Registration Dossier

Toxicological information

Acute Toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
acute toxicity: other routes
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: Early publication, well reported in contemporary style. This data is not considered to be relevant for risk assessment as the route of administration is not relevant to the work or consumer population.

Data source

Reference
Reference Type:
publication
Title:
Biological effects of food additives II - Sodium Pyrophosphate
Author:
Datta PK et al.
Year:
1962
Bibliographic source:
J.Sci. Food Agric, 1962, Vol 13, November

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Ten doses between 25 and 1000 mg/kg applied to 6 rats each, 4 doses used for LD 50 calculation. Observation period 10 days.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Sodium pyrophosphate: supplied by Messrs. Albright and Wilson as Tetron K, analysing as 97.5% sodium pyrophosphate and 2.5% orthophosphate.

Test animals

Species:
rat
Strain:
other: Birmingham Wistar
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Doses:
25, 40, 63, 100, 159, 251, 398, 631, 1000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 10 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 233 mg/kg bw
95% CL:
192 - 282
Mortality:
see table 1.

Any other information on results incl. tables

Table 1: Intraperitoneal dose levels of Na pyrophosphate
             and mortality

 Dose

mg/kg bw.

No of rats  No dying in 16 h 
 1000  6  6
 631  6  6
 398*  6  6
 251*  6  4
 159*  6  0
 100*  6  0
 63  2  0
 40  2  0
 25  2  0

* used for calculation of LD50

The LD50 was determined as 233 mg/kg bw with a confidence interval of 192 - 282 mg/kg bw.

Mortality at higher doses occurred within 2 hours, dying animals became gradually weaker and showed a gasping type respiration. At lower doses, rats died within 16 hours.

Necropsy of dying revealed slight redness of the serous surface of the small intestine and fluid in the peritoneal cavity. Surving rats had no gross findings after 10 days.

Applicant's summary and conclusion

Conclusions:
The intraperitoneal LD50 was determined as 233 mg/kg bw with a confidence interval of 192 - 282 mg/kg bw.