Reaction mass of carbon tetrachloride and chloroform and 1,2-dichloroethane

Acute Toxicity: oral

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 for cross-reference:

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

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

other: no data

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,2-dichloroethane

EC Number:

203-458-1

EC Name:

1,2-dichloroethane

Cas Number:

107-06-2

Molecular formula:

C2H4Cl2

IUPAC Name:

1,2-dichloroethane

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 or test system 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 levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

489 mg/kg bw

95% CL:

424 - 552

Effect levels 2

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

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.