Registration Dossier

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:
2014
Report Date:
2014

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF 12 Nousan No 8147, 2000
Deviations:
no
GLP compliance:
yes (incl. certificate)
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
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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

Test animals

Species:
rat
Strain:
other: Sprague Dawley Crl:CD (SD)
Sex:
female
Details on test animals 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