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EC number: 269-197-0 | CAS number: 68189-39-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Chronic
- 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 from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Summary of toxicological data of certain food additives
- Author:
- WHO
- Year:
- 1 977
- Bibliographic source:
- WHO FOOD ADDITIVES SERIES NO. 12, INTERNATIONAL PROGRAMME ON CHEMICAL SAFETY WORLD HEALTH ORGANIZATION, 18-27 April 1977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- A repeated dose oral toxicity study of RED 2G in rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- EC Number:
- 223-098-9
- EC Name:
- Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 3734-67-6
- Molecular formula:
- C18H13N3Na2O8S2
- IUPAC Name:
- disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Details on test material:
- - Name of test material (as cited in study report): RED 2G
- Molecular formula (if other than submission substance): C16H12N2O4S.Na
- Molecular weight (if other than submission substance): 350.3289 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): RED 2G
- Molecular formula : C16H12N2O4S.Na
- Molecular weight : 350.3289 g/mole
- Substance type: Organic
- Physical state: No data available
- Impurities (identity and concentrations): No data available
Test animals
- Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data available
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: Cooked sausage
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test material was mixed in a cooked sausage.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): Cooked sausage-
Storage temperature of food: No data availble
VEHICLE
- Justification for use and choice of vehicle (if other than water): Cooked sausage
- Concentration in vehicle: 0, 24 or 114 ppm
-Amount of vehicle (if gavage): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- Doses / Concentrations: 0, 24 or 114 ppm (equal to 0, 2.4 or 11.4 mg/kg bw/day)
- No. of animals per sex per dose:
- Total: 144 animals
Control: 24 males, 24 females
24 ppm; 24 males, 24 females
114 ppm: 24 males, 24 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: yes
- Time schedule:
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): weekly
- 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
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations:
OTHER:After 10-11 days of study initiation, the presence of Heinz bodies was controlled. A liver function test (bromosulfthalein retention test) was carried out after 9 weeks, and after 12 weeks the refractive index of the urine was measured. Prior to sacrifice, a detailed hematological investigation was done. - Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- SACRIFICE yes
- Male animals: All surviving animals [describe when, e.g. as soon as possible after the last litters in each generation were produced.]
- Maternal animals: All surviving animals [describe when, e.g. after the last litter of each generation was weaned.]
GROSS NECROPSY
- Gross necropsy consisted of [external and internal examinations including the cervical, thoracic, and abdominal viscera.]At post-mortem, the weights of the spleen, kidneys, liver, heart and testes were determined.
HISTOPATHOLOGY / ORGAN WEIGHTS
The tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively.: No data - Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No effect on growth of treated rats were observed as compared to control. Loss of hair in treated rats were observed.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on growth was observed.
- 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:
- no effects observed
- Description (incidence and severity):
- Blood test revealed no evidence of toxicity.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No effect on liver function test (bromosulfthalein retention test) were observed in treated rats as compared to control.
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated 114 ppm, increased erythropoiesis, increased splenic red pulp hemosiderin and increased splenic red pulp reticular impregnation with iron were observed in treated rats as compared to control.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 114 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No adverse effect on reproductive organ weight.
- Remarks on result:
- other: No effects on reproductive organ weight
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- not determinable
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 114 mg/kg bw for male rats when male and female rats were treated with RED 2G for 13 weeks.
- Executive summary:
In a repeated dose oral toxicity study, male and female rats were treated with RED 2G (3734 -67-6) in the concentration of 0, 24 or 114 ppm in cooked sausage. No effect on growth of treated rats were observed. Loss of hair in many treated rats were observed. No effect on liver function test (bromosulfthalein retention test) were observed in treated rats as compared to control. Similarly, no effect on spleen, kidneys, liver, heart or testes weight were observed in treated rats as compared to control. Increased erythropoiesis, increased splenic red pulp haemosiderin and increased splenic red pulp reticular impregnation with iron were observed in treated rats as compared to control. In addition, no effect was observed on testes weight of male rats. Therefore, NOAEL was considered to be 114 ppm for male rats when male and female rats were treated with RED 2G orally in diet for 13 weeks.
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