Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Remarks:
Maximum non-lethal dose
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Acute toxicity studies:

Acute oral toxicity investigations in rats
(Charles River CD strain for the substance, AHH-R
or AP1-R strains) were undertaken by determining the
range in which the maximum non-lethal dose (MNLD)
occurred.

A dose-range finding study with two rats per sex
per group examined doses of 25, 200, 1000, 2000
or 5000 mg/kg bodyweight: the highest dose was
only administered if no significant changes were
seen at lower doses after two hours. Mortalities
and clinical signs were recorded for 14 days. A
confirmatory study, with a 14 day observation
period, using five rats per sex examined the MNLD
determined by the range-finder.
GLP compliance:
not specified
Test type:
other:

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
other:
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Doses:
25, 200, 1000, 2000
or 5000 mg/kg bodyweight: the highest dose was
only administered if no significant changes were
seen at lower doses after two hours
No. of animals per sex per dose:
2
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 - < 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
Based on the available information the substance is not classified for acute oral toxicity.
Executive summary:

Acute toxicity studies: Acute oral toxicity investigations in rats (Charles River CD strain for the substance, AHH-R or AP1-R strains) were undertaken by determining the range in which the maximum non-lethal dose (MNLD) occurred. A dose-range finding study with two rats per sex per group examined doses of 25, 200, 1000, 2000 or 5000 mg/kg bodyweight: the highest dose was only administered if no significant changes were seen at lower doses after two hours. Mortalities and clinical signs were recorded for 14 days. A confirmatory study, with a 14 day observation period, using five rats per sex examined the MNLD determined by the range-finder.

Maximum non-lethal dose is between 2000 and 5000 mg/kg.

Based on the available information the substance is not classified for acute oral toxicity.