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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study was conducted according to the following Good Laboratory Practices: - “OECD Principles of Good Laboratory Practice” Organisation for Economic Co-operation and Development, ENV/MC/CHEM (98)17 (as revised in 1997) This study was conducted according to the following test guideline: - “OECD Guideline for Testing of Chemicals 423, Acute Oral Toxicity-Acute Toxic Class Method” Organisation for Economic Co-operation and Development (Adopted: 17th December 2001)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- 2.3.1 Species, Strain Rat, Sprague-Dawley (Crl:CD(SD)), SPF
2.3.2 Producer & supplier ORIENTBIO INC., Korea
2.3.3 Justification for species selection
Sprague-Dawley rats are commonly used in toxicity studies with a large historical control data base.
2.3.4 Sex, number, age and the body weight range (at receipt)
Females, 13 rats, 7 weeks old, 166.0–176.7 g
2.3.5 Sex, number, age and the body weight range (on administration)
Females, 12 rats, 8–9 weeks old, 173.9–214.0 g
2.4.1 Quarantine room No. A315
2.4.2 Animal room No. A323
2.4.3 Type & size of a cage Stainless wire mesh cage, 260W×350D×210H (mm)
2.4.4 Number of animals per cage One animal/cage (during the study)
2.4.5 Temperature 21.0–24.4°C
2.4.6 Relative humidity 43.3–62.9%
2.4.7 Air changes 10–15 clean, fresh, filtered air changes per hour
2.4.8 Lighting 12 hour light / dark cycle
(7 AM to 7 PM via automated timer)
2.4.9 Intensity of illumination 150–300 Lux
2.4.10 Cage washing Every two weeks
Cages and feeders were washed in the cage washer and sterilized by an autoclave.
Administration / exposure
- Route of administration:
- other: gastric intubation
- Vehicle:
- water
- Details on oral exposure:
- 2.7.1 Route
Oral via gastric intubation
2.7.2 Justification for the route of administration
The oral route was chosen to assess the toxicity by oral exposure of the test substance.
2.7.3 Method of administration
Individual doses were calculated based on the animals body weight recorded just prior to dosing at a dose volume of 10 mL/kg body weight. Animals were dosed via gastric intubation with 3 mL disposable syringes fitted with intubation tubes. Animals were fasted overnight, approximately 16 hours prior to dosing. Drinking water was provided ad libitum. Feed was provided approximately 4 hours post dosing. - Doses:
- 300mg/kg, 2000mg/kg
- No. of animals per sex per dose:
- 3F
- Control animals:
- no
- Details on study design:
- The starting dose level for this study was selected at 300 mg/kg, since there was no
available information on the toxicity of the test substance.
The following sequential dosing steps were based on mortality and clinical observations for 2 to 5 days after the previous dose level. The following dosage regimen was selected according to the ‘ANNEX 2c : TEST PROCEDURE WITH A STARTING DOSE OF 300 MG/KG BODY WEIGHT’.
2.9 Parameters Evaluated
2.9.1 Clinical signs
All animals were observed for mortality, general condition and clinical signs (time, onset, severity and recovery) at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Days 1 to 14).
2.9.2 Disposition of dead animal
During the observation period, necropsy was done on one animal found dead immediately after body weight measurement.
2.9.3 Body weights
Body weights were recorded prior to dosing (Day 0), on Days 1, 3 and 7 and on the day of necropsy, Day 14.
2.9.4 Necropsy
On Day 14, all surviving animals were anesthetized with CO2 and exsanguinated from the abdominal aorta. Complete gross postmortem examinations were performed on all animals in the study.
2.9.5 Histopathology
Since no gross findings were observed at necropsy, histopathological examinations were not performed at 300 mg/kg.
Histopathological evaluations were performed on the forelimb, jejunum, skin and/or stomach. There was a visible indication of morphologic abnormalities in one dead animal and two surviving animals at 2,000 mg/kg. - Statistics:
- Statistical analysis was not performed. Mean scores and values are presented.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals at 300 mg/kg survived the duration of the study. There were no effects on the mortality.
One animal at 2,000 mg/kg was found dead on Day 2 after dosing. It was considered to be under the effect of the test substance. - Clinical signs:
- There was no death in any animals at 300 mg/kg. Irregular respiration was evident in all animals at 300 mg/kg on the day of dosing and on Day 1 after dosing. These animals returned to a normal appearance on Day 2 after dosing.
In one dead dosed with 2,000 mg/kg, irregular respiration and compound-colored stool were evident on the day of dosing and on Day 1 after dosing. Irregular respiration decrease of fecal volume, hypothermia, incised wound (left forelimb, right forelimb), paleness, refusal to feed, scratched wound (abdomen), self biting and in a state of lying on side were evident on Day 2 after dosing. Then, one animal was found dead on Day 2 after dosing. In five surviving animals at 2,000 mg/kg, irregular respiration was evident on the day of dosing. In three surviving animals at 2,000 mg/kg, irregular respiration and/or compound-colored stool were evident from Day 1 to Day 2 after dosing. Then, these animals returned to a normal appearance on Day 3 after dosing. In two surviving animals at 2,000 mg/kg, irregular respiration, compound-colored stool, decrease of fecal volume, hypothermia, incised wound (left forelimb, right forelimb), paleness, decrease in food consumption, blackish stool, piloerection and/or self biting were evident from Day 1 to Day 6 after dosing. Crust formation (left forelimb, right forelimb) was evident from Day 3 to Day 14 after dosing. - Body weight:
- Normal body weight gain was evident in all animals at 300 mg/kg.
A tendency to suppress body weight gain was evident in all surviving animals on Day 1 and/or on Day 3. The decrease in body weight was evident in four animals on Day 3 after dosing at 2,000 mg/kg. Then, five animals returned to normal on Day 7. These changes were considered to be test substance-related effects. - Gross pathology:
- No remarkable findings were noted in all remaining females at 2,000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Based on the results of the acute oral toxicity study in Sprague-Dawley rats, GHS classification of the test substance, CMS Red 620, was classified to be Category 5.
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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