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EC number: 228-770-5 | CAS number: 6358-36-7
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from assessment report
Data source
Reference
- Reference Type:
- secondary source
- Title:
- OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID RED 52
- Author:
- THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP)
- Year:
- 2 004
- Bibliographic source:
- THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS (SCCNFP) /0803/ 23 April 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Female rats were administered Acid Red 52 by gavage for examining its Reproductive/Developmetal toxicity potential.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt
- EC Number:
- 222-529-8
- EC Name:
- Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt
- Cas Number:
- 3520-42-1
- Molecular formula:
- C27H30N2O7S2.Na
- IUPAC Name:
- sodium 4-[3,6-bis(diethylamino)-2,7-dimethylxanthenium-9-yl]benzene-1,3-disulfonate; 2-(3-diethylamino-6-diethylazaniumylidene-xanthen-9-yl)-5-sulfo-benzenesulfonate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):Acid Red 52
- Molecular formula : C27H30N2O7S2.Na
- Molecular weight : 580.6551 g/mol
- Substance type:Organic
Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Acid Red 52
- Molecular formula : C27H30N2O7S2.Na
- Molecular weight : 580.6551 g/mol
- Substance type: Organic
- Physical state: solid
- Impurities (identity and concentrations): 80% (± 3%)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- not specified
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- not specified
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: (bi-distilled water containing 1% carboxymethyl cellulose sodium salt
- Details on exposure:
- not specified
- Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 20 dyas
- Frequency of treatment:
- daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5 females / dose level
- Control animals:
- yes
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Parental animals: Observations and examinations:
- Clinical signs
- Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- not specified
- Postmortem examinations (parental animals):
- the animals were killed and examined macroscopically. Foetuses were removed by Caesarean section.
- Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Violet discoloured faeces, urine and bedding material were noted from day 7 post coitum till day 19 post coitum in all treatment groups, no reaction to treatment or clinical signs were observed in any female.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No death occurred during the course of the study.
- 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
- Histopathological findings: non-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:
- no effects observed
- Description (incidence and severity):
- The relevant maternal reproductive data (mean number of implantations and live foetuses) were similar in all groups. No external abnormalities were noted in any of the foetuses. The sex ratios were similar in all groups.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- reproductive function (sperm measures)
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: not specified
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on the results described above, 1000 mg/kg bw/day of sodium 4-[3,6-bis(diethylamino)-2,7-dimethylxanthenium-9-yl]benzene-1,3-disulfonate (Acid Red 52) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal/ reproductive toxicity.
- Executive summary:
Three groups of five mated female rats were administered Acid Red 52 by gavage at doses of 100, 300 or 1000 mg/kg bw/day from day 6 through day 17 post coitum. An additional group of five mated rats was administered the vehicle (bi-distilled water containing 1% carboxymethyl cellulose sodium salt) and served as a control group. On day 21 post coitum, the animals were killed and examined macroscopically. Foetuses were removed by Caesarean section. No death occurred during the course of the study. Violet discoloured faeces, urine and bedding material were noted from day 7 post coitum till day 19 post coitum in all treatment groups. The relevant maternal reproductive data (mean number of implantations and live foetuses) were similar in all groups. No external abnormalities were noted in any of the foetuses. The sex ratios were similar in all groups. Based on the results described above, 1000 mg/kg bw/day of sodium 4-[3,6-bis(diethylamino)-2,7-dimethylxanthenium-9-yl]benzene-1,3-disulfonate (Acid Red 52) is considered to be the No-Observable-Adverse-Effect-Level (NOAEL) for the maternal/ reproductive toxicity.
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