Registration Dossier

Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Title:
No information
Author:
Anonymous
Year:
2011
Bibliographic source:
NICNAS (Australia)

Materials and methods

Test guideline
Guideline:
EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Crl:CD BR
Sex:
male/female

Administration / exposure

Route of administration:
other: oral: diet
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
90 days
Frequency of treatment:
daily in diet
Doses / concentrations
Remarks:
Doses / Concentrations:
0;200;1000;5000 ppm
Basis:
nominal in diet
No. of animals per sex per dose:
15

Results and discussion

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
74 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: 90 days
Dose descriptor:
LOAEL
Effect level:
17 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: 90 days

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion