Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
Deviations:
not specified
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 2, 10, 100 and 1000 mg/kg bw/day (male/female)
Basis:
other: nominal
No. of animals per sex per dose:
Male: 15 animals at 0 mg/kg bw/day
Male: 10 animals at 2 mg/kg bw/day
Male: 10 animals at 10 mg/kg bw/day
Male: 10 animals at 100 mg/kg bw/day
Male: 15 animals at 1000 mg/kg bw/day
Female: 15 animals at 0 mg/kg bw/day
Female: 10 animals at 2 mg/kg bw/day
Female: 10 animals at 10 mg/kg bw/day
Female: 10 animals at 100 mg/kg bw/day
Female: 15 animals at 1000 mg/kg bw/day
Control animals:
yes

Results and discussion

Results of examinations

Details on results:
Clinical observations: No clinical effects were noted in treated animals then compared to the control group.
Laboratory findings: No changes to blood or body fluides were noted.
Effects in organs: No treatment related findings were observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOAEL and NOEL > 2000 mg/kg bw (male/female)
Executive summary:

The oral repeated dose toxicity of the test substance has been determined in a subchronic GLP study with rats (males and females) according to OECD Guideline 408 (90-days, 7 days a week, of oral exposure (gavage) at doses of 0, 2, 10, 100 and 1000 mg/kg bw/day). The test substance was on the whole well tolerated up to and including the highest dosage administered because no signs of toxicity were observed. One animal, which was found dead during the study, was subjected to a gross postmortem examination and all protocol-specified tissues were examined microscopically, no treatment related effects were observed. Oral gavage administarion of the test material, for at least 90 days to rats at the highest dose level of 1000 mg/kg/day did not cause histomorphologic lesions in any of the representative sections of tissues. Accordingly, a NOEL and NOAEL of > 1000 mg/kg bw/day have been determined.