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EC number: 239-888-1 | CAS number: 15790-07-5 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 15985:1.
- 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
Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) .The study assumed the use of male and female Sprague-Dawley rats in subacute study of 28days. No significant alterations were noted at the dose level of 585.3 mg/kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is considered to be 585.3 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- 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:
- Prediction is done using OECD QSAR Toolbox version 3.3 and the supporting QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.3, 2017
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material : aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex
- Molecular formula : C16H9AlN2O7S2
- Molecular weight : 432.368 g/mol
- Smiles notation : c12c(cc(S(=O)(=O)[O-])cc2)ccc(c1\N=N\c1ccc(S(=O)(=O)[O-])cc1)[O-].[Al+3]
- InChl : 1S/C16H12N2O7S2.Al/c19-15-8-1-10-9-13(27(23,24)25)6-7-14(10)16(15)18-17-11-2-4-12(5-3-11)26(20,21)22;/h1-9,19H,(H,20,21,22)(H,23,24,25);/q;+3/p-3/b18-17+;
- Substance type: Organic
- Physical state: Solid - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specified.
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- not specified
- Remarks:
- not specified
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Positive control:
- not specified
- Observations and examinations performed and frequency:
- not specified
- Sacrifice and pathology:
- not specified
- Other examinations:
- not specified
- Statistics:
- not specified
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 585.35 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed at this dose level.
- Remarks on result:
- other: No toxic effect were observed
- Critical effects observed:
- not specified
- Conclusions:
- The predicted No Observed Adverse Effect Level (NOAEL) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) is considered to be 585.3mg/Kg bw/day.
- Executive summary:
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) .The study assumed the use of male and female Sprague-Dawley rats in subacute study of 28days. No significant alterations were noted at the dose level of 585.3 mg/kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is considered to be 585.3 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Reference
The
prediction was based on dataset comprised from the following
descriptors: NOAEL
Estimation method: Takes average value from the 6 nearest neighbours
Domain logical expression:Result: In Domain
((((((((((("a"
or "b" or "c" )
and ("d"
and (
not "e")
)
)
and "f" )
and "g" )
and ("h"
and (
not "i")
)
)
and "j" )
and ("k"
and (
not "l")
)
)
and ("m"
and (
not "n")
)
)
and ("o"
and (
not "p")
)
)
and "q" )
and ("r"
and "s" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Acid moiety OR Not classified OR
Phenols by Aquatic toxicity classification by ECOSAR ONLY
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as Non binder, non cyclic structure
OR Strong binder, OH group by Estrogen Receptor Binding ONLY
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Cation OR Mixture by Substance
Type ONLY
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Not possible to classify
according to these rules by DPRA Cysteine peptide depletion
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as High reactive OR High reactive
>> Activated haloarenes OR High reactive >> alpha,beta-carbonyl
compounds with polarized multiple bonds OR High reactive >>
Diacylperoxides OR High reactive >> Organic disulfides OR High reactive
>> Thiols OR Low reactive OR Low reactive >> Long-chain aliphatic
aldehydes OR Moderate reactive OR Moderate reactive >> Glycidyl ether
epoxides OR Moderate reactive >> Mono-methacrylic acid esters OR
Moderate reactive >> Saturated aldehydes by DPRA Cysteine peptide
depletion
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Not calculated by Hydrolysis
half-life (Ka, pH 7)(Hydrowin) ONLY
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Non binder, non cyclic structure
AND Strong binder, OH group by Estrogen Receptor Binding ONLY
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Not categorized by Repeated dose
(HESS)
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as 3-Methylcholantrene
(Hepatotoxicity) Alert OR Acrylamides (Neurotoxicity) Rank C OR
Aliphatic amines (Mucous membrane irritation) Rank C OR Aliphatic
nitriles (Hepatotoxicity) Rank B OR Aliphatic/Alicyclic hydrocarbons
(Alpha 2u-globulin nephropathy) Rank C OR Allyl esters (Hepatotoxicity)
Rank A OR Carboxylic acids (Hepatotoxicity) No rank OR Ethionine
(Hepatotoxicity) Alert OR Ethyleneglycol alkylethers (Hemolytic anemia)
Rank A OR Halogenated aliphatic compounds (Hepatotoxicity) Rank A OR
Hydrazines (Hemolytic anemia with methemoglobinemia) Rank B OR
Hydrazines (Hepatotoxicity) Rank C OR Methyldopa (Hepatotoxicity) Alert
OR Oximes (Hemolytic anemia with methemoglobinemia) Rank B OR
Oxyphenistain (Hepatotoxicity) Alert OR p-Alkylphenols (Hepatotoxicity)
Rank A OR Perhexiline (Hepatotoxicity) Alert OR Phenols (Mucous membrane
irritation) Rank C OR Tamoxifen (Hepatotoxicity) Alert OR Thioalcohols
(Hepatotoxicity) No rank OR Thiocarbamates/Sulfides (Hepatotoxicity) No
rank OR Valproic acid (Hepatotoxicity) Alert by Repeated dose (HESS)
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Bioavailable by Lipinski Rule
Oasis ONLY
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Inclusion rules not met AND
Phenols by Skin irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as (Hydro)Peroxides OR Acyl halides
OR Aliphatic acids and (Met)acrylic acids OR Aliphatic
alpha-halogen-esters OR Esters including acrylic and methacrylic esters
OR Esters of organic sulfonic or sulfuric esters OR Ethylenglycolethers
OR Ketones OR Quaternary organic ammonium compounds OR Sulfonic acids or
their salts by Skin irritation/corrosion Inclusion rules by BfR
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group All Lipid
Solubility < 0.01 g/kg AND (!Undefined)Group CNS Surface Tension > 62
mN/m AND Exclusion rules not met AND Group All Melting Point > 200 C AND
Group CNS Melting Point > 120 C AND Group CNS Melting Point > 50 C by
Skin irritation/corrosion Exclusion rules by BfR
Domain
logical expression index: "n"
Referential
boundary: The
target chemical should be classified as (!Undefined)Group C Surface
Tension > 62 mN/m OR (!Undefined)Group CN Lipid Solubility < 0.4 g/kg OR
(!Undefined)Group CNHal Lipid Solubility < 4 g/kg OR (!Undefined)Group
CNHal Lipid Solubility < 400 g/kg OR Group All log Kow < -3.1 OR Group C
Melting Point > 55 C OR Group C Vapour Pressure < 0.0001 Pa OR Group
CHal log Kow > 4.5 OR Group CHal Melting Point > 65 C OR Group CHal
Molecular Weight > 280 g/mol OR Group CN Aqueous Solubility < 0.1 g/L OR
Group CN Melting Point > 180 C OR Group CN Molecular Weight > 290 g/mol
OR Group CN Vapour Pressure < 0.001 Pa OR Group CNS log Kow < 0.5 OR
Group CNS log Kow < -2 by Skin irritation/corrosion Exclusion rules by
BfR
Domain
logical expression index: "o"
Referential
boundary: The
target chemical should be classified as No alert found by
Carcinogenicity (genotox and nongenotox) alerts by ISS
Domain
logical expression index: "p"
Referential
boundary: The
target chemical should be classified as Aliphatic halogens (Genotox) OR
Alkyl carbamate and thiocarbamate (Genotox) OR Isocyanate and
isothiocyanate groups (Genotox) OR Metals, oxidative stress (Nongenotox)
OR Structural alert for genotoxic carcinogenicity OR Structural alert
for nongenotoxic carcinogenicity OR Substituted n-alkylcarboxylic acids
(Nongenotox) by Carcinogenicity (genotox and nongenotox) alerts by ISS
Domain
logical expression index: "q"
Similarity
boundary:Target:
[Al]{3+}_Oc1ccc2cc(S(O)(=O)=O)ccc2c1N=Nc1ccc(S(O)(=O)=O)cc1
Threshold=10%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "r"
Parametric
boundary:The
target chemical should have a value of log BCF max which is >= 0.961
log(L/kg wet)
Domain
logical expression index: "s"
Parametric
boundary:The
target chemical should have a value of log BCF max which is <= 1.51
log(L/kg wet)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 585.3 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- K2 OECD QSAR 3.3
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose oral toxicity:
Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5)was assessed for its toxic potential. The target substance is prepared by laking the mother compound disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate Other name; Sunset Yellow (2783-94-0)with Aluminium hydroxide. The experimental study results for read-across substance (CAS: 2783-94-0) are used for toxicity studies . Since the read-across is a major component of the target Aluminium lake substance, the inference can be drawn using the information for the major component. Therefore, it is acceptable to derive information on toxicity from the mother compound. The prediction and experimental studies are as mentioned below for target and mother compound as read across substance.to determine the toxic nature of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5)upon repeated exposure by oral, dermal and inhalation route of exposure. The studies are as mentioned below:
Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) .The study assumed the use of male and female Sprague-Dawley rats in subacute study of 28days. No significant alterations were noted at the dose level of 585.3 mg/kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is considered to be 585.3 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.
Another Repeated dose toxicity study was performed by I. F. GAUNTet al. (Food Cosmetic Toxicol.1974) to determine the oral toxic nature disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate(2783-94-0). In this study male and female mice were given diets containing 0, 250, 500, 1000 and 2000 mg/kg/day of Sunset Yellow FCF for 80 wk. The feeding of Sunset Yellow FCF did not adversely affect the death rate within the groups, the rate of body-weight gain, the organ weights or the haematological findings. The incidence and severity of the histopathological findings were similar in treated and control mice and there was no evidence of an increased incidence of tumours in the mice given Sunset Yellow FCF. It is concluded that in mice Sunset Yellow FCF fed at levels of up to 2000 mg/kg/day in the diet is not carcinogenic and does not exert any long-term toxic effects. Hence 2000 mg/kg/day is assessed to be the NOAEL (No observed adverse effect) value.
In another short-term repeated dose toxicity: oral study was performed by I. F. GAUNT-T et al.( Fd Cosmet. ToxicoL, 1967) for disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate(2783-94-0). Feeding of Sunset Yellow FCF to rats at dietary levels of 0.0 (control), 0.5, 1 .0, 2.0 or 3.0%.for 96 days evoked no adverse effect on growth or food consumption but there was slightdiarrhea throughout the study at 3% and during the first few weeks at 2%. There was nodeparture from normality in the haematological investigations or in the terminal liver an kidney function tests. At autopsy, the caecum was enlarged at the 2 and 3 % levels and the testes at the 3 % level. There were no histological changes attributable to Sunset Yellow FCF. A no-effect level (NOEL) of 1 % Sunset Yellow FCF was established in the diet for 96 days, a level equivalent to 500 mg/kg/day. A low-effect level (LOEL) of 2.0% Sunset Yellow FCF was established in the diet for 96 days, a level equivalent to 1000 mg/kg/day.
Based on the prediction and data available for substance Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) as well as applying weigh of evidence ,does not exhibit toxic nature upon repeated exposure by oral route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Repeated inhalation study:
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex / 15790-07-5, which is reported as 6.88E-018 Pa at 25 deg C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical 1-hydroxybenzotriazole is highly unlikely. Therefore this study is considered for waiver.
Repeated dermal study
The acute toxicity value for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available for the target chemical and its prediction, Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5)does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on theabove annotation for the target chemical . Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) does not exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
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