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Diss Factsheets
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EC number: 214-161-1 | CAS number: 1103-39-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well described, comparable with OECD 414, brief data on animals, environmental conditions and diet preparation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Limit test:
- no
Test material
- Reference substance name:
- Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]
- EC Number:
- 225-935-3
- EC Name:
- Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate]
- Cas Number:
- 5160-02-1
- Molecular formula:
- C17H13ClN2O4S.1/2Ba
- IUPAC Name:
- Barium bis{5-chloro-2-[(2-hydroxy-1-naphthyl)diazenyl]-4-methylbenzenesulfonate}
- Test material form:
- solid: nanoform
- Details on test material:
- received from the Sun Chemical Corporation, 06/12/1972
light red powder
"D&C Red #9 BA LAKE, Brilliant Red C15-019"
Lot. No Y2314
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD rats
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Charles River
- Housing: individually after mating
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
in a temperature and humidity controlled room
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % methocel
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
suspended in 0.5% Methocel
constant administration of 1 ml/100 g bw
VEHICLE
Dow's Methocel 90 HG Premium l5,000 CPS - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 2 females and one male
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- days 6 through 15 of gestation
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1.5, 5, 15 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
- other: positive control retinoic acid 7.5 mg/kg bw
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily during the gestation period for pharmacodynamic signs or evidence of miscarriage
BODY WEIGHT: Yes
- Time schedule for examinations: Body weights were recorded on days 0, 6, 12, 15 and 20 of gestation.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day: The female rats were sacrificed with chloroform and Cesarean sections performed on day 20 of gestation - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: No data
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes:
- sexed, examined for external abnormalities and weighted
- 1/3 examined for visceral absnormalites
- 2/3 examined for skeletal abnormalities - Historical control data:
- no data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No changes in behavior or appearance considered to be related to D & C Red #9 were observerd.
Increases in body weight were similar for control and treated rats.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No compound related effect upon any fetal parameters evaluated (number of alive and dead pups, mean body weight, sex, external, interaal and skeletal abnormalities)
Effect levels (fetuses)
- Dose descriptor:
- other:
- Basis for effect level:
- other:
- Remarks on result:
- not determinable
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.