Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
repeated dose toxicity: oral, other
Remarks:
5-day treatment study
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: study well documented, meets generally accepted scientific principles, with very limited documentation
Justification for type of information:
Justification for Read Across is given in Section 13 of IUCLID

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
The toxicity of the substance was evaluated after repeated oral administration for 5 consecutive days.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: mean of 383 g
No further details.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
physiological saline
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
5 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Dose / conc.:
50 mg/kg bw/day (actual dose received)
Dose / conc.:
500 mg/kg bw/day (actual dose received)
Dose / conc.:
5 000 mg/kg bw/day (actual dose received)
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
No data.
Positive control:
No data.

Examinations

Observations and examinations performed and frequency:
No data.
Sacrifice and pathology:
No data.
Other examinations:
No data.
Statistics:
No data.

Results and discussion

Results of examinations

Description (incidence and severity):
No clinical signs were reported
Description (incidence):
No mortality was observed

Effect levels

Dose descriptor:
NOEL
Effect level:
> 5 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: No mortality or clinical signs were reported.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
NOEL > 5000 mg/kg bw/day (actual dose received)
Executive summary:

The toxicity of the substance after repeated dose was evaluated. For this reason the substance was orally admnistered to ten male rats for 5 concecutive days at doses of 50, 500 and 5000 mg/kg bw/day.

No mortality or clinical signs were reported.

NOEL > 5000 mg/kg bw/day (actual dose received)