Registration Dossier
Registration Dossier
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EC number: 203-459-7 | CAS number: 107-07-3
Specific investigations: other studies
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:
- 1 985
- 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
- Reference substance name:
- Reference substance 001
- Details on test material:
- no details
Constituent 1
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.
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