Chloroacetaldehyde

Repeated dose toxicity: other routes

Administrative data

Endpoint:

short-term repeated dose toxicity: other route

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

publication

Title:

Toxicity Profile of Chloroacetaldehyde

Author:

W.H. Lawrence, E.O. Dillingham, J.E. Turner, J. Autian

Year:

1972

Bibliographic source:

Journal of Pharmaceutical Sciences, Vol. 61, No. 1, Jan. 1972

Report date:

1971

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

8- 12 animals / group, only male rats were tested

GLP compliance:

not specified

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Chloroacetaldehyde

EC Number:

203-472-8

EC Name:

Chloroacetaldehyde

Cas Number:

107-20-0

Molecular formula:

C2H3ClO

IUPAC Name:

2-chloroacetaldehyde

Constituent 2

Reference substance name:

Chloroacetaldeyhde

IUPAC Name:

Chloroacetaldeyhde

Test material form:

other: solution in water

Details on test material:

30% solution in water, purity not reported.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

not specified

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

12 weeks

Frequency of treatment:

3 times a week

Doses / concentrations

Remarks:

Doses / Concentrations:
0.32 / 0.8 / 1.6 / 3.2 µL/kg, calculated as pure substance.
Applied as 0,5 % solution.

No. of animals per sex per dose:

12 / 8 animals per group, only one sex used.

Control animals:

yes, concurrent vehicle

Results and discussion

Results of examinations

Body weight and weight changes:

effects observed, treatment-related

Description (incidence and severity):

significant decrease

Haematological findings:

effects observed, treatment-related

Organ weight findings including organ / body weight ratios:

no effects observed

Histopathological findings: non-neoplastic:

effects observed, treatment-related

Details on results:

Weight gain: significant decrease for the 2 higher dose groups.
Hematology at the end of study: no effect in the two lower dose groups. At 1.6 uL/kg decrease in erythrocytes and lymphocytes; increase in segmented neutrophils, increase in bromosulphophthalein clearance. At 3.2 uL/kg decrease in erythrocytes and hemoglobin, increase in neutrophils and in clotting time.
Histopatholgy: no dose-related effect on the relative organ weight, focal, chronic bronchopneumonia of the lungs, more pronounced for the two higher dose groups. Changes of respiratory epithelia suggesting preneoplastic lesions at the two higher dose groups.

Effect levels

Dose descriptor:

NOEC

Effect level:

ca. 0.8 other: µL/kg

Based on:

test mat.

Sex:

male

Basis for effect level:

other: Weight gain, hematology, histopathology

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No or only minor observations in the two lower dose groups; weight gain and hematology effects in the two higher dose groups. Histopathologic effects were not dose-related.