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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
1-chloro-2,3-epoxypropane
EC Number:
203-439-8
EC Name:
1-chloro-2,3-epoxypropane
Cas Number:
106-89-8
Molecular formula:
C3H5ClO
IUPAC Name:
2-(chloromethyl)oxirane
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 or test system 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:
other: 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
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
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.