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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:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Not GLP, study was conducted in accordance with Guidelines and sufficient data is available for the interpretation of results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 81-1 (Acute Oral Toxicity)
Deviations:
no
Remarks:
Not specified in report
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
99.8% epichlorohydrin
0.11% 2,3-dichloropropene
0.01% beta-chloroallyl alcohol

Test animals

Species:
rat
Strain:
other: Fischer 344 and Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Source: Fischer 344 rats: Charles River Breeding Laboratories, Portage, MI; Sprague-Dawley rats: Spartan Research Animals, Inc., Haslett, MI

Age: 7-8 weeks

Mean Weight at Study Initiation: male Fischer 344 rats: 103-185 g female Fischer 344 rats: 80-132 g; male Sprague-Dawley rats: 262-325 g; female Sprague-Dawley rats: 192-208 g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Doses per time period: Single-dose oral gavage

Maximum volume administered: Fischer 344 rats: 2.8 ml; Sprague-Dawley rats: 4.7 ml

Post-Dose Observation Period: 2 weeks
Doses:
25, 50, 100, 200, 210, 225, 252, 398, 795 mg/kg for male and female Fischer 344 rats

24, 50, 100, 200, 398 and 795 mg/kg for male and female Sprague-Dawley rats.
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
Examinations: Clinical observations, gross pathological examination
Statistics:
Statistics: The acute oral median lethal dose and approximate slope of the dose-response curve for both strains were calculated by the moving average method of Thompson and Weil (Biometrics 8: 51-54, 1952).

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
282 mg/kg bw
95% CL:
117 - 448
Remarks on result:
other: Sprague-Dawley rat calculated using moving average method
Sex:
female
Dose descriptor:
LD50
Effect level:
175 mg/kg bw
95% CL:
116 - 306
Remarks on result:
other: Sprague-Dawley rat calculated using moving average method
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 218 mg/kg bw
Remarks on result:
other: Fischer 344 rat calculated using moving average method
Sex:
female
Dose descriptor:
LD50
Effect level:
210 mg/kg bw
95% CL:
203 - 216
Remarks on result:
other: Fischer 344 rat calculated using moving average method
Mortality:
MORTALITY:

# Dead/# Treated
Dose Male Female Male Female
(mg/kg) S-D S-D CDF CDF
25 0/5 0/5 0/5 0/5
50 0/5 0/5 0/5 0/5
100 0/5 0/5 0/5 0/5
200 1/5 2/5 0/5 0/5
210 --- --- 0/5 3/5
225 --- --- 5/5 5/5
252 --- --- 5/5 5/5
398 4/5 5/5 5/5 5/5
795 5/5 5/5 5/5 5/5

---: not tested

Time to death not available.
Clinical signs:
CLINICAL SIGNS:

# Affected/# Treated
Dose Sign Male Female Male Female
(mg/kg) S-D S-D CDF CDF
25 0/5 0/5 0/5 0/5
50 0/5 0/5 0/5 0/5
100 0/5 0/5 0/5 0/5
200 Slight
Lethargy 5/5 5/5 5/5 0/5
210 Slight
Lethargy --- --- 5/5 5/5
Piloerection --- --- 5/5 5/5
225 Lethargy --- --- 5/5 5/5
Piloerection --- --- 5/5 5/5
252 Extreme
Lethargy --- --- 5/5 5/5
Piloerection --- --- 5/5 0/5
Shallow
Breathing --- --- 5/5 5/5
Darkened
Extremities --- --- 5/5 0/5
398 Lethargy 5/5 5/5 5/5 5/5
Hyper-
activity 1/5 0/5 0/5 0/5
Watery eyes 0/5 0/5 0/5 5/5
Diarrhea 0/5 0/5 0/5 5/5
795 Lethargy 5/5 5/5 5/5 5/5
Severe
Diarrhea 0/5 0/5 0/5 5/5

---: not tested

Body weight:
Body weight data indicated that results were essentially comparable between both strains.
Gross pathology:
GROSS PATHOLOGY:
Roughening and thickening of the squamous epithelium of the non-glandular stomach was observed in rats given 100-210 mg/kg with Sprague-Dawley rats exhibiting an increased incidence compared to Fischer 344 rats. Other findings were non-specific and not considered treatment-related.

Other findings:
POTENTIAL TARGET ORGANS: None identified.

SEX-SPECIFIC DIFFERENCES: No significant differences observed.

Any other information on results incl. tables

The LD50 results were very similar between both strains and sexes with individual values ranging from 175 -282 mg/kg..

Applicant's summary and conclusion

Interpretation of results:
Category 3 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The LD50 was calculated in male and female Sprague-Dawley and Fischer 344 rats. The LD50 ranged from 175-282 mg/kg.
Executive summary:

The LD50 was calculated in male and female Sprague-Dawley and Fischer 344 rats for a number of compounds. The LD50 for epichlorohydrin ranged from 175-282 mg/kg.