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Administrative data

Endpoint:
short-term repeated dose 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:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Reference substance name:
Body responsible for the test
IUPAC Name:
Body responsible for the test
Test material form:
not specified

Test animals

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

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Method of administration: admixed in food
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
Male: 0, 8.95, 59.1 and 1130 mg/kg bw/day; female: 0, 8.62, 55.5 and 1090 mg/kg bw/day
Basis:
no data
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 8.95 mg/kg bw/day
Male: 5 animals at 59.1 mg/kg bw/day
Male: 10 animals at 1130 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 8.62 mg/kg bw/day
Female: 5 animals at 55.5 mg/kg bw/day
Female: 10 animals at 1090 mg/kg bw/day
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
not specified
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
Clinical observations:
There were no clinicals signs nor signs of systemic toxicity.
Laboratory findings:
The treatment had no influence on the hematlogical profile and non on blood chemistry parameters.
Effects in organs:
No treatment related changes were observed.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 090 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
female
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
1 090 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
female
Basis for effect level:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Doses at which no effect were observed: 1090 mg/kg in females and 1130 mg/kg in males.

Applicant's summary and conclusion

Conclusions:
NOAEL = 1090 mg/kg in females;
doses at which no effect were observed: 1090 mg/kg in females and 1130 mg/kg in males
Executive summary:

The oral repeated dose toxicity of the test substance has been determined in a subacute GLP study with rats (3 groups of males and 3 groups of females) according to OECD Guideline 407 and EU Method B.7 (28-days, 7 days a week, of oral exposure (admixed in food) at doses of 0, 8.95, 59.1 and 1130 mg/kg bw/day (male) and 0, 8.62, 55.5 and 1090 mg/kg bw/day (female), respectively). The test substance was on the whole well tolerated up to and including the highest dosage administered because no signs of toxicity were observed. A NOEL and NOAEL of 1090 mg/kg bw/day have been determined.