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Diss Factsheets
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EC number: 946-752-1 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1994-10-25 and 1994-11-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Direct Red 227:1 – Similar Substance 01
- IUPAC Name:
- Direct Red 227:1 – Similar Substance 01
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate, Kent, U.K.
- Age at study initiation: approx. 5 to 8 weeks
- Weight at study initiation: males 150 - 160 g, females 148 - 166 g
- Fasting period before study: overnight fast immediately before dosing, approx. 2 h after dosing
- Housing: housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet: rat and mouse expanded diet no. 1, special diets services limited, Witham, Essex, U.K., ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 22
- Humidity (%): 48 - 56
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: 1/2, 1, 2 and 4 hours after dosing, subsequently once daily; weighing: before experiment, on day 7 and 14
- range-finding study was performed to define the dose level for the main study
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, body weight - Statistics:
- not required
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systematic toxicity were noted during the study. Dark red staining of the fur was noted in all males from 1-hour observation to the day 1 observation, and in one female at the 4-hour and 1 day observations.
- Gross pathology:
- No abnormalities were noted at necroscopy.
Applicant's summary and conclusion
- Interpretation of results:
- other: GHS criteria not met
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
An acute oral toxicity study was perfomed by using Sprague-Drawley strain rats. Based on the results of the range-finding study, the test substance (49 % act. integr.) was administered by gavage to 5 animals per 5 sex in doses of 2000 mg/kg bw. The animals were observed for mortality and signs of toxicity 1/2, 1, 2 and 4 hours after dosing and subsequently once daily for 14 days. The results indicated no deaths. No signs of systemic toxicity were noted during the study. Dark red staining of the fur was noted in all males from the 1 -hour observation to the day 1 observation, and in one female at the 4 -hour and 1 day observations. Individual bodyweights were recorded prior to dosing on Day 0 and on Day 7 and 14. All animals showed expected gain in bodyweight during the study. No abnormalities were noted necropsy. The acute oral LD50 of the test material in rats was found to be greater than 2000 mg/kg bw.
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