Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

Constituent 1
Chemical structure
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:
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)
- motor- coordination and -activity (abnormal gait and posture, catalepsy, loss of righting reflex and decreased activity)
- muscle tone (diminished body tone and paralysis).
Body weight:
The treated rats gained less weight than the control animals in the first few days after dosing. Thereafter the animals recovered and their weight gain appeared normal.
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.