4-methoxybenzyl alcohol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 October 2015 and 11 January 2016

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 (incl. QA statement)

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
- Source: Orientbio Inc., Republic of Korea
- Age at study initiation: 8 weeks old
- Weight at study initiation: 181.5 - 198.2 g
- Fasting period before study: yes, overnight
- Housing: individually (during the study)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2 - 23.4
- Humidity (%): 48.6 - 55.2
- Air changes (per hr): 10 - 15
- 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

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

CLASS METHOD
- Rationale for the selection of the starting dose: Due to expected low toxicity of the test substance, 2000 mg/kg was selected as the starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

6 (divided in two groups for step 1 and step 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: prior to dosing on day 0 and on days 1, 3, 7 and on the day of necropsy, day 14
- Frequency of observations (mortality, general conditions and clinical signs): at 30 min after dosing and at 1, 2, 4 and 6 hours after dosing on day 0 and once thereafter for 14 days (day 1 to day 14)
- Necropsy of survivors performed: yes (complete gross postmortem examinations were performed on all animals)

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:

none

Clinical signs:

Decrease of fecal volume was evident in one animal at 2000 mg/kg bw on day 1 after dosing, and then it normalized on day 2 afte 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 bw 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 at 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the acute oral toxicity study in rats, the LD (cut off) value was determined to be greater or equal than 5000 mg/kg bw.

Executive summary:

The acute oral toxicity of the test substance analogue was examined in a GLP-conform study according to OECD 423. A single oral dose of the test substance analogue was administered to two groups of three female Sprague-Dawley rats. In the first step, a dose 2000 mg/kg bw was administered to the first group and no mortality was observed. In the second step, the same dose was administered to group 2. All animals were monitored for clinical signs and body weight changes during 14 -day observation period after administration. They were subjected to a gross necropsy at the end of the observation period. There were no deaths of animals at 2000 mg/kg bw. Decrease of fecal volume was evident in one animal at 2000 mg/kg bw on day 1 after dosing, and then it normalized on day 3. No substance-related effects were evident in any animal at 2000 mg/kg bw. Based on the results of the acute oral toxicity study in rats, the LD (cut off) value was determined to be greater or equal than 5000 mg/kg bw.