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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
No detail included in methodology and results. All studies included in the report are brief summaries. The test method is not described and the results are only briefly summarised. This study is not considered to be sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 and therefore the study cannot be assigned as reliable for use as a key study, however the data is acceptable for use as part of a weight of evidence approach (as detailed in Annex XI, Section 1.2 of Regulation (EC) No. 1907/2006).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No details on methodology included within study report. 14 day acute toxicity screening study.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : Tetrapotassium pyrophosphate
- Analytical purity: No data

Test animals

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

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
No data
Doses:
1000 and 4640 mg/kg
No. of animals per sex per dose:
4 animals per dose group
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 1 000 mg/kg bw
Mortality:
All 4 animals from the 4640 mg/kg dose group were recorded dead at 18 hours post dosing. No unscheduled deaths were recorded in the 1000 mg/kg dose group.
Clinical signs:
Acute depression and pain reaction was recorded in the 4640 mg/kg dose group.
Body weight:
No data
Gross pathology:
At autopsy, corrosion of the gastrointestinal tract was noted.
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
other: Not specified
Remarks:
Criteria used for interpretation of results: not specified
Conclusions:
The acute oral LD50 for tetrapotassium pyrophosphate in male rats was determined to be > 1000 mg/kg. This study is not considered to be sufficient for classification and labelling in accordance with Regulation (EC) No. 1272/2008 and therefore the study cannot be assigned as reliable for use as a key study, however the data is acceptable for use as part of a weight of evidence approach (as detailed in Annex XI, Section 1.2 of Regulation (EC) No. 1907/2006).