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EC number: 274-426-2 | CAS number: 70210-30-9
- 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
Repeated dose toxicity: Oral:
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 toxicity was predicted for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4-sulphonatophenyl)azo] benzenesulphonate]. The study assumed the use of male and female rats in a 28 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4- sulphonatophenyl)azo] benzenesulphonate] is predicted to be 568.900024414 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:
- Data is from OECD QSAR Toolbox version 3.4 and the supporting QMRF report has been attached
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Prediction is done using OECD QSAR Toolbox version 3.4, 2018
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- - Name of test material: Tetrasodium 2,2'-[1,4-phenylenebis[carbonylimino[2-acetamido-4,1-phenylene]azo]]bis[5-[(4-sulphonatophenyl)azo] benzenesulphonate]
- IUPAC name: tetrasodium 2-[(E)-2-{2-acetamido-4-[4-({3-acetamido-4-[(E)-2-{2-sulfonato-4-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl} diazen-1-yl]phenyl}carbamoyl)benzamido]phenyl}diazen-1-yl]-5-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]benzene-1-sulfonate
- Molecular formula: C48H34N12Na4O16S4
- Molecular weight: 1255.09 g/mole
- Smiles : [Na+].[Na+].[Na+].[Na+].c1(ccc(cc1)C(=O)Nc1cc(c(cc1)\N=N\c1c(cc(cc1)\N=N\c1ccc(cc1)S(=O)(=O)[O-])S(=O)(=O)[O-])NC(=O)C)C (=O)Nc1cc(c(cc1)\N=N\c1c(cc(cc1)\N=N\c1ccc(cc1)S(=O)(=O)[O-])S(=O)(=O)[O-])NC(=O)C
- Inchl: 1S/C48H38N12O16S4.4Na/c1-27(61)49-43-23-33(11-19-39(43)57-59-41-21-13-35(25-45(41)79(71,72)73)55-53-31-7-15-37(16-8-31) 77(65,66)67)51-47(63)29-3-5-30(6-4-29)48(64)52-34-12-20-40(44(24-34)50-28(2)62)58-60-42-22-14-36(26-46(42)80(74,75)76)56-54-32-9-17-38(18-10-32)78(68,69)70;;;;/h3-26H,1-2H3,(H,49,61)(H,50,62)(H,51,63)(H,52,64)(H,65,66,67)(H,68,69,70)(H,71,72,73)(H,74,75,76);;;;/q;4*+1/p-4/b55-53+,56-54+,59-57+,60-58+;;;;
- Substance type: Organic
- Physical state: Solid - Species:
- rat
- Strain:
- CD-1
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Details on route of administration:
- No data
- Vehicle:
- not specified
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 3 months
- Frequency of treatment:
- Daily
- Remarks:
- No data
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- No data
- Other examinations:
- No data
- Statistics:
- No data
- 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
- Details on results:
- No data
- Dose descriptor:
- NOAEL
- Effect level:
- 568.9 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effects were noted at the mentioned dose level
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4- sulphonatophenyl)azo] benzenesulphonate] is predicted to be 568.900024414 mg/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 toxicity was predicted for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4-sulphonatophenyl)azo] benzenesulphonate]. The study assumed the use of male and female rats in a 28 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4- sulphonatophenyl)azo] benzenesulphonate] is predicted to be 568.900024414 mg/Kg bw/day.
Based on this value it can be concluded that the substance is considered to be 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 5 nearest neighbours
Domain logical expression:Result: In Domain
(((((((((("a"
or "b" or "c" or "d" or "e" )
and ("f"
and (
not "g")
)
)
and ("h"
and (
not "i")
)
)
and ("j"
and (
not "k")
)
)
and ("l"
and (
not "m")
)
)
and "n" )
and "o" )
and "p" )
and ("q"
and (
not "r")
)
)
and ("s"
and "t" )
)
Domain
logical expression index: "a"
Referential
boundary: The
target chemical should be classified as Non-covalent interaction AND
Non-covalent interaction >> DNA intercalation AND Non-covalent
interaction >> DNA intercalation >> DNA Intercalators with Carboxamide
and Aminoalkylamine Side Chain by DNA binding by OASIS v.1.4
Domain
logical expression index: "b"
Referential
boundary: The
target chemical should be classified as SN1 AND SN1 >> Nitrenium Ion
formation AND SN1 >> Nitrenium Ion formation >> Aromatic azo by DNA
binding by OECD
Domain
logical expression index: "c"
Referential
boundary: The
target chemical should be classified as Acylation AND Acylation >>
Acylation involving an activated (glucuronidated) carboxamide group AND
Acylation >> Acylation involving an activated (glucuronidated)
carboxamide group >> Carboxylic Acid Amides AND Acylation >> Direct
acylation involving a leaving group AND Acylation >> Direct acylation
involving a leaving group >> Carboxylic Acid Amides AND Acylation >>
Ester aminolysis AND Acylation >> Ester aminolysis >> Amides AND AN2 AND
AN2 >> Michael-type addition to quinoid structures AND AN2 >>
Michael-type addition to quinoid structures >> Carboxylic Acid Amides
by Protein binding by OASIS v1.4
Domain
logical expression index: "d"
Referential
boundary: The
target chemical should be classified as Acylation AND Acylation >>
Direct Acylation Involving a Leaving group AND Acylation >> Direct
Acylation Involving a Leaving group >> Acetates by Protein binding by
OECD
Domain
logical expression index: "e"
Referential
boundary: The
target chemical should be classified as Acid moiety AND Amides AND Salt
by Aquatic toxicity classification by ECOSAR
Domain
logical expression index: "f"
Referential
boundary: The
target chemical should be classified as Non binder, MW>500 by Estrogen
Receptor Binding
Domain
logical expression index: "g"
Referential
boundary: The
target chemical should be classified as Moderate binder, NH2 group OR
Non binder, impaired OH or NH2 group by Estrogen Receptor Binding
Domain
logical expression index: "h"
Referential
boundary: The
target chemical should be classified as Non binder, MW>500 by Estrogen
Receptor Binding
Domain
logical expression index: "i"
Referential
boundary: The
target chemical should be classified as Non binder, without OH or NH2
group by Estrogen Receptor Binding
Domain
logical expression index: "j"
Referential
boundary: The
target chemical should be classified as Non binder, MW>500 by Estrogen
Receptor Binding
Domain
logical expression index: "k"
Referential
boundary: The
target chemical should be classified as Strong binder, OH group by
Estrogen Receptor Binding
Domain
logical expression index: "l"
Referential
boundary: The
target chemical should be classified as Not categorized by Repeated dose
(HESS)
Domain
logical expression index: "m"
Referential
boundary: The
target chemical should be classified as Thiocarbamates/Sulfides
(Hepatotoxicity) No rank OR Valproic acid (Hepatotoxicity) Alert by
Repeated dose (HESS)
Domain
logical expression index: "n"
Similarity
boundary:Target:
CC(=O)Nc1cc(NC(=O)c2ccc(C(=O)Nc3ccc(N=Nc4ccc(N=Nc5ccc(S(=O)(=O)O{-}.[Na]{+})cc5)cc4S(=O)(=O)O{-}.[Na]{+})c(NC(C)=O)c3)cc2)ccc1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1S(=O)(=O)O{-}.[Na]{+}
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "o"
Similarity
boundary:Target:
CC(=O)Nc1cc(NC(=O)c2ccc(C(=O)Nc3ccc(N=Nc4ccc(N=Nc5ccc(S(=O)(=O)O{-}.[Na]{+})cc5)cc4S(=O)(=O)O{-}.[Na]{+})c(NC(C)=O)c3)cc2)ccc1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1S(=O)(=O)O{-}.[Na]{+}
Threshold=30%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "p"
Similarity
boundary:Target:
CC(=O)Nc1cc(NC(=O)c2ccc(C(=O)Nc3ccc(N=Nc4ccc(N=Nc5ccc(S(=O)(=O)O{-}.[Na]{+})cc5)cc4S(=O)(=O)O{-}.[Na]{+})c(NC(C)=O)c3)cc2)ccc1N=Nc1ccc(N=Nc2ccc(S(=O)(=O)O{-}.[Na]{+})cc2)cc1S(=O)(=O)O{-}.[Na]{+}
Threshold=40%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization
Domain
logical expression index: "q"
Referential
boundary: The
target chemical should be classified as Anion AND Aromatic compound AND
Azo compound AND Carbonic acid derivative AND Carboxylic acid derivative
AND Carboxylic acid sec. amide AND Cation AND Sulfonic acid derivative
by Organic functional groups, Norbert Haider (checkmol)
Domain
logical expression index: "r"
Referential
boundary: The
target chemical should be classified as Aryl chloride by Organic
functional groups, Norbert Haider (checkmol)
Domain
logical expression index: "s"
Parametric
boundary:The
target chemical should have a value of log Kow which is >= 0.36
Domain
logical expression index: "t"
Parametric
boundary:The
target chemical should have a value of log Kow which is <= 10
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 568.9 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from K2 QSAR prediction database
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
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 toxicity: Oral:
Prediction model based estmation for the target chemical and data from read across chemicals has been reviewed to determine the toxic nature of the test chemical Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex. The studies are as summarized 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 toxicity was predicted for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4-sulphonatophenyl)azo] benzenesulphonate]. The study assumed the use of male and female rats in a 28 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4- sulphonatophenyl)azo] benzenesulphonate] is predicted to be 568.900024414 mg/Kg bw/day.
The experimental data for the read across chemicals is as mentioned below:
Repeated dose toxicity test were performed by Drake et al (Food and Cosmetic Toxicology, 1977) on mice with different concentrations from 0.1, 0.25, 0.5 or 1.0% (130, 325, 650, 1300 mg/kg bw/d) 60 -70% structurally and functionally similar read across chemical Black PN (RA CAS no 2519 -30 -4; IUPAC name: Tetra sodium 1-acetamido-2-hydroxy-3- (4-((4-sulphonato phenylazo) -7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate) for 80 wk. 30 males and 30 females was used for the treatment and group of 60 mice of each sex as control. During the study period the animals were observed for clinical signs, mortality, hematology, urine analysis was performed and the animals were subjected to gross and histopathology. The general condition and behaviour of the animals were observed frequently and any mouse that showed signs of ill-health was isolated, to be returned to its cage on recovery or to be killed if its condition deteriorated. The mice were weighed at the start of the experiment, at wk 3 and then at intervals of 2 wk until wk 73 of the experiment. Blood sample were taken at wk 28 and 55. At 80 wk, blood samples were collected from the aorta of all surviving mice during the autopsy. For haematology blood samples were collected and for urine sample from 6-hr period from three groups of five mice of each sex from the controls and the groups on the two highest dietary levels of Black PN. Histopathology was also conducted. The ingestion of Black PN had no effect on the condition or behaviour and mortality of the animals. The haematological examinations revealed only inconsistent isolated changes of statistical significance. At wk 28 the haemoglobin concentrations and red blood cell counts were lower in female mice fed diet containing if 0.5 or 1.0% Black PN than in the controls. There were no comparable findings in the males. The total white cell count of the male animals fed 1.0% Black PN in the diet was higher than that of the controls at this time, but there was no comparable change in this measurement in the females, or in either sex at any other time. At wk 55, the haemoglobin concentrations of male animals fed 0.5% of the coiouring in the diet were significantly (P < 0.05) lower than the control values. However, the corresponding value at the higher dietary level was not affected and there were no differences from the control value in the females. Also at wk 55, the erythrocyte counts of females fed 1.0% Black PN were lower (P < 0.01) than those of the controls, but this finding was again isolated. There were no statistically significant differences between the control and test samples taken at wk 80. There were only scattered differences in mean organ weights between treated and control animals. A lower brain weight in females, compared with the control value, was the only difference affecting animals fed 1% Black PN. This difference, which did not occur in the males, was only marginally significant and there was no significant difference when the weights were expressed relative to body weight By contrast, the relative brain weight of females fed 0.25% Black PN was higher than the control figure. Liver weights of female but not of male mice fed 0.25% Black PN were lower than control values, but again this was an isolated finding and there were no significant differences in relative liver weights. Kidney weights of male animals only were significantly lower than control values at the two lowest levels of treatment (0.1 and 0.25%), but a significant difference in relative kidney weights of males occurred only at the 0.5% level, at which a higher value was recorded for the treated mice. The only other significant differences occurred in the relative heart weights, which were raised in male mice fed 0.5% and in females fed 0.25% Black PN. The incidence of histological findings was similar in all groups of mice, including the controls. Most of the tumours in the study occurred with either a comparable or a greater incidence in the control groups than in the treated mice. Several isolated tumours were identified in mice given the lower levels of Black PN, without comparable findings in the controls or in the highest dose group. They were a mammary fibroadenoma (in a female on 0.1%), a uterine fibromyoma (0.19%) and a squamous-cell carcinoma of the skin (female, 0.5%). The only tumour found at the highest dietary level without comparable control findings was a squamous- cell carcinoma of the skin in a male mouse fed 1% Black PN. Based on these considerations, the no observed adverse effect level (NOAEL) for Black PN in mice is considered to be 1 % (1300 mg/kg/day).
In another study by Gaunt et al (Food and Cosmetic Toxicology, 1972) for the same read across chemical, repeated dose oral toxicity test was performed on the male and female rats at different concentrations 0, 1000, 5000 or 10,000 ppm (0, 50, 250 or 500 mg/Kg/day) for 2 yrs to determine the toxic nature of 60 -70% structurally and functionally similar read across chemical Brilliant Black 1 (RA CAS no 2519 -30 -4; IUPAC name: Tetra sodium 1-acetamido-2-hydroxy-3- (4-((4-sulphonato phenylazo) -7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate). The rats were obtained from SPF colony and Spillers' Laboratory Small Animal Diet and water availablead lib. Animals were maintained at controlled temperature and humidity atmosphere. Groups of 24 male (body weight 115-140 g) and 24 female (body weight 115-130 g) rats housed four to a cage were fed on diets Black PN for up to 2 yr. Body-weight gain, food intake, haematology, serum chemistry, renal concentration tests, organ weights or incidence of pathological findings, including tumours were performed. Some effects were observed but no effects attributable to treatment. The fur and faeces of the rats fed diets containing Black PN were coloured black. Mortality : Many rats died or were killed during the course of the study but at no time were the numbers of deaths in the Black PN-treated animals significantly greater than those of the controls. The majority of the deaths occurred in the last 6 months of treatment. There were no significant differences between treated and control rats in body-weight gain and food consumption. No effects was observed in the mean daily intakes of Black PN were approximately 40, 180 and 360 mg/kg/day in males and 45, 240 and 470 mg/kg/day in females at the three dietary levels. No adverse haematological changes were seen in either sex or at any dietary level up to 12 months. At wk 82, the haemoglobin concentration and packed cell volume were reduced in females fed a diet containing 10,000 ppm Black PN. These effects were not found after 2 yr, although at this time this group showed a reduction in the total leucocyte count. There was no black colour in urine collected free of faecal or other contamination. There were no statistically significant differences between the absolute organ weights of control rats and those of rats fed diets containing Black PN .However, in male rats, the relative liver weights were significantly higher in all treated groups than in the controls. Chronic rat nephropathy was found in many of the animals. This consisted of renal tubular dilation, protein casts and foci of round-cell infiltration. Chronic lung changes encountered consisted of peribronchial and perivascular lymphocyte cuffing. The incidence of these findings did not vary significantly between treated and control groups. Based on the observations made, the No observed adverse effect level (NOAEL) for Brilliant Black 1 is considered to be 500 mg/Kg/day when exposed by oral route of exposure to male and female rats for 2 years.
Gaunt et al (Food and Cosmetic Toxicology, 1974) performed repeated oral toxicity of another functionally similar read across chemical Sunset Yellow FCF (RA CAS no 2783 -94 -0; IUPAC name: disodium 6-hydroxy-5-[(4-sulfonatophenyl)diazenyl]naphthalene-2-sulfonate) by performing a 80 weeks repeated dose toxicity study using Charles River CD mouse (male and female) at dose levels of 0, 100, 200, 400 or 800 mg/Kg (0.2, 0.4, 0.8 or 1.6% respectively) by oral diet route. The animals were observed for clinical signs, mortality, body weight changes, hematology and were subjected to gross and histopathology. 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. Distension of the bladder, frequently associated with hydroureter and hydronephosis was noted. Pus and hard protein deposits were found in the bladders of many of the mice and in a number of cases it was possible to show that an obstruction had occurred in the urethra in the region of the bulbo-urethral complex. After the male mice were put into individual cages, there was a marked reduction in the number showing this syndrome, although isolated cases of urinary retention were seen throughout the study. Of the malignant tumours found, lymphomas and reticulum-cell neoplasms occurred in treated and control mice. In addition a splenic haemangiosarcoma and a mammary carcinoma were found in the female mice fed on the diet containing the lowest level of Sunset Yellow FCF (100 mg/Kg). A single tumour of the Harderian gland was found in a female from the group given the 1.6% level. The commonest benign tumours were pulmonary adenomas and benign cysts in the ovary, found with a similar frequency in treated and control mice. The only other tumour occurring in treated mice without a similar finding in the controls was a granulosa-cell tumour of the ovary in a mouse given 800 mg/Kg Sunset Yellow FCF. Thus, on the basis of above results the NOAEL (no observed adverse effect level) for Sunset Yellow FCF was considered to be 800 mg/kg diet.
Based on the available data for the functionally similar read across chemicals and the applying the weight of evidence approach, Benzenesulfonic acid, 2,2'-(1,4-phenylenebis(carbonylimino (2-(acetylamino)-4,1-phenylene)-2,1- diazenediyl))bis(5-(2-(4-sulfophenyl)diazenyl)-, sodium salt (1:4) is considered to be not likely to classify as a toxicant upon repeated exposure by oral route.
Justification for classification or non-classification
Based on the available data for the functionally similar read across chemicals and the applying the weight of evidence approach, Benzenesulfonic acid, 2,2'-(1,4-phenylenebis(carbonylimino (2-(acetylamino)-4,1-phenylene)-2,1- diazenediyl))bis(5-(2-(4-sulfophenyl)diazenyl)-, sodium salt (1:4) (CAS no 70210 -30 -9) is considered to be not likely to classify as a toxicant upon repeated exposure by oral route
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