2-chloroethanol

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:

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

Test material information

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.