Registration Dossier
Registration Dossier
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EC number: 611-930-7 | CAS number: 60045-26-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01November 2013 to 29 November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study carried out to guideline requiremnets and in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: JMAFF 12 Nousan No 8147, 2000
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certificate of Compliance with GLP issued by UK GLP Monitoring Authority included in report
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 3-phenylpropyl benzoate
- EC Number:
- 611-930-7
- Cas Number:
- 60045-26-3
- Molecular formula:
- C16H16O2
- IUPAC Name:
- 3-phenylpropyl benzoate
- Reference substance name:
- Kalama® K-Flex® 613
- IUPAC Name:
- Kalama® K-Flex® 613
- Test material form:
- other: clear colourless liquid
- Details on test material:
- - Name of test material (as cited in study report): 3-Phylpropyl benzoate
- Physical state: clear, colourless liquid
- Analytical purity: 99.1%
- Lot/batch No.: EH101912A
- Expiration date of the lot/batch: 19 October 2014
- Storage condition of test material: Room temperature under Nitrogen
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Sprague Dawley Crl:CD (SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 226 - 240g
- Fasting period before study: overnight
- Housing: Group housing 3 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 -23 deg C
- Humidity (%): 40 - 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 07 November To: 29 November
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10mL/kg bodyweight
- Justification for choice of vehicle: none stated
- Lot/batch no. (if required):
- Purity:
MAXIMUM DOSE VOLUME APPLIED:
DOSAGE PREPARATION (if unusual):
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Doses:
- 2000 mg/animal
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequent observations on day of dosing and twice per day thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,other: macroscopic pathology of vranial, thoracic and abdominal cavities
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no deaths during study
- Clinical signs:
- Loose faeces in two females dosed at 2000 mg/kg. first noted 30 min after dosing and then not observed from end of Day 2 onwards
- Body weight:
- Bodyweight loss noted in one rat, all other rats achieved satisfactory bodyweight gain
- Gross pathology:
- NO abnormalities noted
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute median lethal dose (LD50) to rats of 3-Phenylpropyl benzoate was >2000 mg/kg bodyweight
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