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EC number: 202-228-8 | CAS number: 93-20-9
- 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant with current guidelines and GLP compliant
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(2-naphthyloxy)ethanol
- EC Number:
- 202-228-8
- EC Name:
- 2-(2-naphthyloxy)ethanol
- Cas Number:
- 93-20-9
- Molecular formula:
- C12H12O2
- IUPAC Name:
- 2-(2-naphthyloxy)ethanol
- Details on test material:
- - Name of test material (as cited in study report): EC 202-228-8
- Physical state: Solid
- Analytical purity: 98.5%
- Composition of test material, percentage of components: 2-(2-naphthoxy)ethanol >98.5%; Ethylene Carbonate < 0.5%; 2-Naphthol <0.5%; Ethylene Glycol < 0.5%
- Lot/batch No.: E00173-186
- Expiration date of the lot/batch: Jul 2013
- Storage condition of test material: Room Temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, NY
- Age at study initiation: The female rats were approximately 66 days of age at arrival at the Testing Facility.
- Weight at study initiation: The body weight range was 202 g to 226 g on the day after arrival at the Testing Facility.
- Fasting period before study: Rats were fasted overnight prior to dose administration through 3 to 4 hours postdose administration.
- Housing: The rats were individually housed in stainless steel, wire-bottomed cages.
- Diet (e.g. ad libitum): Ad libitum (except prior to dose administration)
- Water (e.g. ad libitum) Ad libitum:
- Acclimation period: The rats were acclimated for 5 days prior to assignment to study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Room temperature was targeted at 66°F to 77°F (19°C to 25°C).
- Humidity (%): The relative humidity was targeted at 30% to 70%.
- Air changes (per hr): The study rooms were maintained under conditions of positive airflow relative to a hallway and independently supplied with a minimum of 10 changes per hour of 100% fresh air that had been passed through 99.97% HEPA filters.
- Photoperiod (hrs dark / hrs light): An automatically controlled 12-hours light: 12-hours dark fluorescent light cycle was maintained.
IN-LIFE DATES: From: To: Dosing was initiated on 29 Aug 2011 and the in-life phase of the study was completed on 26 Sep 2011
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 60 and 400 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg
- Justification for choice of vehicle: This is a common vehicle for this type of substance.
- Lot/batch no. (if required): M-631
- Purity: 100%
DOSAGE PREPARATION (if unusual): A standard procedure was used to prepare the test material.
CLASS METHOD (if applicable) Annex 2c
- Rationale for the selection of the starting dose: It was presumed that test material of this type would not be extremely toxic. - Doses:
- The doses used on study were 300 and 2000 mg/kg.
- No. of animals per sex per dose:
- Six female rats were used at the 300 mg/kg dose level and six female rats were used at the 2000 mg/kg dose level.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The female rats were observed and a body weight was recorded on a daily basis.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food consumption and necropsy observations - Statistics:
- Averages and percentages were calculated for this study.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All female rats assigned to study survived until scheduled euthanasia.
- Clinical signs:
- other: Clinical observations observed considered test substance-related included: hunched posture was observed in one rat at 300 mg/kg; decreased motor activity, bradypnea, slight excess salivation, ptosis, ataxia and lacrimation were observed at 300 and 2000 m
- Gross pathology:
- No gross lesions were identified at necropsy.
Any other information on results incl. tables
Absolute (g/day) and relative (mg/kg/day) food consumption values were reduced in the 2000 mg/kg dose groups, as compared with values for the rats in the 300 mg/kg dose groups on DSs 1 to 2, 2 to 3 and 3 to 4. A comparable rebound in absolute food consumption values was observed in both 2000 mg/kg dose groups on DSs 4 to 5 and the absolute and relative food consumption values remained generally comparable for the remainder of the study including the entire study period (calculated as DSs 1 to 14). The mean absolute food consumption value for the rats in the 2000 mg/kg dose groups (averages of Groups 1 and 2) were reduced by 12% for the first week after dose administration (calculated as DSs 1 to 8), as compared with the mean value for the rats in the 300 mg/kg dose groups (average of Groups 3 and 4).
The mean relative food consumption value for the rats in the 2000 mg/kg dose groups (averages of Groups 1 and 2) were reduced by 19% for the first week after dose administration (calculated as DSs 1 to 8), as compared with the mean value for the rats in the 300 mg/kg dose groups (average of Groups 3 and 4). Absolute and relative food consumption values were generally comparable between the 300 and 2000 mg/kg dose groups during the second week of the study (calculated as DSs 8 to 14).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information No mortality was caused at 2000 mg/kg; however, there were adverse clinical signs, body weight loss and decreased food consumption at this dose. Criteria used for interpretation of results: EU
- Conclusions:
- CONCLUSION
In conclusion, administration of a single dose of 300 or 2000 mg/kg of test substance did not cause mortality. Doses of 300 and 2000 mg/kg produced adverse clinical signs that were apparent at the 30 minute postdose observation but were no longer apparent by the end of the day postdose observation. The 2000 mg/kg dose reduced body weight and food consumption the first several days after dose administration. - Executive summary:
Executive Summary
The objectives of this study were to determine the acute toxicity resulting from exposure to EC 202-228-8 (test substance) in Crl:CD(SD) rats, and to estimate the defined exposure ranges where lethality is expected, since death of a proportion of the animals was a major endpoint of this study.
The study design was as follows:
Text Table1
Experimental DesignExposure Group No.
No. of Female Rats
Test Material
Dose Level
(mg/kg)a,b
Concentration
(mg/mL)
Dose Volume
(mL/kg)
1
3
Test Substance
300
60
5
2
3
Test Substance
300
60
5
3
3
Test Substance
2000
400
5
4
3
Test Substance
2000
400
5
a Subsequent dose levels were established by the Study Director based on the results of the initial 300 mg/kg dose.
b Rats were fasted overnight prior to dose administration through 3 to 4 hours after dose administration.
Female rats were administered the test substance once by oral gavage. The rats were fasted overnight prior to dose administration through 3 to 4 hours postdose administration. Doses were adjusted for fasted body weights taken before administration. The first day of dose administration was designated as Day 1 of study (DS 1) for each rat.
The 300 mg/kg dose level was administered to 3 female rats. No mortality and body weight gain were observed; therefore, an additional 3 female rats were dosed once with 300 mg/kg of test substance. No mortality and body weight gain were observed following dose administration; therefore, an additional 3 female rats were dosed once with 2000 mg/kg of test substance. No mortality was observed following dose administration; therefore, an additional 3 female rats were dosed once with 2000 mg/kg of test substance. All doses were based on a 5 mL/kg dose volume.
The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight changes, food consumption, and gross necropsy findings.
Clinical observations observed considered test substance-related included hunched posture, decreased motor activity, bradypnea, slight excess salivation, ptosis, ataxia, lacrimation, impaired righting reflex, low carriage and coldness to the touch. The adverse clinical observations were first observed at approximately 30 minutes postdose. These clinical observations persisted for approximately two hours in the 300 mg/kg dose groups and until the end of day post-checks in the 2000 mg/kg dose groups. All rats appeared normal on DS 2 and continued to be normal for the remainder of the study.
Body weight gains were reduced in the 2000 mg/kg dose groups, as compared with values for the rats in the 300 mg/kg dose groups on DSs 1 to 2. A body weight loss was observed in the 2000 mg/kg dose groups on DSs 2 to 3. A comparable rebound in body weight gain was observed in both 2000 mg/kg dose groups on DSs 4 to 5.
Absolute and relative food consumption values were reduced in the 2000 mg/kg dose groups, as compared with values for the rats in the 300 mg/kg dose groups on DSs 1 to 2, 2 to 3 and 3 to 4. A comparable rebound in absolute food consumption values was observed in both 2000 mg/kg dose groups on DSs 4 to 5 and the absolute and relative food consumption values remained generally comparable for the remainder of the study.
No gross lesions were identified at necropsy.
In conclusion, administration of a single dose of 300 or 2000 mg/kg of test substance did not cause mortality. Doses of 300 and 2000 mg/kg produced adverse clinical signs that were apparent at the 30 minute postdose observation, but were no longer apparent by the end of the day postdose observation. The 2000 mg/kg dose reduced body weight and food consumption the first several days after dose administration.
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