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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:
weight of evidence
Study period:
1982
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Very few information, animals were observed for 14 days but no information on the number of animals and tested dose. Only LD50 values are reported.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
In vivo Assessment of Immunotoxicity
Author:
Munson AE, Sanders VM, Douglas KA, Sain LE, Kauffmann BM & White KL
Year:
1982
Bibliographic source:
Environ. Health Perspect. 43: 41-52

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
other: no data
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
1,2-dichloroethane, Lot #120487, was obtained from Aldrich Chemical Co., Milwaukee, Wisconsin, USA.

Test animals

Species:
mouse
Strain:
CD-1
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Breeding Laboratories, Wilmington, Mass., U.S.A.
- Age at study initiation: 6 weeks old
- Fasting period before study: 18 hours prior to dosing
- Housing: In goups of four animals in shoebox plastic cages with sawdust bedding
- Diet: Agway Lab Chow ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 70-75 degree F (about 21-24 degree C)
- Humidity: 40-60 %
- Photoperiod: 12 hours dark/ 12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Solutions of dichloroethane were prepared fresh daily for acute studies and the appropriate concentrations were administered by gavage in a volume of 0.01 mL/g bw to achieve the desired dose. The chemical was administered to male and female mice by an 18-gauge stainless steel stomach tube 18 hours after fasting from food.
Doses:
no data
No. of animals per sex per dose:
no data
Control animals:
not specified
Details on study design:
Following gavage, the mice were observed for overt toxicological effects continously for 4 hours and then twice daily for 14 days. Mice dying during the experimental procedure were necropsied, and gross pathological changes were described. Mice surviving the 14-day observation period were sacrificed and gross pathology described.
Gross pathology: brain, liver, spleen, lungs, thymus,  kidneys, testes (organ weight)
Statistics:
Log probit analysis was used to determine the LD50 and the 95% confidence limits.

Results and discussion

Preliminary study:
no data
Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
489 mg/kg bw
95% CL:
424 - 552
Sex:
female
Dose descriptor:
LD50
Effect level:
413 mg/kg bw
95% CL:
337 - 499
Mortality:
The mice died over a 48-hour period. Those surviving 48 hours recovered and appeared normal at the end of the 14-day observation period.
LD50 (male) = 489 mg/kg bw (95 % CL: 424-552 mg/kg bw); LD50 (female) = 413 mg/kg bw (95 % CL = 337-499 mg/kg bw).
Clinical signs:
no data
Body weight:
no data
Gross pathology:
Target organs appeared to be liver and lungs.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
Oral administration of 1,2-dichloroethane to mice by gavage:
LD50 (male) = 489 mg/kg bw; LD50 (female) = 413  mg/kg bw
Executive summary:

In an acute oral toxicity study, groups of fasted (18 hours), 6 -week-old CD-1 mice were given a single oral dose of 1,2 -dichloroethane and observed for 14 days.

The mice died over a 48 -hour period. Those surviving 48 hours recovered and appeared normal at the end of the 14 -days observation period. Macroscopically, target organs appeared to be liver and lungs. The calculated LD50 values using log probit analysis were 489 mg/kg bw (95% C.I. 424 -552 mg/kg bw) and 413 mg/kg bw (95% C.I. 337-499 mg/kg bw) for male and female mice, respectively.

1,2 -dichloroethane is of low acute oral toxicity based on the LD50 in male and female CD-1 mice.