Propyl 3,4,5-trihydroxybenzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

- Principle of test: Single-dose study as a pre-test of a carcinogenesis bioassay
- Short description of test conditions: Groups of five mice of each sex were given a single dose of propyl gallate (125, 250, 500, 1000 and 2000 mg/kg) in 20% ethanol in water by gavage. No controls were used.
- Parameters analysed / observed: Animals were observed twice daily for mortality during a 15-day test period.

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propyl 3,4,5-trihydroxybenzoate

EC Number:

204-498-2

EC Name:

Propyl 3,4,5-trihydroxybenzoate

Cas Number:

121-79-9

Molecular formula:

C10H12O5

IUPAC Name:

propyl 3,4,5-trihydroxybenzoate

Specific details on test material used for the study:

TEST MATERIAL
- Name: propyl gallate
- CAS no.: 121-79-9
- Appearance: white, odorless powder, slightly bitter taste
- Purity: >99%

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Source: Harshaw Chemical Co., Philadelphia, PA; lot No.: 2185

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at 5 °C

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Frederick Cancer Research Center, Frederick, MD
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: 5 weeks
- Weight at study initiation: not specified
- Fasting period before study: not specified
- Housing: Animals were housed in stainless steel cages (Hahn Roofing & Sheet Metal Co., Birmingham, AL); 5 animals per cage
- Diet (e.g. ad libitum): ad libitum, Wayne Lab Blox Allied Mills, Inc. Chicago, IL
- Water (e.g. ad libitum): ad libitum, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Relative humidity (%): 38-42
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 9 hours of fluorescent light per day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

ethanol

Details on oral exposure:

Propyl gallate was prepared in 20% ethanol in distilled water. Each animal received 10 mL/kg bw.

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Purity: 20% ethanol in water

MAXIMUM DOSE VOLUME APPLIED: 10 mL/ kg body weight

DOSAGE PREPARATION (if unusual): Propyl gallate was weighed and a solution of 20% ethanol in distilled water were mixed with a plunger attached to a high-speed drill until a suspension was obtained (mixing time was not recorded).

Doses:

125, 250, 500, 1000, or 2000 mg/kg body weight

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations: Animals were observed twice daily for mortality and morbidity
- Necropsy of survivors performed: no

Statistics:

n.a.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1/5 male and 3/5 female mice receiving 2000 mg/kg bw propyl gallate died within 2 hours of dosing.

Clinical signs:

other: Survivors in 2000 mg/kg bw group were slightly inactive for 1 day after dosing.

Gross pathology:

Not examined

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

One of five male and 3 of 5 female mice receiving 2000 mg/kg body weight propyl gallate died within 2 hours of dosing. The surviving animals in this group were slightly inactive for 1 day after dosing. No death occurred among the 125, 250, 500 or 1000 mg/kg bw dose groups. No other compound-related effects were observed.

Executive summary:

In a single dose acute toxicity study conducted similar to OECD Guideline 401, 5 male and 5 female mice received 125, 250, 500, 1000, or 2000 mg/kg body weight propyl gallate (98% purity).

The animals were observed for a total of 14 days. One of five male and 3 of 5 female mice receiving 2000 mg/kg body weight propyl gallate died within 2 hours of dosing. The surviving animals in this group were slightly inactive for 1 day after dosing. No death occurred among the 125, 250, 500, or 1000 mg/kg bw dose groups. Moreover, no other compound-related effects were observed. Based on the results, the LD₅₀ can be considered to be greater than 1000, but lower than 2000 mg/kg bw in female mice.