p-methoxybenzyl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-10-27 to 2015-11-30

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

p-methoxybenzyl acetate

EC Number:

203-185-8

EC Name:

p-methoxybenzyl acetate

Cas Number:

104-21-2

Molecular formula:

C10H12O3

IUPAC Name:

4-methoxybenzyl acetate

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 181.5−198.2 g
- Fasting period before study: overnight (16 h)
- Housing: Stainless wire mesh cage, 260W×350D×210H (mm), one animal/cage (during the study)
- Diet: ad libitum, Pelleted rodent chow (Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C), Lot: 2918C-051215MA, Harlan Laboratories, Inc., U.S.A.
- Water: ad libitum, public tap water in Cheongju-si was filtered and irradiated by ultraviolet light
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2−23.4
- Humidity (%): 48.6−55.2
- Air changes (per hr): 10−15, fresh, filtered
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 400 mg/mL
- Amount of vehicle: 5 mL/kg
- Lot/batch no.: MKBS6944V

CLASS METHOD
- Rationale for the selection of the starting dose: Due to expected low toxicity of the test substance and based on the information supplied by the sponsor, 2000 mg/kg was selected as the starting dose for this study.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6, all 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 h after dosing on Day 0 and once daily thereafter for 14 days (Day 1 to Day 14). The body weights were 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: clinical signs, body weight

Statistics:

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

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no effects on the mortality.

Clinical signs:

Decrease of fecal volume was evident in one animal at 2000 mg/kg on Day 1 after dosing, and then it normalized on Day 2 after dosing. Therefore, it was considered to be a test substance-related temporary change.

Body weight:

A tendency to suppressed body weight gain was evident in all animals at 2000 mg/kg on Day 1 after dosing. Then, these animals returned to be normal on Day 3. These changes were considered to be test substance-related effects.

Gross pathology:

No grossly visible evidence of morphological abnormalities was evident in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral toxicity study with 2000 mg/kg bw of the test substance caused no mortality in rats and therefore a LD0 of 2000 mg/kg bw and LD50 cut off >=5000 mg/kg bw were derived.

Executive summary:

In an orale acute toxicity study, six fasted Sprague-Dawley female rats, divided into two groups, were orally exposed once with the test substance at a concentration level of 2000 mg/kg bw and were observed for a period of 14 days (OECD 423). No deaths and abnormalities at necropsy were observed. Decrease of fecal volume was evident in one animal on Day 1, it normalized on Day 2. A tendency to suppressed body weight gain was evident in all animals at on Day 1. The body weight gain returned to be normal on Day 3 for all animals. The LD0 value of the test material was established to be 2000 mg/kg bw. The LD50cut off value of the test material was estimated to be greater than 5000 mg/kg bw.