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Diss Factsheets
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EC number: 215-724-4 | CAS number: 1390-65-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study will be available 30/08/2019
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Carmine
- EC Number:
- 215-724-4
- EC Name:
- Carmine
- Cas Number:
- 1390-65-4
- Molecular formula:
- C22H20O13
- IUPAC Name:
- Carmine
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain Rat, Hsd: Sprague Dawley SD
Sex: Females (nulliparous and non-pregnant)
Age: 6 to 7 weeks old
Weight range at arrival: 155 to 160 grams
Acclimatisation period: At least 5 days
Veterinary health check: During acclimatisation period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Dosing method: The formulated test item was administered, by gavage, at a dose volume of 20 mL/kg using a plastic feeding tube attached to a graded syringe.
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- An initial sighting study was performed on a single female animal which was dosed at 2000mg/kg. No mortality occurred and the animal was observed for a period of 14 days. A main study was then performed on a group of 4 females, dosed at 2000mg/kg and observed for a period of 14 days.
- Control animals:
- no
- Details on study design:
- Frequency of treatment: Once only, on the day of dosing.
Fasting procedure: Food was removed fromthe cages overnight prior to dosing (Day -1) and was made available approximately 4 hours after dosing.
Dose calculation: On the day of dosing (Day 1), the amount of the formulated test item to be administered was calculated for each fasted animal according to body weight.
Dosing method: The formulated test item was administered, by gavage, at a dose volume of 20 mL/kg using a plastic feeding tube attached to a graded syringe
Results and discussion
- Preliminary study:
- An initial sighting study was performed on a single female animal which was dosed at 2000mg/kg. No mortality occurred and the animal was observed for a period of 14 days.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality and morbidity: Throughout the study all animals were checked twice daily.
- Clinical signs:
- other: Clinical signs Animals were observed for clinical signs as indicated below: – Day of dosing – · Session 1: on dosing – · Session 2: approximately 0.5 hour after dosing – · Session 3: approximately 2 hours after dosing – · Session 4: approximately 4 hours
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required
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