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EC number: 220-491-7 | CAS number: 2783-94-0
- 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
The substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be not irritating in skin and eye category.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Principles of method if other than guideline:
- The skin irritation study was conducted to evaluate the irritating effects of administration of sunset yellow FCF to rabbits.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- other: petrolatum or water
- Controls:
- not specified
- Duration of treatment / exposure:
- no data
- Observation period:
- no data
- Number of animals:
- no data
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- no data
- Remarks on result:
- other: not irritating
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin.
- Executive summary:
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Principles of method if other than guideline:
- The eye irritation study was conducted to evaluate the irritating effects of administration of sunset yellow FCF to eye of rabbits.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- not specified
- Controls:
- not specified
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Reversibility:
- not specified
- Remarks on result:
- other: minimally irritant to the rabbit eye
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.
- Executive summary:
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
Weight of evidence studies were reviewed for skin irritation from reliable sources having Klimish rating 2 and 4.
The summary of the results are presented below
Sr.No |
Irritation Parameter |
Species |
Interpretation of results |
Conclusions |
Sources |
1. |
overall irritation score |
Rabbit |
Not irritating |
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin. |
Experimental data from ‘BIBRA report’ for target CAS:2783-94-0 |
2. |
overall irritation score |
Rabbit |
Not irritating |
Test material produced very slight redness of abraded skin in some of the rabbits when observed at only 24 hours after application. The overall result concluded that this was a false positive reaction. Under the conditions in this experiment the material Acid Orange 7 is classified as non-irritant to the skin. |
Experimental data from ‘Journal of Pharmacology and Experimental Therapeutics’ for read across CAS:633-96-5 |
3. |
overall irritation score |
Rabbit |
Not irritating |
The test substance disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate (ALLURA RED AC) did not produce any skin irritation effect on rabbit skin. |
Experimental data from study report of ‘Joint FAO/WHO Expert Committee on Food Additives’ for read across CAS:25956-17-6 |
Based on the above experimental data, it is concluded that the substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate (sunset yellow FCF)was found to be not irritating to the skin of rabbit.
Eye irritation:
Weight of evidence studies were reviewed for eye irritation from reliable sources having Klimish rating 2 and 4.
The summary of the results are presented below
Sr.No |
Irritation Parameter |
Species |
Interpretation of results |
Conclusions |
Sources |
1. |
overall irritation score |
Rabbit |
Not irritating |
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit. |
Experimental data from ‘BIBRA report’ for target CAS:2783-94-0 |
2. |
MMAS(modified maximum average score (MMAS)) |
Rabbit |
Not irritating |
The modified maximum average score (MMAS) from QSAR toolbox eye irritation score of Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate is estimated as 18. This score indicates that test substance is not irritating to the eye of rabbit.(as the criteria MMAS ≤ 25 is not irritating). |
Predicted data from QSAR for target CAS:2783-94-0 |
3. |
overall irritation score |
Rabbit |
Not irritating |
During experimental study 100 mg of test compound (Acid Orange 7)was administered to eye of 3 male rabbits no sign of irritation was observed during experiment thus it is concluded that Acid Orange 7 dose not classify as eye irritant. |
Experimental data from publication for read across CAS: 633-96-5 |
Based on the above experimental data, it is concluded that the substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate (sunset yellow FCF)was found to be not irritating to the eye of rabbit.
Justification for selection of skin irritation / corrosion endpoint:
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF)in petrolatum or in aqueous solutions was found to be not irritating to rabbit skin.
Justification for selection of eye irritation endpoint:
Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate (sunset yellow FCF) was found to be minimally irritant to the rabbit eye which is not enough to classify as eye irritant thus test substance was considered to be non irritant to eye of rabbit.
Justification for classification or non-classification
The available studies indicate that the substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl) azo] naphthalene-2-sulphonate (sunset yellow FCF) is not classified as a skin and eye irritant according to CLP regulation.
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