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EC number: 807-489-7 | CAS number: 1447712-18-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2015-03-24 to 2015-04-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 2001-12-17
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-methyl-5-propylcyclohex-2-en-1-one
- EC Number:
- 807-489-7
- Cas Number:
- 1447712-18-6
- Molecular formula:
- C10H16O1
- IUPAC Name:
- 2-methyl-5-propylcyclohex-2-en-1-one
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: colourless to light yellow, clear liquid
- Storage condition of test material: room temperature (measurement value: 20.8 to 22.2°C, permissible range: 15 to 25°C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Crl:CD(SD)
- Source: ORIENTBIO INC., Korea
- Age: 8 week old
- Weight: 173.6 to 189.5 g
- Fasting period before study: animals were fasted overnight, approximately 16 hours prior to dosing. feed was provided approximately 4 hours post dosing.
- Housing: stainless wire mesh cage (260W x 350D x 210H (mm)); one animal/cage
- Diet (ad libitum, except for a fasting period before the study as described above): pelleted rodent chow (Teklad Certified Irradiated Global 18% Portein Rodent Diet 2918C; Harlan Laboratories, Inc., U.S.A.))
- Water (ad libitum): public tap water in Cheongju-si was filtered and irradiated by ultraviolet light
- Quarantine/Acclimation period: 3 day / 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21.0 to 23.8°C
- Relative humidity: 42.2 to 64.8%
- Air changes: 10 to 15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Lot no.: MKBP7039V
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw
Individual doses were calculated based on the animals' body weight recorded just prior to dosing.
DOSAGE PREPARATION:
The required amount of the test substance was weighed on an electronic balance and placed in a bottle. A small amount of vehicle was added and mixed using a vortex mixer until dissolved. The vehicle was gradually added to yield the desired concentration (400 mg/mL). All preparations were conducted just prior to use.
CLASS METHOD
- Rationale for the selection of the starting dose: due to the low expected toxicity of the test substance, based on information supplied by the sponsor, 2000 mg/kg bw was selected as the starting dose for this study. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female rats (3 female rats per dosing step)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: all animals were observed at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days.
Body weights were recorded prior to dosing (Day 0), on Days 1, 3 and 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes, all surviving animales were sacrificed on day 14. Complete gross postmortem examinations were performed on all animals. - Statistics:
- not applicable
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: LD50 cut-off value based on the flow chart according to the OECD guideline 423 .
- Mortality:
- All animals dosed at 2000 mg/kg survived the duration of the study.
- Clinical signs:
- other: Lacrimation and/or salivation were evident in five animals on the day of dosing. Mucous stool and/or soiled perineal region were observed in 3 animals on Day 1, but they returned to a normal appearance on Day 2. One rat presented clinical signs and those
- Gross pathology:
- No grossly visible evidence of morphologic abnormalities was evident in any animals.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 cut-off value (female rats) ≥ 5000 mg/kg bw
According to the Directive 67/548/EEC and its subsequent amendments, the test substance is not acutely toxic via the oral route.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not acutely toxic via the oral route. - Executive summary:
The acute oral toxicity of the test substance was investigated according to the OECD guideline 423 (2001). Two dose groups of three females received a single dose of 2000 mg/kg bw in corn oil via gavage. Clinical signs, mortality, and body weight were recorded. All animals were subjected to gross necropsy.
No mortality was observed during the study. Lacrimation and/or salivation were evident in five animals on the day of dosing. Mucous stool and/or soiled perineal region were observed in 3 animals on Day 1, but they returned to a normal appearance on Day 2. One rat presented clinical signs and those were decreased fecal volume or no stool from Day 1 to Day 3, refusal to feed on Day 2 only, decrease in locomotor activity and irregular respiration from Day 2 until Day 4, but all clinical signs returned to normal from Day 5 onwards. These clinical signs were considered to be test substance-related effects. Furthermore, a decrease in body weight or a tendency to suppress body weight was evident in five animals on Day 1 and Day 3. The five animals retunred to normal appearance on Day 7. These changes were considered to be test substance-related effects. Lastly, no grossly visible evidence of morphologic abnormalities was evident in any animals.
Based on these results the LD50 cut-off value was considered to be equal or greater than 5000 mg/kg bw for female rats.
According to the Directive 67/548/EEC and its subsequent amendments, the test substance is not acutely toxic via the oral route.
According to the Regulation (EC) No 1272/2008 and subsequent regulations, the test item is not acutely toxic via the oral route.
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