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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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/EG, 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 at clinical examinations including
open field observations.


The functional observations revealed no findings pointing

to a neurotoxic potential.


Data of MA and LMA did not reveal any findings attributable
to the treatment with the test substance.


There was no statistically significant body weight

reduction in males up to 15000 ppm. Females receiving

15 ppm exhibited a body weight development comparable with
that of controls. In the groups 150 and 1500 ppm the
terminal body weights of females were each about 8 % lower
than that at 0 ppm.


The ophthalmoscopy done near the terminal sacrifice revealed
no evidence of treatment-related effects.

Laboratory findings:
Hematological investigations revealed no toxic effect on

red and white blood or blood coagulation parameters.


Clinical laboratory tests reveales no indicaiton of toxic
effects on enzyme activities as well as substrate and
electrolyte concentrations in plasma.


No changes were noted in urine parameters.


There was an increase in number and severity score of
splenic hematopoietic activity in 15000 ppm females.

Effects in organs:
Gross and histopathological investigations into other

organs and tissues as well as organ weight measurements

gave no indications of test substance-related functional

or morphological changes in both sexes.

Effect levels

open allclose all
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.
Dose descriptor:
NOEL
Effect level:
162.49 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