dichloromethane; methylene chloride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline 401 and GLP-compliant study

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dichloromethane

EC Number:

200-838-9

EC Name:

Dichloromethane

Cas Number:

75-09-2

Molecular formula:

CH2Cl2

IUPAC Name:

dichloromethane

Details on test material:

Dichloromethane (Production: TA, June 1985), a volatile colourless liquid. The test material was supplied by Solvay and Cie, Bruxelles, Belgium. The compound was diluted with corn oil to a final concentration of 0.4 g/ml.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

SPF-derived males (180-200 g) and femals (160-180 g) at arrival

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

once, 14 days observation period

Doses:

2000 mg/kg bw (dose volume: 5 ml/kg)

No. of animals per sex per dose:

5/sex/dose

Control animals:

yes

Details on study design:

For ethical reasons the control group was used for a number of studies which were carried out in parallel.

Investigated parameters: clinical signs, body weights and body weight gains, autopsy, organ weights and histopathology.

Statistics:

The results were evalulated with an analysis of variance followd by a Student t-test (two-sided).

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

Mortality was not observed.

Clinical signs:

other: The clinical signs were indicative of an effect on the: - autonomic nervous system (decreased respiratory rate, respiratory difficulties, ptosis, piloerection and salivation) - central nervous system (possitional passivity, twitches and convulsions) - mot

Gross pathology:

Examination of the rats revealed swollen or slighty swollen livers in all treated animals.
No treatment related effects on absolute and relative organ weights were observed.

Other findings:

Microscopic examination of the tissues revealed no clear changes attributable to treatment in the males. Four females showed hydropic degeneration of liver parenchchyma cells and three females showed cloudy swelling of the renal cortical tubules. However, changes in degree and incidence were too slight to warrant any firm conclusion as to whether they were treatment related.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 was in excess of 2000 mg/kg bw.