Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 2007-11-20 till 2007-12-19
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline-conform study under GLP without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
483-300-8
EC Name:
-
Cas Number:
99580-93-5
Molecular formula:
Hill formula: C3H13N2O3P CAS formula: C2H8N2.CH5O3P
IUPAC Name:
1,2-Ethanediamine methylphosphonate
Test material form:
solid: bulk
Details on test material:
Batch number: FEB 278-810

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Species/strain: Wistar Hsd:HanRcc (SPF)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Aqua ad inject
Control animals:
no
Statistics:
not necessary

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Female: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
No treatment related effect was observed during the course of the study.
Body weight:
Throughout the 14-days observation period weight loss was recorded for animal 2 in step 1, loosing weight between the first and the second week. No weight loss was recorded in any other animal. The weight gain was within the expected range.
Gross pathology:
Effects on organs:
No treatment related effects were observed in any animal of any steps.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item shows no orally toxic characteristics.
According to GHS (Globally Harmonized Classification System) the test item was classified into Category 5 (LD50 cut-off: unclassified).