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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
acceptable for assessment although with limited documentation
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Screening data pre-GLP and pre-guideline development, study details not reported in the publication.
Reason / purpose:
reference to same study
Principles of method if other than guideline:
pre-guideline development
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Sex:
not specified
Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
1810, 2720, 3630, 4540, 5440 and 7260 mg/kg/bw
No. of animals per sex per dose:
1 animal per dose
Statistics:
LD50-values calculated by the method of Bliss (1938).
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 720 mg/kg bw
Mortality:
 Single rabbits survived doses of 1.81, 2.72 and  4.54 gram/kg. Single rabbits died at doses of 3.63, 5.44 and 7.26 g/kg. 
Clinical signs:
Lethal doses produced a constant train of disturbances. The animals  showed an increased rate of respiration (with lacrymation in rats) in  about 2 to 5 minutes, followed by motor weakness and decreased  respiration in 15 - 40 minutes. Subsequently, respiration became shallow,  irregular and labored and there were increased 
defecation and urination.  Reflex activity was lost and the animals died in coma. The rats urine  usually contained blood but it was only occasionally found in the rabbits  urine.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1941

Materials and methods

Test guideline
Qualifier:
no guideline followed
Version / remarks:
no guideline available at the time of the study
Principles of method if other than guideline:
Pre-dates GLP and existing guidelines
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: no data, without inhibitor usually added to prevent polymerization.
Supplier: Röhm & Haas Company, Philadelphia, Pennsylvania

Ethyl Methacrylate; sp. gravity: 0.907 at 20 degrees C;
B.Pt.: 117 degrees C

Test animals

Species:
rat
Strain:
other: albino
Sex:
not specified

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
12700, 14510, 16330 and 18140 mg/kg (single dose)
No. of animals per sex per dose:
10 rats per dose
Details on study design:
 Doses were given via stomach tube to test animals and observed to toxic symptoms and death.
Statistics:
LD50 for rats was calculated by the method of Bliss (1938), but was not reported.

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
13 424 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Original value LD50:  14.8 ml/kg = 13424 mg/kg
Mortality:
Deaths in rats were as follows: 3/10  (low dose), 8/10 (next dose), and 10/10 rats at the two highest doses. Rats died within 1-96 hours.
Clinical signs:
Author noted that both species exhibited increased respiratory rate and lacrimation within 2-5 minutes; followed by motor weakness and decreased respiration, increased defecation and urination in 15-40 minutes. Animals which did not survive, died in a coma.

Any other information on results incl. tables

The LD50 estimated by the method of Bliss clearly demonstrates that the test material is of low acute toxicity by the oral route.

Applicant's summary and conclusion

Conclusions:
A reliable published acute oral LD50 in rats was 13424 mg/kg bw.
Executive summary:

A reliable published acute oral LD50 in rats was 13424 mg/kg bw.