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EC number: 403-610-9 | CAS number: 122795-41-9
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- between 18 May and 8 June 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 403-610-9
- EC Name:
- -
- Cas Number:
- 122795-41-9
- IUPAC Name:
- 1-ethyl-3-methoxytricyclo[2.2.1.0²,⁶]heptane; 2-ethyl-5-methoxybicyclo[2.2.1]heptane; 2-ethyl-6-methoxybicyclo[2.2.1]heptane
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD (SD) BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were in a weight range of 105 to 142 g prior to dosing and approximately four to six weeks of age. All the rats were acclimated to the experimental environment for a period of 7 days prior to the start of the main study.
The rats were allocated to cages within the treatment groups. They were housed in groups by sex in metal cages with wire mesh floors. A standard laboratory rodent diet (Labsure LAD 1) and water were provided ad libitum. The batch of diet used for the study was analysed for certain chemical and microbiological contaminants. Access to food only was prevented overnight prior to and approximately 4 hours after dosing.
The main daily minimum and maximum temperatures of the animal room were 20°C and 23°C respectively and the mean daily relative humidity value was 63%. The rate of air exchange was maintained at approximately 15 air changes/hour. Lighting was controlled by means of a time switch to provide 12 hours artificial light in each 24 hour period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- Dose Dose Volume
1) 1.26 g/kg, 1.33ml/kg
2) 2.00g/kg, 2.11ml/kg
3) 3.20g/kg, 3.37ml/kg - No. of animals per sex per dose:
- 5 females and 5 males per dose
- Control animals:
- no
- Details on study design:
- Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of five hours). On the subsequent days the animals were observed once in the morning and again at the end of the experimental day. Clinical signs were recorded at each observation.
Animals surviving treatment on the preliminary and main studies were observed for 5 and 14 days respectively, after dosing.
In the main study the following were recorded: approximate time of death of individual rats, nature, severity, approximate time of onset and duration of each toxic sign, individual bodyweights of rats on Days 1 (day of dosing), 8 and 15 and at death.
Surviving animals on the main study were killed on Day 15 by cervical dislocation. All animals died during the study and those killed on Day 15 were subjected to a macroscopic post mortem examination which consisted of opening the abdominal and thoracic cavities. The macroscopic appearance of abnormal organs when present was recorded. - Statistics:
- The acute median lethal oral dose to male and female rats was calculated using the method of Finney (1971) probit analysis (3rd Edition) Cambridge University Press. Separate LD50 values for males and females were estimated by undertaking probit analysis on the mortality data by fitting two parallel lines on the data (males only and females only) using the technique described by Finney. A chi-squared test was carried out to check that the data did not contain any evidence for non-parallelism.
Results and discussion
- Preliminary study:
- A trial test was carried out by dosing two male and two female rats at 2.50 g/kg bodyweight.
The results of the preliminary study indicated that the acute median lethal oral dose to male and female rats of ethyl methoxy norbornane was less than 2.50 g/kg bodyweight.
Further groups of ten rats (five males and five females) were dosed at 1.26, 2.00, and 3.20 g/kg in order to determine the acute toxicity of the test substance more precisely.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 100 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 700 - <= 2 700
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 300 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 700 - <= 3 300
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 300 - <= 2 700
- Mortality:
- There were deaths amngst rats of both sexes dosed at 2.00 g/kg and above. All deaths occurred on Day 2.
Autopsy of rats that died prior to scheduled termination revealed no macroscopic abnormalities.
Bodyweight losses (≤11g) were determined by comparison with Day 1 bodyweights for animals that died prior to the scheduled termination. - Clinical signs:
- other: Signs of reaction to treatment observed in all rats from within three hours of dosing were pilo-erection, abnormal body carriage (hunched posture), abnormal gait (waddling), lethargy, pallor of the extremities and increased salivation. These clinical resp
- Other findings:
- Terminal autopsy findings were normal.
Applicant's summary and conclusion
- Interpretation of results:
- other: not acute harmful according to EU CLP (EC 1272/2008 and its amendments)
- Conclusions:
- The acute median lethal oral dose (LD50) and their 95% confidence limits to rats of Neoproxen were calculated to be:
Males & female combined: 2.1 g/kg bodyweight (1.7-2.7)
Males only: 2.3 g/kg bodyweight (1.7-3.3)
Females only: 1.9 g/kg bodyweight (1.3-2.7) - Executive summary:
Using OECD TG 401, the acute median lethal oral dose (LD50) and their 95% confidence limits to rats of Neoproxen was 2.1 g/kg bodyweight (1.7 -2.7): males and females combined.
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