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EC number: 209-608-2 | CAS number: 587-98-4
- 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
The No Observed Adverse Effect
level (NOAEL) for the test compound sodium
3-[(4-anilinophenyl)diazenyl]benzenesulfonate (metanil yellow) is
determined to be 500 mg/Kg bw upon repeated exposure for 180 days to
male and female albino mice by oral intubation route.
Repeated dose toxicity: inhalation
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 sodium
3-[(4-anilinophenyl)diazenyl]benzenesulfonate, which is reported as
6.93E-16 Pa. Thus, exposure to inhalable dust, mist and vapour of the
chemical sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate is highly
unlikely. Therefore this study is considered for waiver.
Repeated dose toxicity: dermal
The acute toxicity value for
sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (as provided in
section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that
sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate shall not exhibit
28 day repeated dose toxicity by the dermal route. In addition, there is
no dermal absorption data as well as no data available that suggests
that sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate shall exhibit
repeated dose toxicity by the dermal route. Hence this end point was
considered for waiver.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Chronic oral toxicity study was performed to determine the oral toxic nature of metanil yellow upon repeated exposure
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: Ext. D&C Yellow No. 1
- IUPAC name: sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate
- Molecular formula: C18H15N3O3SNa
- Molecular weight: 375.383 g/mol
- Substance type: organic
- Physical state: No data
- Purity: No data available
- Impurities (identity and concentrations): no data available - Species:
- mouse
- Strain:
- other: Albino
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 20-25 g
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): pelleted lab chow (Hindustan Lever Ltd., Bombay, India)
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24°C ±1°C
- Humidity (%):No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: To: No data - Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: Feed
- Remarks:
- pelleted lab chow (Hindustan Lever Ltd., Bombay, India)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Metanil yellow was mixed with pelleted lab chow (Hindustan Lever Ltd., Bombay, India) at dose levels of 0, 100, 500 or 3000 mg/Kg bw
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): pelleted lab chow (Hindustan Lever Ltd., Bombay, India)
- Concentration in vehicle: 0, 100, 500 or 3000 mg/Kg bw
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 180 days
- Frequency of treatment:
- Daily
- Remarks:
- 0, 100, 500 or 3000 mg/Kg bw
- No. of animals per sex per dose:
- Total: 320
0 mg/Kg bw: 40 males and 40 females
100 mg/Kg bw: 40 males and 40 females
500 mg/Kg bw: 40 males and 40 females
3000 mg/Kg bw: 40 males and 40 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Throughout the experiment
- Cage side observations checked in table [No.?] were included. General condition of the animals was observed
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: No data
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: After 180 days
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Total erythrocyte count (TEC), Differential leukocyte count (DLC)- neutrophils, lymphocytes, monocytes, eosinophils, basophils, hemoglobin, erythrocyte sedimentation rate (ESR), mean corpuscular volume (MCV), MCG, MCHC, Heinz bodies, platelet count (PC), PCV, Bleeding time (BT), coagulation time (CT)
CLINICAL CHEMISTRY: No data
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, organs were removed for gross pathology
HISTOPATHOLOGY: No data - Other examinations:
- No data
- Statistics:
- No detailed data available
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- General condition was unaffected at dose levels of 100 and 500 mg/Kg bw except at 3000 mgKg bw
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- 100 mg/Kg bw: No abnormalilties were observed
500 mg/Kg bw: No abnormalilties were observed
3000 mg/Kg bw: Statistical analysis of various values exhibited significant decrease in TEC and Hb and increase in ESR, MCV and MCH suggesting normochromic macrocytic anaemia.
TLC, PC, PCV, MCHC, BT and CT, however, remained normal in both male and female animals.
A marked increase in the number of lymphocytes and macrocytes and a decrease in the number of neutrophils and eosinophils suggesting the occurrence of chronic lymphocytic leukaemia.
Heinz bodies began to appear in the blood after 3 months feeding in mice fed metanil yellow at 3.0 g/kg body weight and were observed in 80-90% erythrocytes at the end of the experiment.
Blood showed marked anisocytosis, poikilocytosis, stomatocytes, schistocytes and a large number of target cells, all normochromic in character. An
overwhelming preponderance of mature lymphocytes with scant cytoplasm, larger and denser clumps of nuclear chromatin and accentuation of parachromatin were also observed, which were suggestive of chronic lymphocytic leukaemia. - 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Mice fed metanil yellow at 3000 mg/kg bw showed hepatomegaly and splenomegaly at autopsy.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Clinical signs and mortality
Clinical signs: General condition was unaffected at dose levels of 100 and 500 mg/Kg bw except at 3000 mgKg bw
Mortality: No data
Body weight and weight gain: No data
Food consumption and compound intake: No data
Food efficiency: No data
Water consumption and compound intake: No data
Opthalmoscopic examination: No data
Haematology:
100 mg/Kg bw: No abnormalilties were observed
500 mg/Kg bw: No abnormalilties were observed
3000 mg/Kg bw: Statistical analysis of various values exhibited significant decrease in TEC and Hb and increase in ESR, MCV and MCH suggesting normochromic macrocytic anaemia.
TLC, PC, PCV, MCHC, BT and CT, however, remained normal in both male and female animals.
A marked increase in the number of
lymphocytes and macrocytes and a decrease in the number of neutrophils and eosinophils suggesting the occurrence of chronic lymphocytic leukaemia.
Heinz bodies began to appear in the blood after 3 months feeding in mice fed metanil yellow at 3.0 g/kg body weight and were observed in 80-90% erythrocytes at the end of the experiment.
Blood showed marked anisocytosis, poikilocytosis, stomatocytes, schistocytes and a large number of target cells, all normochromic in character. An
overwhelming preponderance of mature lymphocytes with scant cytoplasm, larger and denser clumps of nuclear chromatin and accentuation of parachromatin were also observed, which were suggestive of chronic lymphocytic leukaemia.
Clinical chemistry: No data
Urinanalysis: No data
Neurobehaviour: No data
Organ weights: No data
Gross pathology: Mice fed metanil yellow at 3000 mg/kg bw showed hepatomegaly and splenomegaly at autopsy.
Histopathology: No data - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- gross pathology
- haematology
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed Adverse Effect level (NOAEL) for the test compound sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (metanil yellow) is determined to be 500 mg/Kg bw upon repeated exposure for 180 days to male and female albino mice by oral intubation route.
- Executive summary:
Chronic oral toxicity study was performed to determine the oral toxic nature of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (metanil yellow) upon repeated exposure for 180 days. The test compound was force fed to male and female albino mice by oral intubation at a dose levels of 0, 100, 500 or 3000 mg/Kg bw.
The animals were observed for general condition, changes in hematological parameters and gross pathology.
General condition was unaffected at dose levels of 100 and 500 mg/Kg bw except at 3000 mgKg bw. No change was observed by the 100 and 500 mg/Kg bw but feeding of this colour at the rate of 3000 mg/kg body weight led to certain changes in the haematological values. Total erythrocyte count (TEC) and Hb had decreased whereas ESR, MCV, and mean corpuscular haemoglobin (MCH) had increased. These facts suggested the occurrence of normochromic macrocytic anaemia. Differential leukocyte count (DLC) showed marked increase in the number of lymphocytes and monocytes and decrease in the number of neutrophils and eosinophils. Heinz bodies were observed in 80-90% erythrocytes. Other haematological values like total leukocyte count (TLC), platelet count (PC), PCV, MCHC, bleeding time (BT) and coagulation time (CT) were normal at 3000 mg/Kg bw.
Hence, the No Observed Adverse Effect level (NOAEL) for the test compound metanil yellow is 500 mg/Kg bw.
Reference
Table I Haematological Findings in Male Mice Fed with Metanil Yellow at 0.0 and 3.0 G/Kg Body Weight Concentrations
No. |
Experiment |
SI Unit |
0 mg/Kg bw |
3000 mg/Kg bw |
1 |
Total erythrocyte count (TEC) |
1012/L |
6.13±0.45 |
3.86 ± 0.70 |
2 |
Differential leukocyte count (DLC) Neutrophils Lymphocytes Monocytes Eosinophils Basophils |
109/L |
5.67 ± 0.23 3.28 ± 0.16 0.44 ± 0.02 0.05 ± 0.01 0.00 ± 0.00 |
0.44 ± 0.16 9.10±0.44 0.65±0.03 0.01 ± 0.00 0.01 ± 0.00 |
3 |
Haemoglobin (Hb) |
g/dL |
16.29 ± 1.30 |
13.64 i 0.55 |
4 |
Erythrocyte sedimentation rate (ESR) |
mm/h |
1.81±0.25 |
4.18 ± 0.75 |
5 |
Mean corpuscular volume (MCV) |
FI |
11.77 ± 1.77 |
139.88±10.00 |
6 |
Mean corpuscular haemoglobin (MCH) |
Pg |
24.94±2.88 |
35.41±0.79 |
7 |
Heinz bodies |
% of erythrocytes |
0.00±0.00 |
89.25±2.50 |
Mean± Standard error
Table II Haematological Findings in Female Mice Fed with Metanil Yellow at 0.0 and 3.0 G/Kg Body Weight Concentrations
No. |
Experiment |
SI Unit |
0 mg/Kg bw |
3000 mg/Kg bw |
1 |
Total erythrocyte count (TEC) |
1012/L |
5.26±0.37 |
3.49 ± c0.21 |
2 |
Differential leukocyte count (DLC) Neutrophils Lymphocytes Monocytes Eosinophils Basophils |
109/L |
5.14 ± 0.28 3.09 ± 0.19 0.40 ± 0.04 0.04 ± 0.01 0.00 ± 0.00 |
0.32 ± 0.11 9.20 ± 0.54 0.69 ± 0.06 0.01 ± 0.00 0.01 ± 0.00 |
3 |
Haemoglobin (Hb) |
g/dL |
13.54 ± 1.10 |
10.50 ± 1.00 |
4 |
Erythrocyte sedimentation rate (ESR) |
mm/h |
2.21 ± 0.30 |
4.31 ± 0.25 |
5 |
Mean corpuscular volume (MCV) |
FI |
74.10 ± 5.40 |
151.86 ± 4.20 |
6 |
Mean corpuscular haemoglobin (MCH) |
Pg |
25.76 ± 2.97 |
33.23 ± 0.47 |
7 |
Heinz bodies |
% of erythrocytes |
0.00 ± 0.00 |
81.75 ± 2.25 |
Mean± Standard error
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- mouse
- Quality of whole database:
- Data is from K2 publication
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
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
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: dermal
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
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
Various experimental studies for
target substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (CAS
No. 587-98-4) has been investigated for potential of toxicity following
repeated exposure via oral route and are presented below:
Sub-chronic oral toxicity study was performed by Prasad and Rastogi (Toxicology letters, 1983) to determine the oral toxic nature of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (metanil yellow) upon repeated exposure for 180 days. The test compound was force fed to male and female albino mice by oral intubation at a dose levels of 0, 100, 500 or 3000 mg/Kg bw. The animals were observed for general condition, changes in hematological parameters and gross pathology. General condition was unaffected at dose levels of 100 and 500 mg/Kg bw except at 3000 mgKg bw. No change was observed by the 100 and 500 mg/Kg bw but feeding of this colour at the rate of 3000 mg/kg body weight led to certain changes in the haematological values. Total erythrocyte count (TEC) and Hb had decreased whereas ESR, MCV, and mean corpuscular haemoglobin (MCH) had increased. These facts suggested the occurrence of normochromic macrocytic anaemia. Differential leukocyte count (DLC) showed marked increase in the number of lymphocytes and monocytes and decrease in the number of neutrophils and eosinophils. Heinz bodies were observed in 80-90% erythrocytes. Other haematological values like total leukocyte count (TLC), platelet count (PC), PCV, MCHC, bleeding time (BT) and coagulation time (CT) were normal at 3000 mg/Kg bw. Hence, the No Observed Adverse Effect level (NOAEL) for the test compound metanil yellow is 500 mg/Kg bw.
Subacute oral toxicity study was performed by Ramchandani et al (Journal of Applied Toxicology, 1996) to determine the oral toxic nature of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (metanil yellow) upon repeated exposure for 3, 7 and 15 days. The test compound was given to Male Wistar Albino rats by oral intubation at a dose of 430 mg/Kg bw.Post-mitochondrial, microsomal and cytosolic fractions from the liver and gastrointestinal tract and were observed for clinical chemistry parameters including N-Demethylation of aminopyrine (APD), Azo reductase, Aniline hydroxylase, aryl hydrocarbon hydroxylase (AHH) activity, De-ethylation of 7-ethoxyresorufin (ERD), Cytochrome P-450, Glutathione-S-transferase, Quinone reductase (QR), Reduced glutathione content (GSH) and lipid peroxidation (LPO) and protein content. Oral administration of Metanil yellow for 7 days caused significant depletion of hepatic and intestinal glutathione levels (33–52%) with a concomitant increase in lipid peroxidation (49–121%). Metanil yellow treatment for 7 days also led to a significant increase in cytochrome P-450 (P-450)-dependent aryl hydrocarbon hydroxylase (AHH) activity (99–223%) in the liver and intestine. Cytosolic glutathione-S-transferase (GST) (32–136%) and quinone reductase (QR) (20–92%) activities were also found to be substantially induced in hepatic and intestinal tissues following oral treatment of Metanil yellow. Also oral treatment of Metanil yellow showed a greater response in cytosolic enzymes of hepatic tissue as compared to intestine. Based on the observations made, the Low Observed Adverse Effect level (LOAEL) for the test compound metanil yellow is determined to be 430 mg/Kg bw.
Repeated dose chronic toxicity study was performed by Rituparna Sarkar and Apurba Ratan Ghosh (International Journal Of Scientific Research, Volume-6, Issue-5, May - 2017) to determine the oral toxic nature of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (metanil yellow). The study was performed using Albino rats. After acclimatization under laboratory condition for one week they were divided into three groups containing five animals in each: Group I (control) and Group II & III (treated). The test animals of Group II & III were fed orally with a sublethal dose of Metanil Yellow of 3000 mg/kg body weight for a period of 30 and 45 days respectively. Histopathological changes in the spleen tissue were observed under light microscope after staining with Haematoxylin-Eosin. Owing to 30 days of toxicity of Metanil Yellow very minute degenerative changes were found in the white pulp and red pulp of spleen. Trabeculae and follicular regions were rarely damaged. But significant distortion and denerative changes were found in the white pulp and red pulp regions after 45 days treatment. Significant pathological changes were not only observed in the white pulp and red pulp regions of spleen tissue of albino rat but also in the follicles and trabeculae. The damage in the spleen tissue due to Metanil Yellow toxicity varies with both concentration and exposure periods (30 and 45 days). Based on the observations made, The Low Observed Adverse Effect Level (LOAEL) for metanil yellow is considered to be 3000 mg/Kg bw/day.
As per the data available for the target chemical metanil yellow NOAEL value range can be close to 500 mg/Kg bw. Based on the observations made, Metanil yellow does not exhibit toxicity upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route.
Repeated dose toxicity: inhalation
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 sodium
3-[(4-anilinophenyl)diazenyl]benzenesulfonate, which is reported as
6.93E-16 Pa. Thus, exposure to inhalable dust, mist and vapour of the
chemical sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate is highly
unlikely. Therefore this study is considered for waiver.
Repeated dose toxicity: dermal
The acute toxicity value for
sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (as provided in
section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that
sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate shall not exhibit
28 day repeated dose toxicity by the dermal route. In addition, there is
no dermal absorption data as well as no data available that suggests
that sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate shall exhibit
repeated dose toxicity by the dermal route. Hence this end point was
considered for waiver.
Justification for classification or non-classification
The data available for the target chemical metanil yellow is insufficient to classify the chemical as toxic. Also the NOAEL value range can be close to 500 mg/Kg bw. Based on the observations made, Metanil yellow does not exhibit toxicity upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route.
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