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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://www.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:
- 19th July - 2nd August 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- New Eporva 800
- IUPAC Name:
- New Eporva 800
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): New Eporva 800
- Physical state: Orange coloured liquid
- Analytical purity: 40%
- Batch No.: 504008
- Expiration date of the lot/batch: 31 October 1995
- Storage condition of test material: Room temperature in dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd, Bicester, Oxon, England
- Age at study initiation: approximately 4 to 7 weeks
- Weight at study initiation: 97 to 114 g
- Fasting period before study: overnight prior to and approximately 4 hours after dosing
- Housing: Housed in groups of up to 5 rats of the same sex in metal cages with win mesh floors
- Diet (e.g. ad libitum): standard laboratory rodent diet (SDS LAD 1) ad libitum
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): Relative humidity was not controlled but was anticipated to be in the range 30-70% RH
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light (0700 - 1900 hours) in each 24-hour period
IN-LIFE DATES: From: To: 19 July and 2 August 1995
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The dose level was chosen in compliance with the guideline. - Doses:
- 2.0 g/kg bodyweight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Mortality: Checked at least twice daily for any mortalities
- Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of six hours). Thereafter animals were observed twice daily (with the exception of Day 15- morning only).
- Bodyweight: The bodyweight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination
Results and discussion
- Preliminary study:
- No prelimunary study undertaken.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Piloerection was observed in all rats within five minutes of dosing, accompanied at this time by increased salivation in two males only. In addition, hunched posture, waddling gait and pallor of the extremities were seen in all rats at later intervals on
- Gross pathology:
- Macroscopic examination on Day 15 revealed no abnormalities.
Any other information on results incl. tables
A study was performed to assess the acute oral toxicity of New Eporva 800 to the rat.
A
group of ten fasted rats (five males and five females) was given a
single dose by oral gavage of the test substance, as supplied, at a dose
level of 2.0 g/kg bodyweight. All animals were killed and examined
macroscopically on Day 15, the end of the observation period.
There
were no deaths. Clinical signs of reaction to pregnant were confined to
piloerection, hunched posture, waddling gait, and pallor of the
extremities, seen in all rats with increased salivation seen in two
males only. Recovery was complete in all instances by Day 4.
All
rats achieved satisfactory bodyweight gains throughout the study.
Macroscopic
examination on Day 15 revealed no abnormalities.
The acute lethal oral dose to rats of New Eporva 800 was found to be greater than 2.0 g/kg bodyweight.
According to GHS criteria, New Eporva 800 should be classified as “category 5” or “not classified” with regard to acute oral toxicity.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute lethal oral dose to rats of New Eporva 800 was found to be greater than 2.0 g/kg bodyweight.
According to GHS criteria, New Eporva 800 should be classified as “category 5” or “not classified” with regard to acute oral toxicity.
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