remarks on result:
- other: Reading: other: Sensitizing. . Hours after challenge: 24.0. Group: test group. Dose level: 10.00%. No with. + reactions: 11.0. Total no. in groups: 13.0. Clinical observations: Mild erythema, usually confluent (barely perceptible).
- Interpretation of results:
- other: Weakly Sensitizing
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test compound D &C yellow no. 11 induced delayed type skin sensitization in guinea pig and is found to be a sensitizing to the skin of guinea pigs.
- Executive summary:
Modified Buehler test was performed to study the sensitizing potential ofD &C yellow no. 11 to the skin of Guinea pigs.
The induction phase was accomplished with 24 hr occluded patch in nuchal area once weekly for three consecutive weeks following 2 week resting period. Pigs were initially challenged with dye used during the induction phase and then with the concentration of 1.0, 3.0 and 10%.Thereafter the patches were removed and the guinea pigs were rested for 24 hrs depilated with a chemical depilatory and evaluated and scored for erythema and edema.
D &C yellow no. 11 at a challenge concentration of 10% elicited delayed skin sensitization in 11 of 13 animals and hence is a weak sensitizer. Lower concentrations did not elicit statistically significant response.
According to the publication, the test material is a skin sensitizer.
Reference
Frequency of skin sensitization responses in the guinea pig.
Animals group |
D & C Yellow |
||
1% |
3% |
10% |
|
Test |
4/13 |
6/13 |
11/13 |
Vehicle control |
3/13 |
2/13 |
2/13 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensatization:-
Based on the studies available with Klimish rating 2 for the target substances CAS: 8003-22-3 the results is summarized as follows:
Sr.No
Endpoint
Effect
Species
Sources
1
Skin Sensitisation
Weakly Sensitizing
guinea pig
Data from publication for CAS: 8003-22-3
2
Skin Sensitisation
sensitising
Human
Data from publication for CAS: 8003-22-3
3
Skin Sensitisation
sensitising
Human
Data from publication for CAS: 8003-22-3
By applying weight of evidence approach, it can be concluded that the substance is sensitizing to the skin of guinea pig and human.
Migrated from Short description of key information:
D & C yellow elicit skin sentisitization in 11 of 13 animals at challenge concentration. The study elicit D&C yellow no. 11 induced delayed type skin sensitization in guinea pig was scored as 1 i.e. Mild erythema, usually confluent (barely perceptible) and required a concentration of 10% for elicitation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The chemical D&C Yellow No. 11 is likely to be "sensitizing" to the skin of guinea pig and human as per the available experimental data. Thus, the chemical is classified as being "sensitizing”.
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