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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
see box "Principles of method if other than guideline"
Principles of method if other than guideline:
Dose ranges are not given relative to body weight but in ppm.
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
TEST MATERIAL
- Name: Propyl gallate
- CAS no.: 121-79-9
- Batch: 2185
- Appearance: white, odorless powder, slightly bitter taste
- Purity: >98%
- Source: Harshaw Chemical Co. (Philadelphia, PA)
- Storage: dark, 5°C

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Frederick Cancer Research Center (Frederick MD)
- Number of animals per group: 5 female & 5 male
- Age at start of treatment: approx. 5 weeks
- Acclimatization: 8 days
- Housing: stainless steel cages, Hahn Roofing & Steel Metal Co. (Birmingham, AL); cages changed twice weekly
- Animals per cage: 5
- Diet: ad libitum, Wayne Lab Blox, Allied Mills inc., Chicago, IL
- Water: automatic watering system, Edstorm Industries (Waterford, WI)

ENVIRONMENTAL CONDITIONS
- Temperature: 21 - 23°C
- Humidity (%): (relative) 40 - 60%
- Photoperiod (hrs dark / hrs light): 12/12
- Air changes per hour: 15

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
ethanol
Details on oral exposure:
Weighed amount of propyl gallate and a solution of 20% ethanol in distilled water with a plunger attached to a high-speed drill until a suspension was obtained.
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: 14 days

OBSERVATION
- Weighing: at start of study, then weekly
- Mortality/Viability: there was five death out of five female & male animales in the 100,000 ppm and one male death out of five in the 50,000 ppm dose range.
- Clinical signs: twice daily for mortality
- Necropsy of survivors performed: yes, all animals were sacrificed

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 1 000 - < 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:
Survivors in 2000 mg/kg bw group were slightly inactive for 1 day after dosing.

Any other information on results incl. tables

One of five male and 3/5 female mice receiving 2,000 mg/kg body weight propyl gallate died within 2 hours of dosing; the survivors in this group were slightly inactive for 1 day after dosing. No death ocured among the 125, 250, 500, or 1,000 mg/kg bw groups, and no other compound-related effects were observed.

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.