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Diss Factsheets
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EC number: 223-098-9 | CAS number: 3734-67-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: Chronic
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
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:
- Chronic repeated dose oral toxicity study of RED 2G in rats
- GLP compliance:
- not specified
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:
- C18H15N3O8S2.2Na
- IUPAC Name:
- disodium 5-acetamido-4-hydroxy-3-(phenyldiazenyl)naphthalene-2,7-disulfonate
- Reference substance name:
- Red 2G
- IUPAC Name:
- Red 2G
- Details on test material:
- - Name of test material (as cited in study report): RED 2G- Molecular formula (if other than submission substance): C16-H12-N2-O4-S.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
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- 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:
- No data available
- Details on mating procedure:
- Details on study schedule- F1 parental animals not mated until [...] weeks after selected from the F1 litters.- Selection of parents from F1 generation when pups were [...] days of age.- Age at mating of the mated animals in the study: [...] weeks(Explain how study was performed on perents and offspring separately whatever information we have): No data available- M/F ratio per cage::No data available - Length of cohabitation::No data available - Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancyNo data available - After ... days of unsuccessful pairing replacement of first male by another male with proven fertility.:No data available - Further matings after two unsuccessful attempts: [no / yes (explain)]:No data available - After successful mating each pregnant female was caged (how)::No data available - Any other deviations from standard protocol:: Reproductive organ weight was weighted.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:0, 24 and 114 ppm (0, 2.4 and 11.4 mg/kg bw/day)Basis:
- No. of animals per sex per dose:
- Total:1440 mg/kg bw/day: 24 mal;e , 24 female 2.4 mg/kg bw/day: 24 mal;e , 24 female11.4 mg/kg bw/day: 24 mal;e , 24 female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Clinical sign, body weight, Food intake, haematology, clinical chemistry and refractive index of the urine were examined.
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Organ function and weight, and histopathology were examined.
- 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
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 11.4 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No effect on reproductive organ weight
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
Effect levels (F1)
- Remarks on result:
- not determinable
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 11.4 mg/kg bw/day for male rats when male and female rats were treated with RED 2G.
- Executive summary:
In Chronic repeated dose oral toxicity study, male and female rats were treated with RED 2G in the concentration of 0, 24 and 114 ppm in cooked sausage. No effect obn 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 and 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 but no effect were observed on testes of male rats. Therefore, NOAEL was considered to be 11.4 mg/kg bw/day for male rats when male and female rats were treated with RED 2G orally in deit for 13 weeks.
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