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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to recommended guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 20% ethanol in corn oil.
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0
Basis:
actual ingested
Remarks:
Doses / Concentrations:
15
Basis:
actual ingested
Remarks:
Doses / Concentrations:
50
Basis:
actual ingested
Remarks:
Doses / Concentrations:
150
Basis:
actual ingested
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
Clinical observations: No deaths occurred at any dose Clinically, fur loss was seen in 2 out of 5 females treated at 150 mg/kg/day from week 3 of the treatment period onwards
Mortality:
no mortality observed
Description (incidence):
Clinical observations: No deaths occurred at any dose Clinically, fur loss was seen in 2 out of 5 females treated at 150 mg/kg/day from week 3 of the treatment period onwards
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Females treated at 150 mg/kg/day showed a lower mean body weight starting from the third week of dosing, with a reduction of about 8% in comparison to the controls at the end of the study
Food consumption and compound intake (if feeding study):
no effects observed
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
no effects observed
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
No important variations were noted at any dose. A possible minor treatment-related change was a decrease in platelet value for both sexes treated at 150 mg/kg/day
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
The possibly minor treatment-related effects were increases in serum triglyceride level and in alkaline phosphatase activity in both sexes treated at 150 mg/kg/da
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
no effects observed
Details on results:
Clinical observations:
No deaths occurred at any dose

Clinically, fur loss was seen in 2 out of 5 females treated at 150 mg/kg/day from week 3 of the treatment period onwards

No effects on body weight growth or food consumption were found in either sex treated at 15 and 50 mg/kg/day or in males given the high dose (150 mg/kg/day). Females treated at 150 mg/kg/day showed a lower mean body weight starting from the third week of dosing, with a reduction of about 8% in comparison to the controls at the end of the study

No eye modifications were noted

Laboratory findings:
No important variations were noted at any dose. A possible minor treatment-related change was a decrease in platelet value for both sexes treated at 150 mg/kg/day

No changes of note were seen in animals treated at 15 and 50 mg/kg/day

The possibly minor treatment-related effects were increases in serum triglyceride level and in alkaline phosphatase activity in both sexes treated at 150 mg/kg/day

No treatment-related modifications were seen

Effects in organs:
No treatment-related changes were noted

HISTOLOGY

Treatment-related changes associated with daily oral administration of the test article were limited to the anterior lobe of the pituitaries of male rats treated with the high dose, consisting of increased presence of cells having vacuolated cytoplasm

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: see 'Remark'
Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: Females treated at 150 mg/kg/day showed a lower mean body weight starting from the third week of dosing, with a reduction of about 8% in comparison to the controls at the end of the study
Dose descriptor:
NOEL
Effect level:
50 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for specific target organ toxicity following repeated exposure.