p-methoxybenzyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2015-11-10 to 2015-12-14

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 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute 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:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male: 276.9 −294.0 g, female: 224.9 −246.8 g
- 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-062215MA , 2918C-080315MA, Harlan Laboratories, Inc., U.S.A.
- Water: ad libitum, public tap water in Cheongju-si was filtered and irradiated by ultraviolet light

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2−22.6
- Humidity (%): 47.7-57.6
- Air changes (per hr): 10−15, fresh, filtered
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: subscapular dorsal surface of back, 4 cm*5 cm
- Type of wrap if used: lint tape and plastic film, over-wrapped with Soft Cloth Tape with Liner and surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing: absorbent cotton moistened with tepid water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 1.81 mL/kg bw corresponding to 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 h

Doses:

1.81 mL/kg bw corresponding to 2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes, concurrent no treatment

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 to Day 14). The body weight was recorded recorded prior to dosing on Day 0 and on Days 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 performed using SAS Program (version 9.3, SAS Institute Inc., U.S.A.). Body weights were analyzed utilizing Folded-F test for homogeneity of variance (significance level: 0.05). Student t-test was employed on homogeneous data (significance levels: 0.05 and 0.01, two-tailed).

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:

No mortality was observed.

Clinical signs:

No clinical abnormalities was observed.

Body weight:

No statistical significant difference between control and treatment group was observed.

Gross pathology:

No grossly visible findings were evident in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 was determined to be greater than 2000 mg/kg bw in rats.

Executive summary:

An acute dermal toxicity study according to OECD 402 was conducted in rats. Test groups consisted of one dose group at a dose of 2000 mg/kg bw and a control group. Both groups consisted of 5 males and 5 females. All animals were monitored for clinical signs and body weight changes after dosing during the 14-day observation period. They were subjected to gross necropsy at the end of the observation period. All animals survived the duration of the study. No test substance-related effects were evident in clinical signs, body weight data or necropsy findings. Based on the results of this study, the LD50 value of the test substance was considered to be greater than 2000 mg/kg bw in male and female rats under the conditions of this study.