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Diss Factsheets
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EC number: 227-497-9 | CAS number: 5858-81-1
- 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
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Endpoint summary
Administrative data
Description of key information
Acute oral toxicity:
LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- 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 Authorized database
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Acute oral toxicity study of Lithol Rubine B in rat
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Lithol Rubine B - Molecular formula (if other than submission substance):C18H14N2O6S.2Na- Molecular weight (if other than submission substance):432.38 g/mole- Substance type:Organic
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- not specified
- Route of administration:
- oral: unspecified
- Vehicle:
- not specified
- Details on oral exposure:
- not specified
- Doses:
- 10800 mg/kg bw
- No. of animals per sex per dose:
- not specified
- Control animals:
- not specified
- Details on study design:
- not specified
- Statistics:
- not specified
- Preliminary study:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 10 800 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No mortality was observed in treated rat at 10800 mg/kg bw
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.
- Executive summary:
In a acute oral toxicity study, rat were treated with Lithol Rubine B in the concentration of 10800 mg/kg bw,No mortality was observed in treated rat at 10800 mg/kg bw. Therefore,LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 10 800 mg/kg bw
- Quality of whole database:
- Data is Kimisch 2 and from Authorized database
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
In different studies, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate has been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats and mice for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate along with the study available on structurally similar read across substance Carmoisine (CAS: 3567-69-9). The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.
In a experimental study summarized by CCOSH (Canadian Centre for Occupational Health & Safety, RTECS Number QJ1975000, 2017) and Scientific Committee on Cosmetic Products (COLIPA, SCCNFP, 2004), rat were treated with Lithol Rubine B in the concentration of 10800 mg/kg bw, No mortality was observed in treated rat at 10800 mg/kg bw. Therefore, LD50 was considered to be > 10800 mg/kg bw when rat was treated with Lithol Rubine B orally.
In another prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate. The LD50 was estimated to be 7649 mg/kg bw when rats were orally exposed with disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate.
In another experimental study conducted by Gauntet al(Food Cosmetics. Toxicology. Vol. 5, pp. 179-185. 1967) on structurally similar read across substance Carmoisine (CAS no 3567-69-9), ICI Alderley Park male and female mice were treated with Carmoisine upto 8000 mg/kg orally by gavage in water and observed for 7 days. No mortalities were observed in any of the animal upto dose 8000 mg/kg. Therefore, LD50 was considered to be > 8000 mg/kg bw when ICI Alderley Park male and female mice were treated with Carmoisine orally by gavage.
Further supported by experimental study conducted by Lamiaet al(International Journal of Pharm Tech Research,Vol.9, No.4, pp 364-367, 2016) on structurally similar read across substance Carmoisine (CAS no 3567-69-9), Sprague- Dawly white male mice were treated with Carmoisine in the concentration of 1250,2500,3750,5000 and 6250 mg/kg orally. At 3750 mg/kg, 2 mice were died, at 5000 mg/kg , 5 mice were died and at 6250 mg/kg, 6 mice were died. Signs of loss of appetite drowsiness, tachycardia, decrease in locomotion & anorexia was distinctive signs were observed in the dead mice. Therefore, LD50 was considered to be 4166.66 mg/kg bw when male mice were treated Carmoisine orally.
Thus, based on the above studies and predictions on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be classified as category V of acute oral toxicity.
Justification for classification or non-classification
Based on the above studies and predictions on disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate and its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, disodium 4-[(E)-2-(4-methyl-2-sulfophenyl)diazen-1-yl]-3-oxidonaphthalene-2-carboxylate can be classified as category V of acute oral toxicity.
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