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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
biochemical or cellular interactions
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets scientific standards with acceptable restrictions (e.g. partly limited documentation, e.g. no details about the test substance).

Data source

Reference
Reference Type:
publication
Title:
An investigation of the role of microsomal oxidative metabolism in the in vivo genotoxicity of 1,2-dichloroethane
Author:
Storer RD & Conolly RB
Year:
1985
Bibliographic source:
Tox Appl Pharmacol 77: 36-46

Materials and methods

Principles of method if other than guideline:
Biochemical effects in the liver of mice after i.p. injection
GLP compliance:
no
Type of method:
in vivo

Test material

Constituent 1
Reference substance name:
Reference substance 001
Details on test material:
no details

Test animals

Species:
mouse
Strain:
B6C3F1
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
physiological saline
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
single injection
Post exposure period:
see results
Doses / concentrations
Remarks:
Doses / Concentrations:
24; 48; 72.5 mg/kg bw in the 1st trial or 24; 48; 72.5; 96.6 mg/kg bw in the 2nd
Basis:

No. of animals per sex per dose:
see below
Control animals:
other: untreated controls in trial 1 and concurrent vehicle control in trial 2

Results and discussion

Details on results:
1st trial: depletion to 30% of untreated control level at the high dose level 1.5 h after injection, slight amelioration after 3 h. Similar but less severe effects at lower doses.
2nd trial: rel. liver weight significantly increased at the high dose level; serum IDH and AAT significantly increased at the high dose level.

Applicant's summary and conclusion

Conclusions:
Toxic dose levels resulted in depletion of liver glutathione and in liver toxicity in mice.
Executive summary:

The study meets scientific standards with acceptable restrictions (e.g. partly limited documentation, e.g. no details about the test substance).

In trial 1 4 male B6C3F1 mice were i.p. injected once with 24, 48, or 72.5 mg/kg bw (untreated control) and liver glutathione levels measured 1.5 and 3 h after application. A depletion to 30% of untreated control level at the high dose level 1.5 h after injection was measured and a slight amelioration was found after 3 h. Similar but less severe effects were found at lower doses.

In the 2nd trial 3 -6 male B6C3F1 mice per groupp received single i.p. injections of 0, 24, 48, 72.5, or 97 mg/kg bw and sacrificed 24 h later. Liver weight was significantly increased at the high dose level as well as serum iditol dehydrogenase and serum alanine aminotransferase.

Conclusion: Toxic dose levels resulted in depletion of liver glutathione and in liver toxicity in mice.