Trisodium hydrogen diphosphate

Acute Toxicity: other routes

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

Test material information

Constituent 1

Reference substance name:

Tetrasodium pyrophosphate

EC Number:

231-767-1

EC Name:

Tetrasodium pyrophosphate

Cas Number:

7722-88-5

Molecular formula:

Na4P2O7

IUPAC Name:

tetrasodium phosphonato phosphate

Test material form:

not specified

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 or test system 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.