Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
21 November 2013 to 11 December 2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to OECD guidelines 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:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1200 (Acute Dermal 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 from UK GLP Monitoring Authority included in report
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Phenylpropyl benzoate
-
- Substance type: organic
- 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
- Other:

Test animals

Species:
rat
Strain:
other: Crl:CD (SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: Males = 342 - 380g; Females = 234 - 255g
- Fasting period before study: none
- Housing: group housed in groups of 5 rats of same sex
- 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): 12h dark: 12 h light

IN-LIFE DATES: From: 21 November 2013 To: 11 December 2013

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 mm x 50 mm
- % coverage:
- Type of wrap if used: porous gauze covered with non-irritating dressing and then a waterproof dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water with dilute detergent
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.86 mL/kg
- Concentration (if solution):
- Constant volume or concentration used: yes
- For solids, paste formed: yes/no

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of exposure:
24 hours
Doses:
1.86 ml/kg body weight, specific gravity 1.077 g/ml
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days
- Frequency of observations and weighing: daily for any signs of reaction and mortalities, after dosing and frequently in Day 1, subsequently twice per day. Bodyweights on Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: body weights, macroscopic pathology of cranial, thoracic and abdominal cavities

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deathes
Clinical signs:
Very slight erythema was seen in all females from Day 3, resolving in all instances by Day 6. In addition, bandage reactions (off the treatment site) were seen in all females and two males from Day 2, generally resolving by Day 9, but persisting in one animal (No. E9) until termination on Day 15
Body weight:
All animals were considered to have achieved satisfactory body weight gains throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The acute median lethal dermal dose (LD50) to rats of 3-Phenylpropyl benzoate was demonstrated to be greater than 2000 mg/kg body weight.
Executive summary:

The acute median lethal dermal dose (LD50) to rats of 3-Phenylpropyl benzoate was demonstrated to be greater than 2000 mg/kg body weight.