Registration Dossier

Diss Factsheets

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: GLP study according to EU / OECD-guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2-Difluoroethanamine
EC Number:
671-709-6
Cas Number:
430-67-1
Molecular formula:
C2H5F2N
IUPAC Name:
2,2-Difluoroethanamine

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The test item caused mortality (2/6) at a dose level of 2000 mg/kg bw.
Clinical signs:
Treatment with the test item at the dose level of 2000 mg/kg bw caused decreased activity (6/6), hunched back (6/6), prone position (1/6), piloerection (5/6) and death (2/6).
Body weight:
Body weight and body weight gain of test item treated animals showed no indication of a treatment-related effect.
Gross pathology:
Found dead:
Two females (2/6) were found dead on Day 1. Yellow liquid in the digestive content of the stomach and dark red multifocal discoloration of the stomach glandular mucosa found in these animals at necropsy were considered to be associated with administration of the test item.
Surviving animals:
No macroscopic observations were seen in surviving animals dosed at 2000 mg/kg bw and terminated on Day 14.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female CRL:(WI) rats.