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EC number: 235-473-4 | CAS number: 12239-15-5
- 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
Skin Irritation:
The dermal irritation potential of Acid Yellow 49 was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor.
Acid Yellow 49 was estimated to be not irritating to the skin of New Zealand White rabbits.
Based on the estimated result; Acid Yellow 49 can be considered not irritating to skin and can be classified under the category “Not classified” as per CLP regulation.
Eye Irritation:
The ocular irritation potential of Acid Yellow 49 was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor.
Acid Yellow 49 was estimated to be irritating to the eyes of New Zealand White rabbits.
Based on the estimated results, Acid Yellow 49 can be considered irritating to eyes and can be classified under the category “Category 2” as per CLP regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- data is from OECD QSAR toolbox v3.3 and the QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: Estimated data
- Principles of method if other than guideline:
- Prediction was done using OECD QSAR toolbox v3.3
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material: 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid
- Common Name: Acid Yellow 49
- IUPAC name: 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid
- Molecular formula: C16H13Cl2N5O3S
- Molecular weight: 426.283 g/mole
- Smiles :n1(c2ccccc2)c(c(\N=N\c2c(cc(S(O)(=O)=O)c(c2)Cl)Cl)c(n1)C)N
- InChl: 1S/C16H13Cl2N5O3S/c1-9-15(16(19)23(22-9)10-5-3-2-4-6-10)21-20-13-7-12(18)14(8-11(13)17)27(24,25)26/h2-8H,19H2,1H3,(H,24,25,26)/b21-20+
- Substance type: Organic
- Physical state: Solid powder (yellow) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 0.8 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- no data available
- Other effects / acceptance of results:
- no data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of irritation observed
- Interpretation of results:
- other: not irritating
- Conclusions:
Acid Yellow 49 was estimated to be not irritating to the skin of New Zealand White rabbits.- Executive summary:
The dermal irritation potential of Acid Yellow 49 was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor.
Acid Yellow 49 was estimated to be not irritating to the skin of New Zealand White rabbits.
Based on the estimated result; Acid Yellow 49 can be considered not irritating to skin and can be classified under the category “Not classified” as per CLP regulation.
Reference
Estimation
method: Takes mode value from the 7 nearest neighbours
Domain logical expression:Result: In Domain
(((("a"
or "b" or "c" )
and ("d"
and (
not "e")
)
)
and "f" )
and ("g"
and "h" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Acid moiety OR Anilines
(Unhindered) OR Pyrazoles/Pyrroles by Aquatic toxicity classification by
ECOSAR ONLY
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as SNAr OR SNAr >> Nucleophilic
aromatic substitution OR SNAr >> Nucleophilic aromatic substitution >>
Activated halo-benzenes by Protein binding by OECD ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as SN1 OR SN1 >> Nitrenium Ion
formation OR SN1 >> Nitrenium Ion formation >> Primary (unsaturated)
heterocyclic amine OR SN1 >> Nitrenium Ion formation >> Unsaturated
heterocyclic azo by DNA binding by OECD ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Radical OR Radical >> Radical
mechanism by ROS formation OR Radical >> Radical mechanism by ROS
formation >> Polynitroarenes OR Radical >> Radical mechanism via ROS
formation (indirect) OR Radical >> Radical mechanism via ROS formation
(indirect) >> Nitroaniline Derivatives OR Radical >> Radical mechanism
via ROS formation (indirect) >> Nitroarenes with Other Active Groups OR
Radical >> Radical mechanism via ROS formation (indirect) >>
Nitrophenols, Nitrophenyl Ethers and Nitrobenzoic Acids OR Radical >>
Radical mechanism via ROS formation (indirect) >> Single-Ring
Substituted Primary Aromatic Amines OR SN1 OR SN1 >> Carbenium ion
formation OR SN1 >> Carbenium ion formation >> Alpha-Haloethers OR SN1
>> Nucleophilic attack after diazonium or carbenium ion formation OR SN1
>> Nucleophilic attack after diazonium or carbenium ion formation >>
Nitroarenes with Other Active Groups OR SN1 >> Nucleophilic attack after
metabolic nitrenium ion formation OR SN1 >> Nucleophilic attack after
metabolic nitrenium ion formation >> Single-Ring Substituted Primary
Aromatic Amines OR SN1 >> Nucleophilic attack after reduction and
nitrenium ion formation OR SN1 >> Nucleophilic attack after reduction
and nitrenium ion formation >> Nitroaniline Derivatives OR SN1 >>
Nucleophilic attack after reduction and nitrenium ion formation >>
Nitroarenes with Other Active Groups OR SN1 >> Nucleophilic attack after
reduction and nitrenium ion formation >> Nitrophenols, Nitrophenyl
Ethers and Nitrobenzoic Acids OR SN1 >> Nucleophilic attack after
reduction and nitrenium ion formation >> Polynitroarenes OR SN2 OR SN2
>> SN2 at sp3-carbon atom OR SN2 >> SN2 at sp3-carbon atom >>
Alpha-Haloethers OR SN2 >> SN2 attack on activated carbon Csp3 or Csp2
OR SN2 >> SN2 attack on activated carbon Csp3 or Csp2 >> Nitroarenes
with Other Active Groups by DNA binding by OASIS v.1.3
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion
formation AND SN1 >> Nitrenium Ion formation >> Primary (unsaturated)
heterocyclic amine AND SN1 >> Nitrenium Ion formation >> Unsaturated
heterocyclic azo by DNA binding by OECD ONLY
Domain
logical expression index: "g"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= -0.536
Domain
logical expression index: "h"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 5.24
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:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
- Justification for type of information:
- data is from OECD QSAR toolbox v3.3 and the QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: Estimated data
- Principles of method if other than guideline:
- Prediction was done using OECD QSAR toolbox v3.3
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material: 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid
- Common Name: Acid Yellow 49
- IUPAC name: 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid
- Molecular formula: C16H13Cl2N5O3S
- Molecular weight: 426.283 g/mole
- Smiles :n1(c2ccccc2)c(c(\N=N\c2c(cc(S(O)(=O)=O)c(c2)Cl)Cl)c(n1)C)N
- InChl: 1S/C16H13Cl2N5O3S/c1-9-15(16(19)23(22-9)10-5-3-2-4-6-10)21-20-13-7-12(18)14(8-11(13)17)27(24,25)26/h2-8H,19H2,1H3,(H,24,25,26)/b21-20+
- Substance type: Organic
- Physical state: Solid powder (yellow) - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- no data available
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- no data available
- Other effects / acceptance of results:
- no data available
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- signs of irritation observed
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Acid Yellow 49 was estimated to be irritating to the eyes of New Zealand White rabbits
- Executive summary:
The ocular irritation potential of Acid Yellow 49 was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor.
Acid Yellow 49 was estimated to be irritating to the eyes of New Zealand White rabbits.
Based on the estimated results, Acid Yellow 49 can be considered irritating to eyes and can be classified under the category “Category 2” as per CLP regulation.
Reference
Estimation
method: Takes mode value from the 8 nearest neighbours
Domain logical expression:Result: In Domain
((((((((((((((("a"
or "b" or "c" )
and ("d"
and (
not "e")
)
)
and ("f"
and (
not "g")
)
)
and "h" )
and ("i"
and (
not "j")
)
)
and "k" )
and ("l"
and (
not "m")
)
)
and ("n"
and (
not "o")
)
)
and ("p"
and (
not "q")
)
)
and ("r"
and (
not "s")
)
)
and ("t"
and (
not "u")
)
)
and ("v"
and (
not "w")
)
)
and "x" )
and ("y"
and (
not "z")
)
)
and ("aa"
and "ab" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Acid moiety OR Anilines
(Unhindered) OR Pyrazoles/Pyrroles by Aquatic toxicity classification by
ECOSAR ONLY
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as SNAr OR SNAr >> Nucleophilic
aromatic substitution OR SNAr >> Nucleophilic aromatic substitution >>
Activated halo-benzenes by Protein binding by OECD ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as SN1 OR SN1 >> Nitrenium Ion
formation OR SN1 >> Nitrenium Ion formation >> Primary (unsaturated)
heterocyclic amine OR SN1 >> Nitrenium Ion formation >> Unsaturated
heterocyclic azo by DNA binding by OECD ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as No alert found by DNA binding by
OASIS v.1.3
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Radical OR Radical >> Radical
mechanism by ROS formation OR Radical >> Radical mechanism by ROS
formation >> Polynitroarenes OR Radical >> Radical mechanism via ROS
formation (indirect) OR Radical >> Radical mechanism via ROS formation
(indirect) >> Nitroaniline Derivatives OR Radical >> Radical mechanism
via ROS formation (indirect) >> Nitroarenes with Other Active Groups OR
Radical >> Radical mechanism via ROS formation (indirect) >>
Nitrophenols, Nitrophenyl Ethers and Nitrobenzoic Acids OR Radical >>
Radical mechanism via ROS formation (indirect) >> Single-Ring
Substituted Primary Aromatic Amines OR SN1 OR SN1 >> Carbenium ion
formation OR SN1 >> Carbenium ion formation >> Alpha-Haloethers OR SN1
>> Nucleophilic attack after diazonium or carbenium ion formation OR SN1
>> Nucleophilic attack after diazonium or carbenium ion formation >>
Nitroarenes with Other Active Groups OR SN1 >> Nucleophilic attack after
metabolic nitrenium ion formation OR SN1 >> Nucleophilic attack after
metabolic nitrenium ion formation >> Single-Ring Substituted Primary
Aromatic Amines OR SN1 >> Nucleophilic attack after reduction and
nitrenium ion formation OR SN1 >> Nucleophilic attack after reduction
and nitrenium ion formation >> Nitroaniline Derivatives OR SN1 >>
Nucleophilic attack after reduction and nitrenium ion formation >>
Nitroarenes with Other Active Groups OR SN1 >> Nucleophilic attack after
reduction and nitrenium ion formation >> Nitrophenols, Nitrophenyl
Ethers and Nitrobenzoic Acids OR SN1 >> Nucleophilic attack after
reduction and nitrenium ion formation >> Polynitroarenes OR SN2 OR SN2
>> SN2 at sp3-carbon atom OR SN2 >> SN2 at sp3-carbon atom >>
Alpha-Haloethers OR SN2 >> SN2 attack on activated carbon Csp3 or Csp2
OR SN2 >> SN2 attack on activated carbon Csp3 or Csp2 >> Nitroarenes
with Other Active Groups by DNA binding by OASIS v.1.3
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding by OASIS v1.3
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Acylation OR Acylation >> Ester
aminolysis OR Acylation >> Ester aminolysis >> Amides OR SNAr OR SNAr >>
Nucleophilic aromatic substitution on activated aryl and heteroaryl
compounds OR SNAr >> Nucleophilic aromatic substitution on activated
aryl and heteroaryl compounds >> Activated aryl and heteroaryl compounds
by Protein binding by OASIS v1.3
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as No superfragment by
Superfragments ONLY
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as No alert found by Protein
binding alerts for Chromosomal aberration by OASIS v1.1
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as AN2 OR AN2 >> Michael addition
to the quinoid type structures OR AN2 >> Michael addition to the quinoid
type structures >> N-Subsituted Aromatic Amines OR AN2 >> Michael
addition to the quinoid type structures >> Substituted Anilines by
Protein binding alerts for Chromosomal aberration by OASIS v1.1
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis ONLY
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Aromatic diazo AND Hydrazine AND
Primary aromatic amine,hydroxyl amine and its derived esters by in vitro
mutagenicity (Ames test) alerts by ISS
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Aliphatic halogens OR No alert
found by in vitro mutagenicity (Ames test) alerts by ISS
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as Aromatic diazo AND
H-acceptor-path3-H-acceptor AND Hydrazine AND Primary aromatic amine,
hydroxyl amine and its derived esters by in vivo mutagenicity
(Micronucleus) alerts by ISS
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as 1-phenoxy-benzene by in vivo
mutagenicity (Micronucleus) alerts by ISS
Domain
logical expression index: "p"
Referential
boundary: The
target chemical should be classified as Aromatic Amine Type Compounds by
Oncologic Primary Classification
Domain
logical expression index: "q"
Referential
boundary: The
target chemical should be classified as Acrylate Reactive Functional
Groups by Oncologic Primary Classification
Domain
logical expression index: "r"
Referential
boundary: The
target chemical should be classified as Not categorized by Repeated dose
(HESS)
Domain
logical expression index: "s"
Referential
boundary: The
target chemical should be classified as Pirprofen (Hepatotoxicity) Alert
by Repeated dose (HESS)
Domain
logical expression index: "t"
Referential
boundary: The
target chemical should be classified as Not categorized by Repeated dose
(HESS)
Domain
logical expression index: "u"
Referential
boundary: The
target chemical should be classified as Chlorphentermine
(Hepatotoxicity) Alert by Repeated dose (HESS)
Domain
logical expression index: "v"
Referential
boundary: The
target chemical should be classified as Not categorized by Repeated dose
(HESS)
Domain
logical expression index: "w"
Referential
boundary: The
target chemical should be classified as 3-Methylcholantrene
(Hepatotoxicity) Alert OR Aliphatic amines (Mucous membrane irritation)
Rank C by Repeated dose (HESS)
Domain
logical expression index: "x"
Similarity
boundary:Target:
CC1C(N=Nc2cc(Cl)c(S(O)(=O)=O)cc2Cl)=C(N)N(c2ccccc2)N=1
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "y"
Referential
boundary: The
target chemical should be classified as 1,1-Diaminoalkene derivative
[C=C(N)N] AND Aliphatic Carbon [CH] AND Aliphatic Carbon [-CH2-] AND
Aliphatic Carbon [-CH3] AND Aliphatic Nitrogen, one aromatic attach [-N]
AND Aromatic Carbon [C] AND Aromatic Nitrogen, five-member ring AND Azo
[-N=N-] AND Azomethine, aliphatic attach [-N=C] AND Chlorine, aromatic
attach [-Cl] AND Chlorine, olefinic attach [-Cl] AND Hydrazine [>N-N<]
AND Hydroxy, sulfur attach [-OH] AND Miscellaneous sulfide (=S) or oxide
(=O) AND Nitrogen, two or tree olefinic attach [>N-] AND Olefinic carbon
[=CH- or =C<] AND Suflur {v+4} or {v+6} AND Sulfinic acid [-S(=O)OH] AND
Sulfonate, aromatic attach [-SO2-O] by Organic functional groups (US EPA)
Domain
logical expression index: "z"
Referential
boundary: The
target chemical should be classified as 1,2-Oxaza compounds [N-C-O-] by
Organic functional groups (US EPA)
Domain
logical expression index: "aa"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 0.887
Domain
logical expression index: "ab"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 3.56
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Various studies have been evaluated to assess the degree of dermal irritation caused by Acid Yellow 49 in living organisms. The studies are based on in vivo experiments along with predicted data for target chemical and its structurally similar read across substances, Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzenesulphonate(Acid Yellow 11)[CAS: 6359-82-6] and Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate](D&C Red 9)[CAS:5160-02-1]. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
In a prediction done by SSS (2017) using the OECD QSAR toolbox v3.3 with log kow as the primary descriptor, the skin irritation potential was estimated for Acid Yellow 49. It was estimated that Acid Yellow 49 was not irritating to skin of New Zealand White rabbits.
Skin irritation effects were also estimated by four different models i.e, Battery, Leadscope, SciQSAR and CASE Ultra used within Danish QSAR database for Acid Yellow 49. Based on estimation, no severe skin irritation effects were known when Acid Yellow 49 was exposed to rabbit skin. Hence, Acid Yellow 49 can be considered not irritating to skin.
Both the estimated data are in mutual agreement with each other indicating a strong possibility of Acid Yellow 49 being not irritating to skin.
The above results are supported by the experimental study performed by JAMES E. FULTON, JR(J. Soc. Cosmet. Chem., 40, 321-333 (November/December 1989)) to indicate the Comedogenicity and irritancy of thestructurally similar read across substance,Barium bis[2 -chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate](D&C Red 9)[CAS:5160-02-1]. D&C Red 9 was mixed in propylene glycol at a 9 to 1 dilution for testing unless otherwise indicated (10% concentration). A colony of New Zealand albino rabbits that have genetically good ears and free from mites were used. Three rabbits, weighing two to three kilograms, were used for each assay. Animals were housed singly in suspended cages and fed Purina Rabbit Chow and water ad libitum. Animals were maintained on a 12-hour light and 12-hour dark cycle. A dose of 1 ml of the test material was applied and spread once daily to the entire inner surface of once for five days per week for two weeks. The opposite untreated ear of each animal served as an untreated control.The irritancy produced by repeated application of the chemical on the surface epidermis in the rabbit ear is evaluated on a scale of 0 to 5. The grades are summarized as follows:
0 = No irritation; 1 = few scales, no Erythema; 2 = diffuse scaling, no Erythema; 3 = Generalized scaling with Erythema; 4 = Scaling, Erythema and Edema; 5 = Epidermal necrosis and slough.
D&C Red 9 falls under Grade 0 (no irritation observed).Hence it can be concluded that D&C Red 9 was not irritating to rabbit ears.
These results are further supported by the experimental study summarized in Environment and Quality of Life - Reports (Seventh Series), Acid yellow 11, European Commission (EC) - Scientific Committee on Cosmetology (SCC);for thestructurally similar read across substance, Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzenesulphonate(Acid Yellow 11)[CAS: 6359-82-6]. 100mg undiluted suspension of the test substance was applied to intact or abraded rabbit skin and observed for signs of irritation (duration not mentioned). No skin reactions were observed. Hence, Sodium 4-(3-hydroxy-5-methyl-4-phenylazopyrazol-2-yl)benzene sulphonate was considered to be not irritating to rabbits.
Based on the available data for the target as well as it read across substances;and applying the weight of evidence approach, it can be concluded thatAcid Yellow 49 was not irritating to
skin.Comparing the above annotations with the criteria of CLP regulation,Acid Yellow 49 can be classified under the category “Not Classified”.
Eye Irritation:
Various studies have been evaluated to assess the degree of ocular irritation caused by Acid Yellow 49 in living organisms. The studies are based on in vivo experiments along with predicted data for target chemical and its structurally similar read across substance, 2,5-dichloro-4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid[CAS: 84-57-1]. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.
The ocular irritation potential of Acid Yellow 49 was estimated using OECD QSAR toolbox version 3.3 with logPow as the primary descriptor. Acid Yellow 49 was estimated to be irritating to the eyes of New Zealand White rabbits. Based on the estimated results, Acid Yellow 49 can be considered irritating to eyes and can be classified under the category “Category 2” as per CLP regulation.
This is supported by the experimental study summarized in RTECS - DR6040000, Registry of Toxic Effects of Chemical Substances (RTECS), last updated 1997; for the structurally similar read across substance, 2,5-dichloro-4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid[CAS: 84-57-1]. 500 mg of the test chemical was instilled into the eyes of rabbits and effects were observed for 24 hours. Mild irritation effects were observed in rabbit eyes after 24 hours of exposure to 2,5-dichloro-4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1 -yl)benzene-1-sulfonic acid. Hence, 2,5-dichloro-4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid can be considered to be irritating to eyes.
Based on the available data for the target as well as it read across substances;and applying the weight of evidence approach, it can be concluded that Acid Yellow 49 was irritating to eyes.Comparing the above annotations with the criteria of CLP regulation,Acid Yellow 49 can be classified under the category “Category 2”.
Justification for classification or non-classification
Available data for Acid Yellow 49 indicates that it is not likely to cause any irritation or corrosion to skin, but may cause irritation to eyes.
Hence, Acid Yellow 49 can be classified under the category “Not Classified” for skin irritation and “Category 2” for eye irritation as per CLP regulation.
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