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Toxicological information

Acute Toxicity: dermal

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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:
other: Comparative study, screening test, basic data given, based on scientific principles, results conclusive.
Cross-reference
Reason / purpose:
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:
OECD Guideline 402 (Acute Dermal 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

Test animals

Species:
rabbit
Strain:
not specified
Sex:
male
Details on test animals 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:
No data
Body weight:
Weight loss was reported in most survivors.
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
Remarks:
Migrated information
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).