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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
HPLC, UV-detection at 350 nm
Duration of treatment / exposure:
28 d
Frequency of treatment:
substance mixed with microgranulated feed
Doses / concentrations
Remarks:
Doses / Concentrations:
50, 200, 1000 mg/kg/day
Basis:
nominal in diet
No. of animals per sex per dose:
5 animals per sex per dose

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
one female that received 1000 mg/kg dose was killed for ethical reasons on day 4 of treatment.
Mortality:
no mortality observed
Description (incidence):
one female that received 1000 mg/kg dose was killed for ethical reasons on day 4 of treatment.
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
no effects observed
Food efficiency:
no effects observed
Water consumption and compound intake (if drinking water study):
not examined
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
no effects observed
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
In males treated with 1000 mg/kg/day, marginally elevated mean absolute kidney weights were noted when compared with the controls. The mean absolute and relative organ weights of the rats treated with 50 and 200 mg/kg/day were unaffected.
Gross pathological findings:
no effects observed

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
> 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Dose descriptor:
NOEL
Effect level:
1 000 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