Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

single oral administration

GLP compliance:

no

Remarks:

Study conducted in 1987, before 1 June 2008 (refering to REACH Article 13(4))

Test material

Test material information

Constituent 1

Reference substance name:

Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt

EC Number:

241-253-9

EC Name:

Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt

Cas Number:

17211-15-3

IUPAC Name:

Esters of sodium phosphate with myo-Inositol, plant-derived (old IUPAC name: dodecasodium;(2,3,4,5,6-pentaphosphonatooxycyclohexyl) phosphate)

Test material form:

solid: bulk

Details on test material:

According to the authors of the study the water content of the test item was 11%.

Specific details on test material used for the study:

The study was performed on dodecasodium phyate (C6H6(PO3Na2)6 x H2O with a water content of 11%) which is equivalent to the substance "Esters of sodium phosphate with myo-Inositol, plant-derived (old name: Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt, CAS 17211 -15 -3).

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:: Sodium Phytate from NAKARAI CHEMICALS, LTD. (Reagent first grade, Lot No. M6H 2435, C6H6(PO3Na2)6 x H2O, Water content 11%)

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Sample was diluted or dissolved with purified water. For details on volumes (ml/kg bw) & doses (g/kg bw) refer to Table in section "Any other information on materials and methods incl. tables".

Test animals

Species:

rat

Strain:

Fischer 344/DuCrj

Sex:

male/female

Administration / exposure

Vehicle:

water

Doses:

Experiment 3: 0.61 / 0.91 / 1.35 / 2.03 / 3.04 g/kg bw (Volume 0.8 ml/kg bw)
Experiment 4: 0.94 / 1.03 / 1.14 / 1.25 / 1.38 / 1.51 g/kg bw (Volume 0.5 ml/kg bw)

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

Experiment 3: Moving Avergae method
Experiment 4: Lichtfield-Wilcoxon

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

1.13 other: g/kg bw

Based on:

test mat.

95% CL:

>= 0.935 - <= 1.365

Remarks on result:

other: Experiment 3

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

1.672 other: g/kg bw

Based on:

test mat.

Remarks on result:

other: Experiment 3

Remarks:

by Moving Avergae method

Effect levels 3

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1.03 other: g/kg bw

Based on:

test mat.

95% CL:

>= 0.95 - <= 1.117

Remarks on result:

other: Experiment 4

Effect levels 4

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

1.2 other: g/kg bw

Based on:

test mat.

95% CL:

>= 0.668 - <= 2.156

Remarks on result:

other: Experiment 4

Mortality:

Experiment 4:
- Most of deaths occurred ≤24 h after administration
- male: onset after 3h / peak after 7h / last after 24h
- female: onset after 3h / peak after 5h / last after 46h

Clinical signs:

other: Marked expansion of the stomach and bleeding of the glandular portion of the stomach were seen. The color of liver and spleen was turned dark red. The color of the duodenum, ileum and jejunum was turned dark or black due to bleeding or bodily fluid contai

Any other information on results incl. tables

Table: LD50 of sodium phytate in rats

Material	Exp. No.	Sex	Death Time (hr.)	Slope Function (Confidence Interval at p = 0.05)	LD50 (g/kg) (Confidence Interval at p = 0.05)
Sodium phytate (C6H6(PO3Na2)6* xH2O)	3	M		1.241 (0.874 ~ 1.763)	1.13 (0.935 ~ 1.365)
		F			1.672 (-)
	4	M	3 (onset)  7 (peak) 24 (last)	1.119 (1.018 ~ 1.230)	1.03 (0.950 ~ 1.117)
		F	3 (onset) 5 (peak) 46 (last)	1.180 (0.594 ~ 2.346)	1.20 (0.668 ~ 2.156)

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 values for acute toxicity (oral) in rats (Fischer 344/DuCrj) of the test item were reported to be 1200 mg/kg bw (female) and 1030 mg/kg bw (male). [Exp. 4]

Executive summary:

A single oral administration to rats (Fischer 344/DuCrj) was followed by a 7 -day observation period. Rats were dosed between 940 - 1510 mg/kg body weight with in total 6 different doses (Experiment 4). Most of the deaths in male and female rats occured ≤ 24 h after administration in the treated animals. For male rats the onset was after 3 h, the peak of deaths was reached after 7 h and the last death occured after 24 h. For female rats the onset was also after 3h, the peak of deaths was already reached after 5 h and the last death occured after 46 h. Observed clinical signs of treated animals comprised marked expansion of the stomach and bleeding of the glandular portion of the stomach.

The oral LD50 values of the test item in rats were reported to be 1030 (males) and 1200 (females) mg/kg body weight.