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Diss Factsheets
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EC number: 916-603-5 | CAS number: -
- 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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to OECD guideline 414 in compliance to GLP.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Multi constituent substance
- EC Number:
- 916-603-5
- IUPAC Name:
- Multi constituent substance
- Details on test material:
- Test substance : Basic Red 76 (COLIPA number C008)
Batch number : 12/13B
Methylsulphate anion : 11.4%
Chloride ion : 4.4%
Water : 3.1%
o-Anisidine : 11ppm
Purity : 98.5% (HPLC)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Milli-U water
- Details on exposure:
- Dose levels were based on the results of a range-finding study.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Animals were treated on day 6-20 of gestation
- Frequency of treatment:
- Animals were treated once daily
- Duration of test:
- Animals were sacrificed on day 21 of gestation
- No. of animals per sex per dose:
- Twenty four females per dose group
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- The mortality and the body weight gain were observed daily. Females were checked daily for the presence of clinical signs. Body weights and food consumption of females were determined at periodic intervals. On day 21 all females were subjected to post-mortem examination. External, thoracic and abdominal macroscopic findings were recorded.
- Ovaries and uterine content:
- The ovaries and uterine horns were dissected and examined for the number of corpora lutea, the weight of the gravid uterus, the number of implantation sites, the number and distribution of live/dead foetuses, the weight of each live foetus and corresponding placenta, foetal sex and externally visible foetal macroscopic abnormalities. Alternate foetuses of each litter were preserved and subjected to skeletal or visceral examinations.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 60 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: reduction in foetal body weight
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
At the low dose group (60 mg/kg bw/day) no maternal, reproductive or developmental toxicity was observed. At the intermediate dose level (250 mg/kg bw/day) maternal toxicity consisted of decreased body weights, body weight gain, for uterus corrected body weight gain and decreased (absolute and relative) food consumption. At the 250 mg/kg bw/day dose level developmental toxicity consisted of decreased foetal body weights and decreased placental weights. At the high dose level (1000 mg/kg bw/day) maternal toxicity consisted of decreased body weights, body weight gain, for uterus corrected body weight gain and decreased (absolute and relative) food consumption. Also at the 1000 mg/kg bw/day there were slight increases in thinning of the central tendon region of the diaphragm and left sided umbilical artery. The incidences of two other visceral observations also showed minimal changes namely an increase in the incidence of foetuses with extension of one or both lobes of the thymus gland into the neck region and absence of foetus with distension of the urinary bladder. A similar but more pronounced atypical ossification pattern (see 250 mg/kg bw/day) was seen. Generally minor changes in thoracic centra slightly above the historical control range are considered to be of no toxicological significance. Based on available data in the study no explanation can be given for the observation that some toxicological findings (maternal body weights and food consumption, foetal body weights, placental weights) were more pronounced at the 250 mg/kg bw/day dose level when compared to the 1000 mg/kg bw/day dose level.
Applicant's summary and conclusion
- Conclusions:
- The NOAEL for maternal toxicity and developmental toxicity was 60 mg/kg bw/day.
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