Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Follows a methodology which is comparable in part with standard guidelines, does not have GLP. This result was obtained by valid read-across.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
In a non-standard study, unspecified groups of rats and mice were treated by intraperitoneal route for 10 successive days.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other:
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
Once daily
Frequency of treatment:
10 days
Doses / concentrations
Remarks:
Doses / Concentrations:
250 mg/kg/day, 500 mg/kg/day, 1000 mg/kg/day, 2000 mg/kg/day
Control animals:
yes, concurrent no treatment
Details on study design:
Post observation period: 10 days where animals were observed for clinical signs.

Examinations

Observations and examinations performed and frequency:
Groups of rats and mice were exposed to a single oral dose by the intraperitoneal route over a ten day period. The dose groups comprised 250 mg/kg/day, 500 mg/kg/day, 1000mg/kg/day and 2000 mg/kg/day respectively, and included a control group.

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
250 mg/kg bw (total dose)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: no data

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No reporting on clinical observations was provided in the original study. The results gave a NOAEL = 250 mg/kg (bw) via the intraperitoneal route for both the rat and mice.