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EC number: 235-469-2 | CAS number: 12237-63-7 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 45160:2.
- 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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- 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 from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Scientific Committee on Consumer Products, Opinion on:test material
- Author:
- European Commission (EC) - Scientific Committee on Consumer Products (SCCP)
- Year:
- 2 008
- Bibliographic source:
- Scientific Committee on Consumer Products (SCCP),2008
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Principles of method if other than guideline:
- Teratogenic toxicity study of test material was performed on rats.
- GLP compliance:
- not specified
- Limit test:
- no
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
- 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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: bi-distilled water containing 1% carboxymethylcellulose sodium salt
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test material dissolved in bi-distilled water containing 1% carboxymethylcellulose
sodium salt
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- No data available
- Duration of treatment / exposure:
- 11 days (from day 6 through day 17 post coitum)
- Frequency of treatment:
- Daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- 0, 100, 300, 1000mg/kg bw/day
- No. of animals per sex per dose:
- Total: 88
0 mg/kgbw/day: 22 female
100 mg/kgbw/day: 22 female
300 mg/kgbw/day: 22 female
1000 mg/kgbw/day: 22 female - Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Animals were checked twice daily for mortality/morbidity, and once daily for clinical signs.
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: body weight were recorded at designated intervals during pregnancy
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes :Food consumption were recorded at designated intervals during
pregnancy
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
POST-MORTEM EXAMINATIONS: Yes / No / No data
- Sacrifice on gestation day #
- Organs examined:
OTHER: - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
- Head examinations: No data - Statistics:
- No data available
- Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Clinical signs were restricted to discoloration of urine and faeces.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- All animals survived until caesarean section
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- body weighty were not affected by the test substance administration
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption were not affected by the test substance administration
- 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
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No abnormal macroscopically findings were noted during necropsy
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- The differences amongst the relevant reproduction data (post-implantation loss, number of implantations and foetuses) of the vehicle control group and the dose groups gave no indication of test article related effects.
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- clinical signs
- early or late resorptions
- food consumption and compound intake
- gross pathology
- mortality
- pre and post implantation loss
- total litter losses by resorption
- Remarks on result:
- other: No effects on reproductive performance
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- The mean body weights of foetuses gave no indication of effects caused by administration of the test article.
- Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- the ratio of male and female foetuses gave no indication of effects caused by administration of the test article.
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Description (incidence and severity):
- The external examinations of foetuses gave no indication of effects caused by administration of the test article.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- The skeletal examinations of foetuses gave no indication of effects caused by administration of the test article.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- The visceral examinations of foetuses gave no indication of effects caused by administration of the test article.
- Other effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- visceral malformations
- Remarks on result:
- other: No developmental toxic effects were observed
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw/day for F0 and F1 generation female wistar rats when treated with test material by oral gavage.
- Executive summary:
The teratogenic toxicity study was performed according to OECD 414 guideline. The pregnant female wistar rats were treated with test material in dose concentration 0, 100, 300, 1000 mg/kg bw/day by oral gavage route from day 6 through day 17 post coitum.22 pregnant female /dose group were received test material while a group of 22 pregnant rats received the vehicle only (bi-distilled water containing 1% carboxymethylcellulose sodium salt) and served as a control group. Animals were checked twice daily for mortality/morbidity, and once daily for clinical signs. Food consumption and body weight were recorded at designated intervals during pregnancy. On day 21 post coitum, the animals were killed and examined macroscopically. Foetuses were removed by caesarean section.
All animals survived until caesarean section and with the exception of violet discoloured urine, faeces and bedding material observed in all dosage groups, no reaction to treatment or clinical signs were observed in any female. Food consumption and body weighty development were not affected by the test material administration. No abnormal macroscopically findings were noted during necropsy. The differences amongst the relevant reproduction data (post-implantation loss, number of implantations and foetuses) of the vehicle control group and the dose groups gave no indication of test article related effects. The mean body weights of foetuses, the ratio of male and female foetuses and the results of external, visceral and skeletal examinations of foetuses gave no indication of effects caused by administration of the test material. Hence, NOAEL was considered to be 1000 mg/kg bw/day for F0 and F1 generation female wistar rats when treated with test material by oral gavage.
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