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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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:
- 25 November 2008 and 11 December 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols with no deviations from standard test guidelines and/or minor methodological deficiences which do not affect the quality of the relevant results
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Details on test material:
- Dark red powder
Batch Number MB-1-A
Storage room temperature in dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 142-176 g
- Fasting period before study: Overnight fast immediately before dosing
- Housing: Groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): Free access to 2014 Teklad Global Rodent diet
- Water (e.g. ad libitum): Free access to mains drinking water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 dark:12 light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
2000 mg/kg was chosen dose: 2000 mg/kg dose level, 200 mg/mL concentration, 10 mL/kg dose volume.
Animals were dosed once by gavage using a metal cannula attached to a graduated syringe.
Volume administered to each animal was calculated according to fasted bodyweight at time of dosing.
MAXIMUM DOSE VOLUME APPLIED:
10mL/kg
DOSAGE PREPARATION (if unusual):
For the purpose of the study the test material was freshly prepared, as required, as a solution in distilled water.
Determination by analysis of the concentration, homogeneity and stability of the test material preparations was not appropriate because it was not specified in the Study Plan and is not a requirement of the Test Guideline.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose. In the absence of toxicity at a dose level of 2000 mg/kg, an additional group of animals was treated in the same manner. A total of five animals were therefore treated at a dose level of 2000 mg/kg in the study - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5f
- Control animals:
- no
- Details on study design:
- - Frequency of observations and weighing: Clinical observations were made 0.5, 1, 2, and 4 hours after dosing and subsequently once daily
for fourteen days. Morbidity and mortality checks were made twice daily.
- Necropsy of survivors performed: Yes, this consisted of an external examination and opening of the abdominal and thoracic cavities. The
appearance of any macroscopic abnormalities was recorded. No tissues were retained. No abnormalities were detected.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Effects on bodyweights and abnormalities
noted at necropsy were also identified. All animals showed expected gains in bodyweight over the observation period. - Statistics:
- N/A
Results and discussion
- Preliminary study:
- Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose. 1 rat was preliminary dosed at 2000 mg/kg followed by 4 rats to make up a dose group of 5 rats.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deatjs
- Clinical signs:
- No signs of systemic toxicity were noted. Red stained faeces was noted in all animals during the study.
- Body weight:
- All animals showed expected gains in bodyweight over the observation period
- Gross pathology:
- No abnormalities were noted at necropsy.
Any other information on results incl. tables
The acute oral median lethal dose (LD50) of test material in female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information No signs of toxicity Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg
bodyweight. - Executive summary:
In an Acute oral toxicity in the rat – fixed dose method study (Harlan project number: 0959/0236) the test material was determined to have an LD50 of greater than 2000 mg/kg bodyweight. There were no deaths. No signs of systemic toxicity were noted. Red stained faeces was noted in all animals during the study. All animals showed expected gains in bodyweight over the observation period. There were no abnormalities noted at necropsy.
The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:
- OECD Guidelines for Testing of Chemicals No 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 17 December 2001).
- Method B1 bis AcuteToxicity (Oral) ofCommissionDirective2004/73/EC.
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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