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Diss Factsheets
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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 January 2015 to 11 February 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test item: Disperse Blue CVG
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Italia S.p.A., Calco (Lecco), Italy
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 193 - 203 g at allocation
- Fasting period before study: Food was removed from the cages overnight prior to dosing and was made available approximately 4 hours after dosing.
- Housing: 3 animals/cage during the study; up to 5 animals/cage during acclimatisation in polisulphone solid bottomed cages with nesting material provided
into suitable bedding bags
- Diet (e.g. ad libitum): ad libitum throughout the study except for the fasting period prior to dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C +/- 2 °C
- Humidity (%): 55% +/- 15%
- Air changes (per hr): Approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): Artificial (fluorescent tubes), daily light/dark cycle of 12/12 hours
IN-LIFE DATES: From: 21 January 2015 (allocation of the animals to the first group) To: 11 February 2015 (last necropsy procedure)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PEG 400 - water 1:1 v/v
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- Mortality and morbidity
Throughout the study all animals were checked twice daily.
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 after dosing
– Daily thereafter for a total of 14 days
Body weight
All animals were weighed at allocation to the study (Day -1), on the day of dosing (Day 1) and on Days 2, 8 and 15.
Body weight change calculated for Days 2, 8 and 15 of the dosing phase was related to Day 1 of the phase.
All animals were sacrificed on Day 15 by carbon dioxide narcosis.
Necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the
gastro-intestinal tract).
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in the first group of animals initially dosed at 2000 mg/kg body weight (Step 1) and in the second group of 3 females dosed at the same dose level (Step2).
- Clinical signs:
- No clinical signs were observed. Slight to marked green colouration of faeces, due to the colour of the substance, was observed on Days 2 or 3 of the study.
- Body weight:
- Changes in body weight observed during the study were within the expected range for this strain and age of animals.
- Gross pathology:
- No abnormalities were observed at necropsy examination performed on all animals dosed at 2000 mg/kg body weight at the end of the observation
period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- These results indicate that the test item Disperse Blue CVG did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg body weight. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.
European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and
subsequent revisions) would indicate the following:
Classification: No category
Signal word: No signal word required
Hazard statement: No hazard statement required - Executive summary:
The acute toxicity of Disperse Blue CVG was investigated following a single oral administration to the Sprague Dawley rat followed by a 14-day observation period.
A first group of 3 female animals was initially dosed at 2000 mg/kg body weight (Step 1). No mortality occurred and no signs of toxicity were observed. Green coloration of faeces was noted. A second group of 3 female animals was then dosed at the same dose level (Step 2). No death occurred and no signs of toxicity were noted. Green coloration of faeces was observed.
Body weight changes recorded during the study were within the expected range for this strain and age of animals.
No abnormalities were observed at necropsy examination performed at the end of the observation period on animals of both groups.
These results indicate that the test item Disperse Blue CVG did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg body weight. The lack of mortality demonstrates the acute toxicity expected (ATE) to be greater than 2000 mg/kg body weight.
European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:
Classification :No category
Signal word: No signal word required
Hazard statement: No hazard statement required
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.
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