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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

This endpoint study record is part of a Weight of Evidence approach comprising two published studies. The test item of this study was a sodium phytate (grade of neutralisation not specified) and the test item of the second published study (RL1) was an analogue substance ("Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt" (CAS 17211 -15 -3; EC 241 -253 -9)) with a similar structure and similar intrinsic properties (Read-across approach). For the justification of the Read-across approach, please refer to the analogue justification attached to IUCLID section 13.
Both data sources are in accordance with generally accepted scientific standards and were performed on different test animal species (mouse and rat). The derived results from the studies are comparable and are sufficient to fulfil the information requirements of this endpoint as further explained in the provided endpoint summary.

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 carried out 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), sodium salt

EC Number:

238-242-6

EC Name:

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

Cas Number:

14306-25-3

Molecular formula:

C6H18O24P6.xNa

IUPAC Name:

Esters of sodium hydrogen phosphate with myo-Inositol, plant-derived (old name: myo-Inositol, hexakis(dihydrogen phosphate), sodium salt)

Test material form:

solid - liquid: aqueous solution

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sodium Phytate from NAKARAI CHEMICALS, LTD. (unknown grade of neutralisation)
- Expiration date of the lot/batch: no data
- Purity test date: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Sample was water solution. For information on the applied doses (mg/kg B.W.) refer to Table 3 in section "Illustration (picture/graph)".

Test animals

Species:

mouse

Strain:

ICL-ICR

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Doses:

590 / 880 / 1320 / 1980 / 2970 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 48 hr
- Frequency of observations and weighing: 7 (no weighing)
- Other examinations performed: clinical signs

Statistics:

Lichtfield Wilcoxon

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

2 750 mg/kg bw

Based on:

test mat.

95% CL:

>= 1 990 - <= 3 800

Effect levels 2

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

1 030 mg/kg bw

Based on:

test mat.

95% CL:

>= 560 - <= 1 910

Mortality:

Male: At 2970 mg/kg bw two animals died in the first hour, one animal in the third and another animal in the fourth hour after dosing. At 1980 mg/kg bw 3 animals died in the first hour and one animal between 24 to 48h. At 1320 mg/kg bw 3 animals died in the first hour.No mortalities occurred at 880 mg/kg bw and lower.

Female: At 2970 mg/kg bw two animals died in the fiirst hour and one animal after 5 hours after dosing. At 1980 mg/kg bw one animal died in the first hour. No mortalities occurred at 1320 mg/kg bw and lower.

Clinical signs:

other: In the substance-treated animals the following clinical signs were observed: - Erosion of the stomach wall - bleeding of the glandular portion of the stomach - hypertrophy of the gallbladder - thinning of the small intestinal wall

Any other information on results incl. tables

		Lichtfield-Wilcoxon
	Dose Range (mg/kg bw)	LD50 (mg/kg bw)	Confidence limit (p = 0.05)
Male	590 - 2970	1030	560 - 1910
Female	590 - 2970	2750	1990 - 3800

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The LD50 values for acute toxicity (oral) in mice (ICL-ICR) of the test item were reported to be 2750 mg/kg bw (female) and 1030 mg/kg bw (male).

Executive summary:

A single oral administration to mice (ICL-ICR)with5 different doses between 590 - 2970 mg/kg body weight were conducted. Most of the deaths in male and female mice occured within 1h after administration.In male animals dosed at 2970 mg/kg body weight mortality occurred in 4 of 5 males in the first 4 hours after administration. At a dose of 1980 mg/kg bw 3 of 5 male mice died in the first hour and one animal between 24 to 48h after administration. At a dose of 1320 mg/kg bw 3 of 5 male animals died in the first hour. No mortalities occurred at a dose of 880 mg/kg bw and lower. In female mice at 2970 mg/kg bw mortality occured for 2 of 5 animals in the first hour and for one animal after 5 hours. At a dose of 1980 mg/kg bw 1 of 5 female mice died in the first hour. No mortalities among female mice occurred at a dose of 1320 mg/kg bw and lower. In the substance-treated animals erosion of the stomach wall, bleeding of the glandular portion of the stomach, hypertrophy of the gallbladder, and thinning of the intestinal wall were reported.

The oral LD50 values of this test item in mice (ICL-ICR) were reported to be 1030 (males) and 2750 (females) mg/kg body weight.