Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute toxicity: Oral

The acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolboox version 3.3

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rats was estimated to be 10200 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute oral toxicity to rat.

Acute toxicity: Inhalation

The Vapour pressure of the substance 1,3-isobenzofurandione, reaction products with methylquinoline and quinolone was found to be 2.73X10-9 mm Hg at 25 deg C (Est) which is equivalent to 0.000000363 Pascal. This the exposure by the inhaltion route is unlikely taking into consideration the low values of vapour pressure.

Acute toxicity: Dermal

The acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolboox version 3.3

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rabbits was estimated to be 4586.48 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute oral toxicity to rat.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
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:
not specified
Species:
rat
Strain:
not specified
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data available
No. of animals per sex per dose:
No data available
Control animals:
not specified
Details on study design:
No data available
Statistics:
No data available
Sex:
not specified
Dose descriptor:
LD50
Effect level:
10 200 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality
Mortality:
no mortality
Clinical signs:
other: No data available
Gross pathology:
No data available





The prediction was based on dataset comprised from the following descriptors: LD50
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" and ( not "h") )  )  and "i" )  and ("j" and "k" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Neutral Organics by US-EPA New Chemical Categories

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as SN2 AND SN2 >> Direct acting epoxides formed after metabolic activation AND SN2 >> Direct acting epoxides formed after metabolic activation >> Quinoline Derivatives AND SN2 >> SN2 at an activated carbon atom AND SN2 >> SN2 at an activated carbon atom >> Quinoline Derivatives by DNA binding by OASIS v.1.3

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Non binder, without OH or NH2 group by Estrogen Receptor Binding

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Nucleophilic addition AND Nucleophilic addition >> Addition to carbon-hetero double bonds AND Nucleophilic addition >> Addition to carbon-hetero double bonds >> Ketones AND Schiff base formation AND Schiff base formation >> Direct acting Schiff base formers AND Schiff base formation >> Direct acting Schiff base formers >> 1,2-Dicarbonyls and 1,3-Dicarbonyls  by Protein binding by OASIS v1.3

Domain logical expression index: "e"

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: "f"

Referential boundary: The target chemical should be classified as 1,1-Diaminoalkene derivative [C=C(N)N]  OR 1,2,5-Oxadiazole N-oxide ring  OR 1,2,5-Oxadiazole ring  OR 1,2-Oxaza compounds [N-C-O-] OR 1-Sulfinyl-1-thioalkene derivative [C=C(S)S(=O)]  OR 2,2-bis-(alkoxy)-1-alkanol [COC(C(OH))OC]  OR 2,3,3-Trialkoxy alcohol derivative [HOCC(-O-)C(-O-)(-O-)] OR 2-Alkoxy-2-propenoic acid deriv. [C=C(COOH)-O-C]  OR 2-Aminoalkyl acetamide [NCOCN<] OR 2-Carbonylamino acetate derivative [OC(=O)CNC(=O)] OR 2-Cyano carbonyl compound [C(C#N)CO] OR 2-Hydroxyacetamide derivative [NC(=O)CH2-OH]  OR 2-Oxyalkyl-1,2-ethanediol deriv. [HOCH2CH(OH)CO] OR Acetylenic Carbon [#C] OR Acid, aliphatic attach [-COOH] OR Acid, aromatic attach [-COOH] OR Acyclic carbonyl, two aromatic attach OR Acyl peroxide [C(=O)OOC(=O)-] OR Alcohol, olefinic attach [-OH] OR Alcohol-acid Carbon [HO-C-COOH] OR Aldehyde, aliphatic attach [-CHO] OR Aldehyde, aliphatic attach [-N-CHO] OR Aldehyde, aromatic attach [-CHO] OR Aliphatic 1,2,3-triol [-C(COH)(COH)C-OH] OR Aliphatic Carbon [C] OR Aliphatic Carbon [-CH2-] OR Aliphatic Carbon [-CH3] OR Aliphatic Carbon, two phenyl attach [-C-]  OR Aliphatic Carbon, two phenyl attach [-CH2-]  OR Aliphatic Nitrogen, one aromatic attach [-N] OR Aliphatic Nitrogen, two aromatic attach [-N-] OR Aliphatic Oxygen, not {v+2} OR Aliphatic Oxygen, two aromatic attach [-O-] OR Aliphatic Suflur, one aromatic attach [-S-] OR Aliphatic Sulfur, two aromatic attach OR Aliphatic-C=N-Aliphatic  OR Alkenyl sufide [-S=C] OR Alkyl sulfinylalkyl sulfide [CSCS(=O)] OR Alpha Amino acid OR Alpha,beta-unsaturated carbonyl compound [C=C(N)C(=O)] OR Alpha-cyano beta-carbonyl comp.[=C-(C#N)-CO-] OR Alpha-cyano-alpha,beta-unsat. carboxylates OR Alpha-dicarbonyl compound [-C(=O)-] OR Alpha-diether [C-O-C-O-C] OR Alpha-diketone, aromatic attach [-CO-CO-] OR Alpha-diketone, olefinic attach [-CO-CO-] OR Alpha-dithioether [C-S-C-S-C] OR Alpha-hydrazino-alpha,beta-unsat. carbonyl comp. [-C=C(NN)C(=O)] OR Alpha-oxoamide [C(C(=O))C(=O)N] OR Amide, aliphatic attach [-C(=O)N] OR Amide, aromatic attach [-C(=O)N] OR Amidine, aromatic attach [C(-NH)N] OR Amino acid, non-alpha carbon type  OR Amino diol derivative [OCC(N)CO] OR Amino Triazine/Pyrazine/Pyrimidine  OR Amino urea  OR Amino, aliphatic attach [-N<] OR Amino, aliphatic attach [-NH-] OR Amino, aliphatic attach [-NH2] OR Amino-carbonyl compound [NCC(=O)-C] OR Amino-ethylcyano [-N-CH-C#N]  OR Aromatic Nitrogen, [N{v+5}] OR Aromatic Nitrogen, five-member ring OR Aromatic Oxygen OR Aromatic Sulfur OR Aromatic-N-C-Aromatic  OR Azo [-N=N-] OR Azomethine, aliphatic attach [-N=C] OR Benzene to CCN  OR Beta-cyanamide [C(C#N)C(=O)N] OR Beta-dicarbonyl compound [C-CO-C-CO-C] OR Beta-hydroxy-carbonyl compound [CC(=O)C-OH] OR Beta-oxyalkyl ester [-OCC(-O-)C(=O)] OR Biguanide, aliphatic attach  OR Biguanide, aromatic attach  OR Bismuth [Bi] OR Boron [B] OR Bromine, aliphatic attach [-Br] OR Bromine, aromatic attach [-Br] OR Bromine, olefinic attach [-Br] OR Calcium [Ca] OR Carbamate [-OC(=O)N] OR Carbonate, aliphatic attach [-OC(=O)O-] OR Carbonate, aromatic attach [-OC(=O)O-] OR Carbonyl, non-cyclic, two aromatic attach [-C(=O)-] OR Chlorine, aliphatic attach [-Cl] OR Chlorine, aromatic attach [-Cl] OR Chlorine, olefinic attach [-Cl] OR -CO-N-CO five member ring (not pyrroledione) OR Cyano, aliphatic attach [-C#N] OR Cyano, aromatic attach [-C#N] OR Cyano, -C=N attach [C#N-C=N] OR Cyano, nitrogen attach [-C#N] OR Cyclic dithiocarbamate [-NC(=S)S-] OR Cyclic ester OR Cyclic ester [-C(=O)O-C{-N or O}]  OR Cyclic esters, olefinic type  OR Diarylketone OR Diazonium [N#N or =N{+}=N{-}] OR Dihydroxy-aceton derivative [HOCC(=O)CO-] OR Dihydroxy-aceton derivative [HOCC(=O)COH] OR Dihydroxycarbonyl compound [HO-CC(OH)C(=O)-] OR Diketone, olefinic carbon  OR Disulfide [-SS-] OR Dithiocarbamate, linear [NC(=S)S] OR Diureide [C(=ONC(=O)NC(=O)] OR Ester, aliphatic attach [-C(=O)O] OR Ester, aromatic attach [-C(=O)O] OR Ether-alcohols [-OC(COH)CO-] OR Fluorine, aliphatic attach [-F] OR Fluorine, aromatic attach [-F] OR Fluorine, olefinic attach [-F] OR Fused Aliphatic ring unit  OR Geminal dinitroamine [NO2-NCN-NO2] OR Geminal-N-thioalkyl alkanol [CN=CNC] OR Glycerols [HOCHC(OH)CHOH] OR Halogen, nitrogen attach OR Halogen, sulfinyl attach OR Hydrazine [>N-N<] OR Hydrazo compound [-NH-NH-] OR Hydroxy, aliphatic attach [-OH] OR Hydroxy, aromatic attach [-OH] OR Hydroxy, nitrogen attach [-OH] OR Hydroxy, oxygen attach [-OH] OR Hydroxy, phosphorus attach [-OH] OR Hydroxy, sulfur attach [-OH] OR Imine, linear [-CH=NC-]  OR Iodide, aliphatic attach [-I] OR Iodide, aromatic attach [-I] OR Iron [Fe] OR Isocyanate, aliphatic attach [-N=C=O] OR Isocyanate, aromatic attach [-N=C=O] OR Ketimine (cyclic, aromatic attach) OR Ketimine, aromatic attach [>C=NH]  OR Ketone in a ring, olefinic aromatic attach OR Miscellaneous metal [Ni, Cu, Zr, Be] OR Monohalo acetamide OR Multi alcohol  OR N-Aminoalkyl thioacylamide or S-aminoalkyl dithioacetamide OR N-aminomethylene subst. aromatic amine [>NC=N-ar] OR N-aryl arene amide[C{ar}NC(=O)C{ar}] OR Nitrate, aliphatic attach [-ONO2] OR Nitro, aromatic attach [-NO2] OR Nitro, nitrogen attach [-NO2] OR Nitrogen {v+5}, nitrogen attach OR Nitrogen oxide, aromatic nitrogen [n=O] OR Nitrogen oxide, aromatic nitrogen [n=O] non fused  OR Nitrogen, hydrogen attach {v+5} OR Nitrogen, phosphorus attach [-N-P] OR Nitrogen, single bonds  [N{v+5}] OR Nitrogen, two or tree olefinic attach [>N-] OR No functional group found OR N-oxoalkyl-2-aminocarboxylic acid [CC(=O)NCCOOH] OR N-oxoalkyl-2-thioalkyl-2-aminocarboxylic acid OR N-Substituted 1,2,3-Triazole OR Olefinic carbon [=CH2] OR Ortho-alkoxy/thio, to one aromatic N OR Ortho-amino pyridine  OR Ortho-hydroxy to misc. -CO-  OR Ortho-substitutes on N=C<, aromatic OR Oxazole ring (non fused)  OR Oxycarbonyl compound [CCCOC-O-] OR Oxycarbonyl compound [-OCCOC-O] OR Oxygen or Sulfur, nitrogen attach [-O- or -S-] OR Oxygen, [#O] OR Oxygen, aliphatic attach [-O-] OR Oxygen, nitrogen attach [-O-] OR Oxygen, one aromatic attach [-O-] OR Oxygen, oxygen attach [-O-] OR Oxygen, two olefinic attach [-O-] OR Oxygen, two phosphorus attach [P-O-P] OR Phosphine oxide [O=P] OR Phosphine Type [>P-] OR Phosphite, aliphatic attach [-O-P] OR Phosphite, aromatic attach [-O-P] OR Phosphorus, halogen attach [P] OR Phosphorus, single bonds  [P] OR Poly alcohol Carbon [HO-C-OH]  OR Polyfluoroalkyl thio or alcohol/ether OR Pyridine Ester, 2-position  OR Pyridine, non fused rings  OR Pyrrole-2,5-dione  OR Semicarbazone [C=NN-CO-N-]  OR Silicon, aliphatic attach [-Si-] OR Silicon, aromatic or oxygen attach [-Si-] OR Substituted Carbon on [-SO-N=C-N-]  OR Suflur {v+4} or {v+6} OR Suflur, di- or poly suflur attach [S] OR Sulfamide, aromatic attach [-SO2-N] OR Sulfate, linear [-O-SO2-O-] OR Sulfinic acid [-S(=O)OH] OR Sulfite, linear [-OS(=O)O-] OR Sulfonate, aromatic attach [-SO2-O] OR Sulfone, aliphatic attach [-SO2-] OR Sulfone, aromatic attach [-SO2] OR Sulfone, nitrogen and oxygen attach [-O-SO2-N] OR Sulfone, two aromatic attach [-SO2-] OR Sulfonyl amide, aromatic attach [-S(=O)N-] OR Sulfoxide, aliphatic attach [-S(=O)-] OR Sulfoxide, aromatic attach [-S(=O)-] OR Sulfoxide, nitrogen and oxygen attach [-S(=O)-] OR Sulfoxide, two aromatic attach [-S(=O)-] OR Sulful halide [-S-] OR Sulfur, aliphatic attach [-S-] OR Sulfur, nitrogen attach [-S-] OR Sulfur, phosphorus attach [-S-] OR Sulphonate, aliphatic attach [-SO2-O] OR Sym-Triazine ring  OR Tetrahydrazo-1,3-diazine deriv.  [SCC(-N-)COH] OR Thiocarbonyl, olefinic attach [-C(=S)-] OR Thiol, aliphatic attach [-SH] OR Thio-phosphorus [S=P] OR Thiourea [-NC(=S)N-] OR Thioureido-pyrmidine [-N-CO-NS] OR Tiadiazine type [-SO-N=C-N-]  OR Tin [Sn] OR Tin, oxigen attach [Sn] OR Triazene [-N=N-N-] OR Unsaturated gama-dicarbonyl comp. [-C(=O)C=CC(=O)-] OR Urea [-OC(=O)N-] OR Urea, N and N'-diaryl subsrituted  OR Ureide [NC(=O)NC(=O)] OR Zinc [Zn] by Organic functional groups (US EPA)

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as No alert found by Protein binding by OECD

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as Michael addition OR Michael addition >> Polarised Alkenes OR Michael addition >> Polarised Alkenes >> Polarised alkene - aldehydes OR Schiff Base Formers OR Schiff Base Formers >> Direct Acting Schiff Base Formers OR Schiff Base Formers >> Direct Acting Schiff Base Formers >> Mono-carbonyls by Protein binding by OECD

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Bioavailable by Lipinski Rule Oasis ONLY

Domain logical expression index: "j"

Parametric boundary:The target chemical should have a value of log Kow which is >= 3.17

Domain logical expression index: "k"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.35

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rats was estimated to be 10200 mg/kg bw.
Executive summary:

The acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolboox version 3.3

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rats was estimated to be 10200 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute oral toxicity to rat.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
10 200 mg/kg bw
Quality of whole database:
Weight of evidence has been considered from various sources that indicate the chemical D&C Yellow No. 11 do not have acute oral toxicity as per the CLP regulation

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
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:
not specified
Test type:
other: estimation
Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
No data
Doses:
No data
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
No data
Statistics:
No data
Sex:
not specified
Dose descriptor:
LD50
Effect level:
4 586.48 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality
Mortality:
No mortality
Clinical signs:
other: No data available
Gross pathology:
No data available
Other findings:
No data available





The prediction was based on dataset comprised from the following descriptors: LD50
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" )  and ("h" and "i" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Neutral Organics by US-EPA New Chemical Categories

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as SN2 AND SN2 >> Direct acting epoxides formed after metabolic activation AND SN2 >> Direct acting epoxides formed after metabolic activation >> Quinoline Derivatives AND SN2 >> SN2 at an activated carbon atom AND SN2 >> SN2 at an activated carbon atom >> Quinoline Derivatives by DNA binding by OASIS v.1.3

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Non binder, without OH or NH2 group by Estrogen Receptor Binding

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Nucleophilic addition AND Nucleophilic addition >> Addition to carbon-hetero double bonds AND Nucleophilic addition >> Addition to carbon-hetero double bonds >> Ketones AND Schiff base formation AND Schiff base formation >> Direct acting Schiff base formers AND Schiff base formation >> Direct acting Schiff base formers >> 1,2-Dicarbonyls and 1,3-Dicarbonyls  by Protein binding by OASIS v1.3

Domain logical expression index: "e"

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: "f"

Referential boundary: The target chemical should be classified as 1,2-Oxaza compounds [N-C-O-] OR 2-Aminoalkyl acetamide [NCOCN<] OR 2-Cyano carbonyl compound [C(C#N)CO] OR 2-Oxyalkyl-1,2-ethanediol deriv. [HOCH2CH(OH)CO] OR Acetylenic Carbon [#C] OR Acid, aliphatic attach [-COOH] OR Acid, aromatic attach [-COOH] OR Alcohol, olefinic attach [-OH] OR Alcohol-acid Carbon [HO-C-COOH] OR Aldehyde, aliphatic attach [-CHO] OR Aldehyde, aliphatic attach [-N-CHO] OR Aldehyde, aromatic attach [-CHO] OR Aliphatic 1,2,3-triol [-C(COH)(COH)C-OH] OR Aliphatic Carbon [C] OR Aliphatic Carbon [-CH2-] OR Aliphatic Carbon [-CH3] OR Aliphatic Carbon, two phenyl attach [-C-]  OR Aliphatic Carbon, two phenyl attach [-CH2-]  OR Aliphatic Nitrogen, one aromatic attach [-N] OR Aliphatic Nitrogen, two aromatic attach [-N-] OR Aliphatic Oxygen, not {v+2} OR Aliphatic Suflur, one aromatic attach [-S-] OR Alkenyl sufide [-S=C] OR Alpha-cyano beta-carbonyl comp.[=C-(C#N)-CO-] OR Alpha-cyano-alpha,beta-unsat. carboxylates OR Alpha-diether [C-O-C-O-C] OR Alpha-oxoamide [C(C(=O))C(=O)N] OR Amide, aliphatic attach [-C(=O)N] OR Amide, aromatic attach [-C(=O)N] OR Amino diol derivative [OCC(N)CO] OR Amino, aliphatic attach [-N<] OR Amino, aliphatic attach [-NH-] OR Amino, aliphatic attach [-NH2] OR Amino-carbonyl compound [NCC(=O)-C] OR Aromatic Nitrogen, five-member ring OR Aromatic Sulfur OR Azo [-N=N-] OR Azomethine, aliphatic attach [-N=C] OR Beta-dicarbonyl compound [C-CO-C-CO-C] OR Beta-oxyalkyl ester [-OCC(-O-)C(=O)] OR Biguanide, aliphatic attach  OR Biguanide, aromatic attach  OR Bromine, aliphatic attach [-Br] OR Bromine, aromatic attach [-Br] OR Bromine, olefinic attach [-Br] OR Carbonate, aliphatic attach [-OC(=O)O-] OR Chlorine, aliphatic attach [-Cl] OR Chlorine, aromatic attach [-Cl] OR Chlorine, olefinic attach [-Cl] OR Cyano, aliphatic attach [-C#N] OR Cyano, aromatic attach [-C#N] OR Cyclic dithiocarbamate [-NC(=S)S-] OR Cyclic ester OR Cyclic esters, olefinic type  OR Diarylketone OR Dihydroxycarbonyl compound [HO-CC(OH)C(=O)-] OR Diureide [C(=ONC(=O)NC(=O)] OR Ester, aliphatic attach [-C(=O)O] OR Ether-alcohols [-OC(COH)CO-] OR Fluorine, aliphatic attach [-F] OR Fluorine, aromatic attach [-F] OR Fluorine, olefinic attach [-F] OR Fused Aliphatic ring unit  OR Geminal dinitroamine [NO2-NCN-NO2] OR Geminal-N-thioalkyl alkanol [CN=CNC] OR Glycerols [HOCHC(OH)CHOH] OR Hydrazine [>N-N<] OR Hydroxy, aliphatic attach [-OH] OR Hydroxy, aromatic attach [-OH] OR Hydroxy, sulfur attach [-OH] OR Isocyanate, aliphatic attach [-N=C=O] OR Isocyanate, aromatic attach [-N=C=O] OR Ketone in a ring, olefinic aromatic attach OR Miscellaneous metal [Ni, Cu, Zr, Be] OR Multi alcohol  OR Nitrate, aliphatic attach [-ONO2] OR Nitro, aromatic attach [-NO2] OR Nitro, nitrogen attach [-NO2] OR Nitrogen {v+5}, nitrogen attach OR Nitrogen oxide, aromatic nitrogen [n=O] OR Nitrogen oxide, aromatic nitrogen [n=O] non fused  OR Nitrogen, single bonds  [N{v+5}] OR Nitrogen, two or tree olefinic attach [>N-] OR No functional group found OR Olefinic carbon [=CH2] OR Ortho-substitutes on N=C<, aromatic OR Oxygen or Sulfur, nitrogen attach [-O- or -S-] OR Oxygen, [#O] OR Oxygen, aliphatic attach [-O-] OR Oxygen, nitrogen attach [-O-] OR Oxygen, one aromatic attach [-O-] OR Oxygen, oxygen attach [-O-] OR Oxygen, two olefinic attach [-O-] OR Phosphine oxide [O=P] OR Phosphine Type [>P-] OR Phosphite, aliphatic attach [-O-P] OR Phosphite, aromatic attach [-O-P] OR Phosphorus, halogen attach [P] OR Phosphorus, single bonds  [P] OR Pyridine, non fused rings  OR Silicon, aromatic or oxygen attach [-Si-] OR Suflur {v+4} or {v+6} OR Sulfinic acid [-S(=O)OH] OR Sulfite, linear [-OS(=O)O-] OR Sulfonate, aromatic attach [-SO2-O] OR Sulfur, nitrogen attach [-S-] OR Sulphonate, aliphatic attach [-SO2-O] OR Sym-Triazine ring  OR Thiocarbonyl, olefinic attach [-C(=S)-] OR Thiol, aliphatic attach [-SH] OR Triazene [-N=N-N-] OR Urea [-OC(=O)N-] OR Urea, N and N'-diaryl subsrituted  OR Ureide [NC(=O)NC(=O)] OR Zinc [Zn] by Organic functional groups (US EPA)

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Bioavailable by Lipinski Rule Oasis ONLY

Domain logical expression index: "h"

Parametric boundary:The target chemical should have a value of log Kow which is >= 3.17

Domain logical expression index: "i"

Parametric boundary:The target chemical should have a value of log Kow which is <= 4.35

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rabbits was estimated to be 4586.48 mg/kg bw.
Executive summary:

The acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolboox version 3.3

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rabbits was estimated to be 4586.48 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute dermal toxicity to rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
4 586.48 mg/kg bw
Quality of whole database:
The acute dermal median lethal dose (LD50) of the test material, D&C Yellow No. 11 in rabbits was estimated to be 4586.48 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute dermal toxicity to rabbits.

Additional information

Acute toxicity: Oral

The acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolbox version 3.3

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rats was estimated to be 10200 mg/kg bw. Also, the study report indicates the median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rats was found to be >5000mg/kg.

Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute oral toxicity to rat.

 

Acute toxicity: Inhalation

The Vapour pressure of the substance 1,3-isobenzofurandione, reaction products with methylquinoline and quinolone was found to be 2.73X10-9 mm Hg at 25 deg C (Est) which is equivalent to 0.000000363 Pascal. This the exposure by the inhaltion route is unlikely taking into consideration the low values of vapour pressure.

 

Acute toxicity: Dermal

The acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolbox version 3.3

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rabbits was estimated to be 4586.48 mg/kg bw. Also, the study report indicates the median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rabbits was found to be >2000mg/kg.

Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute oral toxicity to rat.

Justification for selection of acute toxicity – oral endpoint

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11  in rats was estimated to be 1955.80 mg/kg bw.

Justification for selection of acute toxicity – inhalation endpoint

The Vapour pressure of the substance 1,3-isobenzofurandione, reaction products with methylquinoline and quinolone was found to be 2.73X10-9 mm Hg at 25 deg C (Est) which is equivalent to 0.000000363 Pascal. This the exposure by the inhaltion route is unlikely taking into consideration the low values of vapour pressure.

Justification for selection of acute toxicity – dermal endpoint

The median lethal dose (LD50) value of the test substance D&C Yellow No. 11  in rabbits was estimated to be 4586.48 mg/kg bw.

Justification for classification or non-classification

The available information indicates that the substance D&C Yellow No. 11 (CAS No 8003-22-3) is not likely to exhibit acute toxicity by the oral, inhalation & dermal route of exposure and hence is not classified as causing Acute Oral, Inhalation and Dermal toxicity according to CLP regulation.