Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1973
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1973
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
See read-across justification in section 13.2
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not specified.
GLP compliance:
no
Remarks:
Test carried out prior to GLP.
Test type:
fixed dose procedure
Limit test:
yes
Test material information:
Composition 1
Species:
other: not specified
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified
Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
not specified
No. of animals per sex per dose:
10
Control animals:
no
Preliminary study:
none
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
None observed
Body weight:
None observed
Gross pathology:
None observed
Other findings:
see attachment.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance tested has an acute oral LD50 of > 5.0 g/kg.

Data source

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

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Not specified.
GLP compliance:
no
Remarks:
Test carried out prior to GLP.
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: not specified
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
not specified

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
not specified
Details on oral exposure:
not specified
Doses:
not specified
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Preliminary study:
none
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality observed
Clinical signs:
None observed
Body weight:
None observed
Gross pathology:
None observed
Other findings:
see attachment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance tested has an acute oral LD50 of > 5.0 g/kg.