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EC number: 202-594-9 | CAS number: 97-61-0
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Documentation insufficient. Screening test method (range-finding study for developmental toxicity study). Low animal numbers; limited pathology in dams and pups. Acceptable for gross estimation of toxic doses and effects.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Principles of method if other than guideline:
- Method: Range-finding study for performance of a developmental study: 3 or 6 animals per test group were used.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-methylvaleric acid
- EC Number:
- 202-594-9
- EC Name:
- 2-methylvaleric acid
- Cas Number:
- 97-61-0
- Molecular formula:
- C6H12O2
- IUPAC Name:
- 2-methylpentanoic acid
- Details on test material:
- 2-Methylpentanoic acid [CAS No. 97-61-0], not further specified, commercial, from Chem. Dynamics Corp.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charle sRiver, Raleigh, NC, USA
- Weight at study initiation: 240 - 310 g
- Fasting period before study: no data
- Housing: singly in polycarbonate cages
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 50 +/- 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 2 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 10 d
- Frequency of treatment:
- 1x/d
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150, 300, 600, 900, and 1200 mg/(kg*d) in corn oil (2 ml/kg)
Basis:
- No. of animals per sex per dose:
- Three to nine
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Post-exposure period: 5 d
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: study days 1, 3, 5, 8, 11, and 15
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: No
HISTOPATHOLOGY: No
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- rales (all treated animals), dyspnea (dose-related at 300 mg/kg and above); motor depression in 2/3 animals at 1200 mg/kg. Mortality: 0% at 150 and 300 mg/kg; 67/100/100% at 600/900/1200 mg/kg and day. Deaths occurred within the first 5 days of treatment.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- rales (all treated animals), dyspnea (dose-related at 300 mg/kg and above); motor depression in 2/3 animals at 1200 mg/kg. Mortality: 0% at 150 and 300 mg/kg; 67/100/100% at 600/900/1200 mg/kg and day. Deaths occurred within the first 5 days of treatment.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Psot mortem findings included gas in the GI tract; smal spleen, dark red foci on the gastric mucosa
Effect levels
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Clinical
signs of intoxication: respiratory distress in all animals (primarily
rales, followed by dyspnea). Ataxia or decreased motor activity
at 900 and 1200 mg/kg.
Body weight loss: significant at 300 and higher after 6 and 4 d.
Mortality: none at 150 and 300 mg/kg, 2/3 and 3/3 at 600 and both upper doses,
resp.; all within the first 5 d of treatment, mostly after the 2nd dose.
Autopsy revealed dark-red foci on gastric mucosa, small spleen, and gas accumulation
in the gastro-intestinal tract.
No clear NOAEL can be derived due to clinical symptoms already seen at the
lowest dose.
Applicant's summary and conclusion
- Conclusions:
- Invalid study; range-finder
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