Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-difluoro-1,3-benzodioxole
EC Number:
216-431-4
EC Name:
2,2-difluoro-1,3-benzodioxole
Cas Number:
1583-59-1
Molecular formula:
C7H4F2O2
IUPAC Name:
2,2-difluoro-2H-1,3-benzodioxole

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Doses:
2000 mg/kg b.w.
No. of animals per sex per dose:
3

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died immediately after administration due to a technical failure. All other animals survived until the end of the study period.
Clinical signs:
Slightly ruffled fur was noted in all animals at the 1- hr observation and persisted up to test day 3 in all animals of the second treated group and up to test day 4 in the two remaining animals of the first treated group. Hunched posture was additionally noted from the 2-hr reading to test day 3 in the first treated group and from the 1-hr reading to test day 2 in the second treated group.
Body weight:
within the range.
Gross pathology:
The appendix of the caecum of one animal was blue-red to violed discolored, with hyperemic blood vessels. The appendix was empty while the main part of the caecum was full. Injury of the trachea was noted at the unscheduled necropsy from the animal which died immediately after treatment and permitted to conclude about a technical failure. No macroscopic findings were recorded in the other animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The median lethal dose of the test item after single oral administration to female rats, observed over a period of 14 days is greater than 2000 mg/kg b.w..