Phenethyl benzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

October 2002 - October 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Data is from study report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 16 CFR 1500.40

Deviations:

not specified

Principles of method if other than guideline:

The purpose of this study was to assess the Toxicological profile of test item to a single administration via dermal route to rabbits.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Phenethyl benzoate

EC Number:

202-336-5

EC Name:

Phenethyl benzoate

Cas Number:

94-47-3

Molecular formula:

C15H14O2

IUPAC Name:

2-phenylethyl benzoate

Test material form:

liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: A single dose of the test article was applied to the prepared site, under a 4 ply porous gauze dressing measuring 10 x 15 cm
- Type of wrap if used: The torso was wrapped with plastic which was secured with non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The sites were wiped (not washed) prior to making dermal evaluations.
- Time after start of exposure:24 hours

TEST MATERIAL
- Concentration (if solution): The dose was based on the sample weight as calculated from the specific gravity.

Duration of exposure:

24 hrs

Doses:

2000 mg/kg b.w.

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal responses were recorded 24 hours postdose and on days 7 and 14. Animals were observed for mortality, toxicity and pharmacological effects once daily for 14 days. Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time.
- Necropsy of survivors performed: yes, All animals were humanely sacrificed using CO2 following study termination.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived at the 2000 mg/kg dermal application.

Clinical signs:

other: Dermal responses were absent to slight at 24 hours and absent on days 7 and 14. There were no abnormal physical signs noted during the observation period.

Gross pathology:

Not examined

Any other information on results incl. tables

Dose level: 2000 mg/kg bw

Time periods	G1965 M	G1966 M	G1967 M	G1968 M	G1969 M	G1994 F	G1995 F	G1996 F	G1997 F	G1998 F
Day 0
Day 1
Day 2
Day 3
Day 4
Day 5
Day 6
Day 7
Day 8
Day 9
Day 10
Day 11
Day 12
Day 13
Day 14

No entry indicates animal appeared normal at that observation period.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified

Conclusions:

The lethal concentration (LD50) value for acute dermal toxicity test was considered to be >2000 mg/kg bw, when male and female New Zealand White rabbits were treated with test chemical to the dermal application semiocclusively according to 16 CFR 1500.40.

Executive summary:

The acute dermal toxicity profile of the given test chemical was conducted according to 16 CFR 1500.40 in male and female New Zealand White rabbits.

A single dose of the test chemical was applied to the prepared site, under a 4 ply porous gauze dressing measuring 10 x 15 cm at a dose level of 2000 mg/kg. The dose was based on the sample weight as calculated from the specific gravity. Gentle pressure was applied to the gauze to aid in the distribution of the test substance over the prepared site. The torso was wrapped with plastic which was secured with non-irritating tape. The test chemical remained in contact with the skin for 24 hours at which time the wrappings were removed and an estimate of the amount of test article remaining was made. The sites were wiped (not washed) prior to making dermal evaluations.

Dermal responses were recorded 24 hours postdose and on days 7 and 14. Animals were observed for mortality, toxicity and pharmacological effects once daily for 14 days. Body weights were recorded pretest and at termination. The general health of the animals was monitored at each observation time. All animals were humanely sacrificed using CO2 following study termination.

All animals survived at the 2000 mg/kg dermal application. Dermal responses were absent to slight at 24 hours and absent on days 7 and 14. There were no abnormal physical signs noted during the observation period. Body weight changes were normal.

Under the condition of the study, the lethal concentration (LD50) value for acute dermal toxicity test was considered to be >2000 mg/kg bw, when male and female New Zealand White rabbits were treated with test chemical to the dermal application semiocclusively according to 16 CFR 1500.40.