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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
sub-chronic 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:
1999
Report date:
1999

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:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
20 males
20 females

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on analytical verification of doses or concentrations:
15, 150, or 500 mg/kg/day
Duration of treatment / exposure:
four weeks
Frequency of treatment:
once a day

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
no deaths occurred during the study
Mortality:
no mortality observed
Description (incidence):
no deaths occurred during the study
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
a slightly higher mean body weight gain and food consumption were observed in females given 500 mg/kg/day
Haematological findings:
no effects observed
Description (incidence and severity):
no difference between control and treated group amoung hematological parameters.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
15 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:
The administration of the test substance Pseudo Kharismal Step 1 daily by gavage for four weeks to rats produced clinical and histopathological changes in females given 500mg/kg/day. No specific signs of a neurotoxic actions were observed. No signs of toxicity were recorded at 15 and 150 mg/kg/day. Consequently, under our experimental conditions, the No Observed Effect Level (NOEL) is established at 150 mg/kg/day.
Executive summary:

The administration of the test substance Pseudo Kharismal Step 1 daily by gavage for four weeks to rats produced clinical and histopathological changes in females given 500mg/kg/day. No specific signs of a neurotoxic actions were observed. No signs of toxicity were recorded at 15 and 150 mg/kg/day. Consequently, under our experimental conditions, the No Observed Effect Level (NOEL) is established at 150 mg/kg/day.