1,2-dichloroethane

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1948

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

other: SIDS Initial Assessment Report

Title:

Mellon Inst. Industr. Research. The Toxicity of Ethylene Dichloride. 1948 in OECD SIDS report 1,2-dichloroethane

Author:

Anonymous

Year:

2002

Bibliographic source:

SIDS Initial Assessment Report for 14th SIAM (Paris, France, March 2002)

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal 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

Test animals

Species:

rabbit

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

no details given

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

no data

Duration of exposure:

no data

Doses:

Occluded applications : 3.16, 3.98, 4.45 and 5.0 mL/kg for 24 h (= 3972, 5000, 5594 and 6285 mg/kg bw)

No. of animals per sex per dose:

6-11 animals

Control animals:

not specified

Details on study design:

no data

Statistics:

Probit analysis

Results and discussion

Preliminary study:

no data

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

4 890 mg/kg bw

95% CL:

4 270 - 5 600

Mortality:

Mortality observed within 14 days:
2/6 animals at 3972 mg/kg bw  within 5-10 days
3/11 animals at 5000 mg/kg bw within 1-5 days
8/9 animals at 5594 mg/kg bw within 1-11 days
5/6 animals at 6285 mg/kg bw within 1 day
The LD50 calculated using the method of probits was 3.89 mL/kg bw (3.40-4.46 mL/kg bw) or 4890 mg/kg bw (4270-5600 mg/kg bw).

Clinical signs:

other: No data

Gross pathology:

Gross necropsy evaluation revealed no adverse effects.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Acute dermal toxicity to male rabbits:
The calculated LD50 by the method of probits was 3.89 mL/kg bw (3.40-4.46 mL/kg bw) or 4890 mg/kg bw (4270-5600 mg/kg bw).

Executive summary:

In an acute dermal toxicity study, groups of male rabbits (6 -11 animals/dose level) were dermally exposed to 1,2 -dichloroethane at doses of 3972, 5000, 5594 or 6285 mg/kg bw and observed for 14 days. Mortality was observed in 2/6 at 3972 mg/kg bw within 5 -10 days, 3/11 at 5000 mg/kg bw within 1 -5 days, 8/9 at 5594 mg/kg bw within 1 -11 days and 5/6 at 6285 mg/kg bw within 1 day. Weight loss was reported in most survivors. Gross necropsy evaluation revealed no adverse effects. The calculated LD50 by the method of probits was 3.89 mL/kg bw (3.40 -4.46 mL/kg bw) or 4890 mg/kg bw (4270–5600 mg/kg bw).