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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
Study period:
From September 30, 1980 to March 17, 1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the equivalent of standard guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Method: 40 CFR Part 163.81-1 (Environmental Protection Agency Pesticide Programs. Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation: Humans and Domestic Animals. Acute Oral Toxicity Study)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
2-Propenoic acid, reaction products with pentaerythritol
EC Number:
629-850-6
Cas Number:
1245638-61-2
Molecular formula:
Not available for this UVCB.
IUPAC Name:
2-Propenoic acid, reaction products with pentaerythritol
Details on test material:
Name of test material (as cited in study report): SN-2196, C-171, JAB 318-80
Physical state: Viscous, clear liquid
Density: 1.1788 g/mL
Storage condition of test material: Stored at room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: Young adults
- Weight at study initiation: Males: 247-335 g and females: 213-254 g
- Fasting period before study: Overnight
- Housing: Six animals/cage in suspended, stainless steel with wire-mesh bottoms
- Diet (e.g. ad libitum): Purina Laboratory Rodent Diet, ad libitum
- Water (e.g. ad libitum): Municipal water, ad libitum
- Acclimation period: 14-28 d


ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64-78 °F
- Photoperiod (h dark / h light): 12 h dark / 12 h light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 1 % methylcellulose
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 0.04 - 4.2 mL/kg
Doses:
Range-finding test: 50, 100, 500, 1,000, 2,000 or 5,000 mg/kg bw
LD50 determination: 250, 350, 500, 700, 1,000, 1,400 or 2,000 mg/kg bw
No. of animals per sex per dose:
Range-finding screen: 5/sex (at 5,000 mg/kg bw); one/sex/dose (at other doses)
LD50 determination: 5/sex/dose
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations: Pharmacological and toxicological signs were observed approximately 1, 2, and 4 h after dosing and daily thereafter for 14 d; weighing done at pre-fast, post-fast (just prior to dosing), day 7 and 14 or at terminal sacrifice
- Necropsy of survivors performed: Yes; surviving animals were killed by carbon dioxide inhalation
Statistics:
Mortality data were analyzed by probit analysis method.

Results and discussion

Preliminary study:
Not applicable
Effect levelsopen allclose all
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
620 mg/kg bw
95% CL:
> 480 - < 760
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
420 mg/kg bw
95% CL:
> 340 - < 500
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
540 mg/kg bw
95% CL:
> 440 - < 640
Mortality:
Range-finding agent:
- 0/2, 0/2, 0/1, 1/2, 2/2 and 10/10 animals died at 50, 100, 500, 1,000, 2,000 and 5,000 mg/kg bw, respectively
LD50 determination test:
- 0/9, 2/10, 4/10, 9/10, 8/9, 10/10 and 8/8 animals died at 250, 350, 500, 700, 1,000, 1,400 and 2,000 mg/kg, respectively
Clinical signs:
other: - Decreased activity, dyspnea, soft stool, fecal staining, oral discharge, hypopnea and rales were observed at all dose levels - No unusual clinical signs were observed in the surviving animals
Gross pathology:
Examinations of animals which died revealed a variety of changes, primarily in the lungs and gastrointestinal tract; most of these were considered to represent post-mortem changes.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
Under the conditions of the study, the acute oral LD50 of the substance in male and female rats was calculated to be 620 (480-760) and 420 (340-500) mg/kg bw. The combined LD50 for male/female rats was calculated to be 540 (440-640) mg/kg bw.
Executive summary:

A study was conducted to assess the single dose toxicity of C-171 in Sprague-Dawley rats using a method equivalent or similar to OECD Guideline 401. 

Groups of 10 Sprague-Dawley rats (5/sex/dose) received a single oral (gavage) dose of 250, 350, 500, 700, 1,000, 1,400 or 2,000 mg/kg bw. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 day observation period.

Mortality was 0/9 at 250 mg/kg bw, 2/10 at 350 mg/kg bw, 4/10 at 500 mg/kg bw, 9/10 at 700 mg/kg bw, 8/9 at 1,000 mg/kg bw, 10/10 at 1,400 mg/kg bw and 8/8 at 2,000 mg/kg bw. All surviving animals showed gains in body weight between Days 7-14. Necropsy of animals which died prior to termination revealed a variety of changes, primarily in the lungs and gastrointestinal tract, most of which were considered to represent post-mortem changes.

Clinical signs noted at all dose levels were decreased activity, dyspnea, soft stool, fecal staining, oral discharge, hypopnea and rales. No unusual clinical signs were observed in the surviving animals.

In conclusion, under the conditions of the study, the acute oral LD50 of the substance in male/female rats was calculated to be 620 (480 -760) and 420 (340 -500) mg/kg bw. The combined LD50 for male/female rats was calculated to be 540 (440 -640) mg/kg bw.