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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:
- 09 August 2013 to 20 January 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant with OECD test guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- To minimise the number of animals used, Group 2 animals were administered at 2000 mg/kg instead of 300 mg/kg. There were no adverse signs so a third group of rats were treated at the same dose level (2000 mg/kg) to complete the study.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Details on test material:
- - Physical state: extremely viscous amber liquid
- Analytical purity:
- Lot/batch No.: E00031-68-1
- Expiration date of the lot/batch: 16 October 2010
- Storage condition of test material:room temperature in the dark, under nitrogen
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot/batch No.of test material: E00031-633
- Retest date of the lot/batch: 04 Febuary 2013
- Purity test date: >/= 99%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Ambient temperature, in the dark
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River, Maragate, UK
- Age at study initiation: 8 to 11 weeks old
- Weight at study initiation: 196.2 to 227.7 g
- Fasting peroid before study: overnight before dosing
- Housing: Housed in groups of 3
- Diet: ad libitum (except fasting period before study)
- Water: ad libitum
- Acclimatisation: At least 9 days before dosing
ENVIRONMENTAL CONDITIONS:
- Temperature: Approximately 20 °C
- Humidity: Approximately 52% to 67%
- Photoperiod: 12 hours light/dark cycle (light hours 0700 to 1900 h)
- Air Changes: 10 air changes per hour
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- TEST ITEM
- Purity: 99%
MAXIMUM DOSE VOLUME APPLIED: 2.1 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg is recommended by the OECD 423 guidelines. - Doses:
- 300 mg/kg followed by 2000 mg/kg
- No. of animals per sex per dose:
- Three groups of three females
- Control animals:
- no
- Details on study design:
- - Housing: The rats were housed in groups of three, 9 days before dosing. Food and water were available ad libitum, except food was withdrawn overnight before dosing. Environmental conditions were monitored and recorded every 15 minutes.
- Observations and weighing: The rats were examined five times on the day of dosing, followed by daily observations up to Day 15. The body weight of the rats were recorded on Day 1 (before dosing), Day 8 and Day 15.
- Necropsy: All animals were euthanised on Day 15 - Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no unscheduled deaths at both 300 mg/kg and 2000 mg/kg dose levels.
- Clinical signs:
- other: There were no clinical signs of reaction to treatment in any animal thoughout the study period.
- Gross pathology:
- Dark discolouring to lung lobes were found in two animals dosed at 2000 mg/kg. As this finding is occationally noted in rats of this strain at these laboratories, it is regarded as a background finding and not a result of treatment. No other abnormalities were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the median lethal dose level (LD50) of EXP0700332 in Sprague-Dawley rats was considered to exceed 2000 mg/kg.
This study is considered to be relevant, reliable and adequate for risk assessment and for classification purposes. - Executive summary:
The objective of this OECD 423 study was to assess the adverse effects of EXP0700332 after a single oral gavage administration to Sprague-Dawley rats. The test item was administered to three groups of rats, comprising of three females, with one group being tested at 300 mg/kg and the two remaining groups being tested at 2000 mg/kg. The dose volume was based on the density and purity of the test item, and the individual doses were based on the individual body weight of the animals on the day of dosing. The animals were observed daily for 14 days after dosing and their body weights recorded before dosing and on Days 8 and 15. The following parameters and endpoints were evaluated in this study: clinical signs, body weights, body weight changes and gross necropsy findings.
All animals survived the treatment with no adverse clinical signs or macroscopic findings recorded for any animal. Body weight gains were considered to be acceptable for rats of this age and strain. The median lethal dose level (LD50) of EXP0700332 in Sprague-Dawely rats was considered to be in excess of 2000 mg/kg.
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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