Registration Dossier
Registration Dossier
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EC number: 407-770-0 | CAS number: 61597-96-4 D(+)-LACTATE D'ISOBUTYLE
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-methylpropyl-(R)-2-hydroxypropanoate
- EC Number:
- 407-770-0
- EC Name:
- 2-methylpropyl-(R)-2-hydroxypropanoate
- Cas Number:
- 61597-96-4
- Molecular formula:
- C7 H14 O3
- IUPAC Name:
- 2-methylpropyl-(R)-2-hydroxypropanoate
- Details on test material:
- - Name of test material (as cited in study report): D-Milchsaeureisobutylester
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, 7950 Biberach
- Weight at study initiation: mean: female: 181 g; male: 173 g
- Fasting period before study: 16 hours before application
- Housing: 5 per cage
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 50%
- Justification for choice of vehicle: aqueous solution correlates to physiologic solution
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw - Doses:
- 5000 mg/kg bw
- 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: once daily, weighing: on day 2, 7, and 13 after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- rattling breath 2 days after application in males and females
lacrimation 15 to 30 minutes after application in females and less than 15-30 minutes after application in males - Body weight:
- normal weight gain
- Gross pathology:
- organs without abnormalities
Applicant's summary and conclusion
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