1,3-dimethyl-3-phenylbutyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 May 2017 to 7 June 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

Adopted 17th December 2001

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 3

Qualifier:

equivalent or similar to guideline

Guideline:

other: "Regulation on Test Methods for Chemical Substances" Notification No. 2017-4, National Institute of Environmental Research, Republic of Korea (Mar. 14, 2017)

Deviations:

not specified

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,3-dimethyl-3-phenylbutyl acetate

EC Number:

268-407-8

EC Name:

1,3-dimethyl-3-phenylbutyl acetate

Cas Number:

68083-58-9

Molecular formula:

C14H20O2

IUPAC Name:

4-methyl-4-phenylpentan-2-yl acetate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: ORIENTBIO INC., Republic of Korea
- Age at study initiation: 8 weeks
- Weight at study initiation: 183.0-185.1 g
- Fasting period before study: yes, animals were fasted overnight, approximately 16 hours prior to dosing
- Housing: one animal/ cage
- Diet (e.g. ad libitum): Pelleted rodent chow, ad libitum
- Water (e.g. ad libitum): Public tap water in Cheongju-si was filtered and irradiated by ultraviolet light and provided ad libitum.
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1−23.2°C (Measured value)
- Humidity (%): 43.7 - 53.9 % (Measured value)
- Air changes (per hr): 10−15 clean, fresh, filtered air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle, 150 - 300 Lux

IN-LIFE DATES: From: To: 16 May - 2 June 2017

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 400 mg/mL

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg body weight

- Rationale for the selection of the starting dose: The starting dose of 2,000 mg/kg was selected due to the low expected toxicity of the test item.

Doses:

2000 mg/kg

No. of animals per sex per dose:

2 groups of 3 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for mortality, general condition and clinical signs at 30 minutes after dosing and at 1, 2, 4 and 6 hours after dosing on Day 0 and once daily thereafter for 14 days (Day 1−Day 14). The body weight was recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: complete gross postmortem examinations

Statistics:

Statistical analysis was not performed. Mean scores and values were determined.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities observed at 2000 mg/kg.

Clinical signs:

other: Abnormal gait was observed in 2−4 animals at 2000 mg/kg at 2−6 hours after dosing, and mucous stool was observed in all animals on Day 1. These signs disappeared on Day 2.

Gross pathology:

No grossly visible findings were observed.

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The test item was classified as Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg b.w.

Executive summary:

The toxicity of test item following a single oral dose administration to female Sprague-Dawley rats was tested according to OECD 423 and EU B.1 tris guidelines.

All animals were monitored for clinical signs and body weight changes during the 14-day observation period after administration and a gross necropsy was performed at the end of the observation period.

There were no deaths of animals at 2000 mg/kg. Abnormal gait was observed in animals at 2000 mg/kg on the day of dosing and mucous stool was observed on Day 1. And they disappeared on Day 2. No test substance-related effects were observed in body weight data or necropsy findings in any animal at 2000 mg/kg. The test item was classified as Category 5 or Unclassified according to the GHS classification and the median lethal dose derived was: LD50 cut off ≥ 5,000 mg/kg b.w.