Registration Dossier

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: study was preformed according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
2010

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Doses:
four levels: 5, 50, 300 and 2000 mg/kg body weight
No. of animals per sex per dose:
3 animals of a single sex per step.
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 - < 5 000 mg/kg bw
Mortality:
It was noted the death of two rats treated at 2000 mg/kg body weight at 22 hours 55 minutes and at 27 hours 35 minutes post-dose, respectively. The macroscopical examination of the dead animals revealed a thinning of the forestomach (2/2) associated with a white coloration (1/2), a thinning of the corpus associated with a dark red to black coloration (1/2), and presence of a red liquid in the thorax (2/2).
Clinical signs:
In the survival animals, it was noted from 24 hours post-dose, a dyspnoea (4/4), tremors (4/4), piloerection (4/4) and a decrese in spontaneous activity (2/4). The animals recovered a normal behaviour on 4 days.
Body weight:
A decrease in the body weight was noted on day 2 compared to day 0: -2.5% versus +10.1% in the historical control group. The animal recoverd a normal body weight evolution on day 7.
Gross pathology:
The macroscopical examination of the animal at the end of the study did not reveal treatment related change.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The presented data are reliable and adequate.
Executive summary:

According to the criteria for classification, packaging and labelling of dangerous substance and preparations in accordance with E.E.C. Directives 67/548, 2001/59 and 99/45, the test item must not be classified. In accordance with the regulation EC No 1272/2008, the test item need not be classified. No signal word or hazard statement is required.