Benzoic acid, 2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl]-

Repeated dose toxicity: oral

Administrative data

Endpoint:

repeated dose toxicity: oral

Adequacy of study:

other information

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 96/54/EWG, B.26; OECD 408 (1998)

GLP compliance:

yes

Limit test:

no

Test animals

Species:

other: rat, Wistar Hsd Cpb:WU

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

other: diet

Details on oral exposure:

Method of administration:
oral

Duration of treatment / exposure:

Test duration: 90 days

Frequency of treatment:

Dosing regime: 7 days/week

No. of animals per sex per dose:

Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 1.19 mg/kg bw/day
Male: 10 animals at 12.34 mg/kg bw/day
Male: 10 animals at 120.19 mg/kg bw/day
Male: 10 animals at 1203.8 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 1.63 mg/kg bw/day
Female: 10 animals at 16.08 mg/kg bw/day
Female: 10 animals at 162.49 mg/kg bw/day
Female: 10 animals at 1436.3 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:

Clinical observations:
No animal died prescheduled.

No clinical signs attributable to the test substance were
noted up to 15000 ppm. The reduced food consumption (- 13 %)
in females ingesting 15000 ppm corresponded to a slight

but statistically significant depression in body weights

(- 10 %) and body weight gain at termination. There was no
effect on food consumption and body weight gain in males up
to 15000 ppm.

No test substance-related effects were detected during
functional observational battery including functional
observations, behavioural assessments, reflex testing; and
motor activity measurements.

Laboratory findings:
Haematological investigations revealed no toxic effect on
red and white blood cells or coagulation parameters.
Isolated means marked as statistically significant are of no
toxicological relevance, because the deviations to control
means were too small and not dose-related distributed.
Clinical biochemistry tests revealed no indications of toxic
effects on enzyme activities as well as substrate and
electrolyte concentrations in plasma.

No test substance-related differences in urinalysis
parameters were noted when compared with the control values.

Effects in organs:
There was statistically significant increase in relative
brain and pituitary weight in females at 15000 ppm, which
considered being due to the reduced body weight and,
therefore secondary.

At necropsy pale discoloration of the liver (incidence:
0/3/4/3/4) and distinct lobulation of the liver (2/4/7/5/4)
were reported in several animals of all dose groups. No
histopathological correlate could be found to the
macroscopic findings noted in the liver.

Histopathology revealed an increase in number (incidence:
0/0/1/2/4) and severity score of splenic haematopoietic
activity in 15000 ppm females. The hemosiderin content of
the spleen was similar in untreated and treated animals of
both sexes.

Gross and histopathological investigations on other organs
and tissues as well as organ weight measurements gave no
indication of test substance-related functional or
morphological changes in both sexes.

Effect levels

Dose descriptor:

NOAEL

Effect level:

1 203.8 mg/kg bw/day (nominal)

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:

Classified as: Not classified