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EC number: 203-458-1 | CAS number: 107-06-2
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:
- documentation insufficient for assessment
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:
- 1 982
- 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
- 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.
Constituent 1
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 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:
- other: 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.
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