Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 October 2015 - 24 December 2015
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: white solid
Details on test material:
Roche number : RO0401413-000
Formula : C8H5ClFN
Molecular weight : 169,6 g/mol
Batch : 280001T01O
Purity : 100 % (m/m)
Expiry date : 31 December 2015
Storage conditions : room temperature in the dark under nitrogen

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
2000 mg/kg and 300 mg/kg
No. of animals per sex per dose:
1 female rat at 2000 mg/kg
5 female rats at 300 mg/kg
Control animals:
no

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 300 - <= 2 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The acute oral median lethal dose (LD50) of PAC-Nitrile in the female Wistar strain rat was estimated to be in the range of 300 -2000 mg/kg body weight