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 EU/OECD guideline.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
(2001)
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
methyl 3-(chloromethyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxylate
EC Number:
936-879-0
Cas Number:
1247712-63-5
Molecular formula:
C11H9Cl2N3O2
IUPAC Name:
methyl 3-(chloromethyl)-1-(3-chloropyridin-2-yl)-1H-pyrazole-5-carboxylate

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: polyethylene glycol (400)
Doses:
2000 mg/kg body weight (bw)
No. of animals per sex per dose:
six female rats
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
2 500 mg/kg bw
Remarks on result:
other: 1/3 animals died at a initially dose level of 2000 mg/kg bw. No mortalities occurred at the follow-up dose level of 2000 mg/kg bw, therefore, a LD50 cut-off of 2500 mg/kg bw was derived according to OECD TG 423

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material caused mortality at a dose level of 2000 mg/kg bw (1/6). Clinical signs were decreased activity (1/6), hunched back (3/6), piloerection (3/6), prone position (1/6) and death (1/6). Body weight and body weight gain of the test material treated animals showed no indication of a treatment-related effect. Gritty beige material in the digestive content of the stomach and dark/red discoloured stomach glandular mucosa were found in the dead animal at necropsy and considered to be test item administration-related. Dark/red discoloration of the collapsed lungs was regarded as agonal/post mortem. There was no evidence of the macroscopic observations in surviving animals dosed at 2000 mg/kg bw and terminated on Day 14.