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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A study summary was made available by ECHA under Article 25, Para 3., of EC Regulation 1907/2006

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 408 (1981); EEC Directive 87/302 (1987) Annex V-Part B
GLP compliance:
yes
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: feed
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
90 days treatment and 28 days reversibility period.
Frequency of treatment:
7d/week
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
Males 123.1, 406.4 and 1261.3 mg/kg bw/day
Basis:
nominal in diet
Remarks:
Doses / Concentrations:
Females 135.7, 478.5 and 1479.2 mg/kg bw/day
Basis:
nominal in diet
No. of animals per sex per dose:
Treatment groups: 20 males/20 females
Control group: 30 males/30 females
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
CAGE SIDE OBSERVATIONS: Yes

BODY WEIGHT: Yes :

FOOD CONSUMPTION: No data ; AND COMPOUND INTAKE (if feeding study): Yes

HAEMATOLOGY: No data

CLINICAL CHEMISTRY: Yes .

Sacrifice and pathology:
GROSS PATHOLOGY: No data
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Clinical biochemistry findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
no effects observed
Details on results:
CLINICAL SIGNS AND MORTALITY
There were no deaths and no clinical signs.

BODY WEIGHT AND WEIGHT GAIN
A decreased bodyweight gain was noted in males receiving 406.4 mg/kg bw/day (not statistically significant) and males and females receiving 1261.3 or 1479.2 mg/kg bw/day (statistically significant).

CLINICAL CHEMISTRY

A very slight increase in blood urea nitrogen was noted in rats receiving1261.3 or 1479.2 mg/kg bw/day (not statistically significant) This effect was reversible after 4 weeks without treatment.

HISTOPATHOLOGY: NON-NEOPLASTIC

No histopathological findings were considered to be treatment related.


Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
406.4 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: Decreased bodyweight gain in males and females receiving 1261.3 or 1479.2 mg/kg bw/day.
Dose descriptor:
NOEL
Effect level:
123.1 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test substance is of low subchronic oral toxicity to rats