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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:
other: Comparable with OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details on test substance or concentration in vehicle; dose levels not clearly specified, no data on clinical signs or necropsy)

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity data List V
Author:
Smith HF, Carpenter CP, Weil CS, Pozzani UC
Year:
1954
Bibliographic source:
J Ind Hyg Occup Med 10: 61-68

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
see rationale for reliability
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethylene carbonate
EC Number:
202-510-0
EC Name:
Ethylene carbonate
Cas Number:
96-49-1
Molecular formula:
C3H4O3
IUPAC Name:
1,3-dioxolan-2-one
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Ethylene carbonate
- Purity: > 99%
- Physical state: fine crystals

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Source: rats raised in the authors own colony
Diet: Rockland rat diet complete
Initial body weight: 90 to 120 g
Rats not fasted before dosing
No further data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
No details
Doses:
dosages in a logarithmic series (no further data)
No. of animals per sex per dose:
Groups of five male rats
Control animals:
no
Details on study design:
Post exposure observation period 14 days
Statistics:
The LD50 value and its fiducial range are estimated by the method of Thompson (Bact. Rev. 11 :115, 1947) using the tables of Weil (Biometrics 8 :249, 1952).

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
10 400 mg/kg bw
95% CL:
7 940 - 13 620
Mortality:
no further data
Clinical signs:
other: no data
Gross pathology:
no data
Other findings:
no

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In male rats the LD50 is 10400 mg/kg bw.
Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. no details on test substance or concentration in vehicle; dose levels not clearly specified, no data on clinical signs or necropsy).

Groups of 5 male Carworth-Wistar rats were gavaged with dosages in a logarithmic series. The post exposure observation period was 14 days. The authors calculated a LD50 value of 10400 mg/kg bw. The test substance is practically non-toxic.

Conclusion: In male rats the LD50 is 10400 mg/kg bw.