Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study conducted prior to the introduction of GLP and OECD test guidelines. Standard methods used but details of methods and results not available. For read-across justification see Section 13.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats given single doses of DUP of up to at least 15, 800 mg/kg bw. Animals observed for signs of toxicity.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
No data

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
No data
Doses:
Up to at least 15,800 mg/kg bw
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
No data
Statistics:
No data

Results and discussion

Preliminary study:
No data
Effect levels
Sex:
not specified
Dose descriptor:
other: minimum lethal dose
Effect level:
> 15.8 other: g/kg bw
Based on:
test mat.
Remarks on result:
other: No 95% confidence limits reported
Mortality:
No mortality
Clinical signs:
No significant toxic effects
Body weight:
No significant toxic effects
Gross pathology:
No significant toxic effects
Other findings:
None reported

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study DUP is virtually non-toxic
Executive summary:

The acute oral toxicity (LD50) of the substance in the rat is in excess of 15.8 g/kg body weight