2-chloroethanol

Repeated dose toxicity: other routes

Administrative data

Endpoint:

sub-chronic toxicity: other route

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study meets scientific standards with acceptable restrictions (partly limited documentation).

Data source

Reference

Reference Type:

publication

Title:

Toxicity of ethylene chlorohydrin II: subacute toxicity and special tests

Author:

Lawrence WH, Itoh K, Turner JE, and Autian J

Year:

1971

Bibliographic source:

J Pharmacol Sci 60: 1163-1168

Materials and methods

Principles of method if other than guideline:

Toxic effects in rats after thrice weekly i.p. injection for 3 months

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Details on test material:

Purity > 99%
Source: Matheson, Coleman, and Bell, East Rutherford, N. J.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

water

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

12 weeks

Frequency of treatment:

Thrice weekly (Mo, We, Fr)

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 6.4, 12.8, 32 mg/kg bw/injection; concentrations/application volume not given

No. of animals per sex per dose:

12 male rats per dose; at 0 and 12.8 mg/kg bw totally 24 animals (experiment repeated)

Control animals:

yes, concurrent vehicle

Details on study design:

Post-exposure period: keine Angaben

Results and discussion

Effect levels

Dose descriptor:

NOAEL

Effect level:

12.8 other: mg/kg bw/injection

Sex:

male

Basis for effect level:

other: overall effects

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Survival

in the 1st trial 4/12 rats died at 12.8 mg/kg bw; authors presumed an overdose and repeated the experiment; no mortality was found at this dose level. At 32 mg/kg bw 6/12 rats died. No mortality occurred at 6.4 mg/kg bw.

Body weight gain, food consumption, hematology, pathology: no significant treatment related effects.

Applicant's summary and conclusion

Conclusions:

No adverse effects were detected in male rats after thrice weekly i.p. injection for 12 weeks at a dose level of 12.8 mg/kg bw/injection, the LOAEL was 32 mg/kg bw/injection.

Executive summary:

The study meets scientific standards with acceptable restrictions (partly limited documentation).

In a subchronic study 12 -24 male Sprague-Dawley rats per group received thrice weekly i.p. injections of 0, 6.4, 12.8, 32 mg/kg bw/injection for 12 weeks. Clinical signs, food consumption, body weight, hematology, necropsy data, organ weights were recorded and histopathology of selected organs performed. Survival was reduced at 32 mg/kg bw. No further treatment related effects were detected.

Conclusion: No adverse effects were detected in male rats after thrice weekly i.p. injection for 12 weeks at a dose level of 12.8 mg/kg bw/injection, the LOAEL was 32 mg/kg bw/injection.