Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 July 2012 - 13. September 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

EC Number:

258-004-5

EC Name:

Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

Cas Number:

52556-42-0

Molecular formula:

C6H12O5S.Na

IUPAC Name:

sodium 2-hydroxy-3-(prop-2-en-1-yloxy)propane-1-sulfonate

additive 1

Reference substance name:

Sodium hydroxide

EC Number:

215-185-5

EC Name:

Sodium hydroxide

Cas Number:

1310-73-2

Molecular formula:

HNaO

IUPAC Name:

sodium hydroxide

impurity 1

Reference substance name:

3-(allyloxy)propane-1,2-diol

EC Number:

204-620-4

EC Name:

3-(allyloxy)propane-1,2-diol

Cas Number:

123-34-2

Molecular formula:

C6H12O3

IUPAC Name:

3-(allyloxy)propane-1,2-diol

impurity 2

Reference substance name:

disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate

Molecular formula:

C6H12Na2O8S2

IUPAC Name:

disodium 2-hydroxy-3-(3-sulfonatopropoxy)propane-1-sulfonate

Test material form:

solid: particulate/powder

Details on test material:

light yellow powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Environmental conditions
Healthy femal rats were housed by group of three in solid bottomed clear polycarbonates cages.
Temperature 19 - 25° C
Relative humidity 30 - 70 %

Food and drinking
Drinking water and foodstuff were supplied freely. Food was removed on D-1 and then redistributed 4 hours after the test item administration.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Doses:

300 mg/kg bw/day and 2000 mg/kg bw/day

No. of animals per sex per dose:

6 rats (female) per dose

Control animals:

no

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No mortality occured in animals dosed at 300 mg/kg bw and 2000 mg/kg bw.

Clinical signs:

other: Dose: 300 mg/kg bw No clinical signs related to the adminsitration of the test item were observed during the study. Dose: 2000 mg/kg bw A decrease in spontaneous activity (3/) and piloerection (3/6) were noted at 1 hour post-dose.

Gross pathology:

The macroscopic examination of the animal at the end of the study did not reveal treatment related changes.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD 50 of the test item is higer than 2000 mg/kg body weight by oral route in the rat.
In accordance with the OECD guideline No. 423, the LD50 cut off-of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.
According to the criteria of classification , packaging and labelling of dangerous substances and preparation in accordance with the ECC Directives 67/548, 2001/59 and 99/45, the test item does not have to be classified. No symbol or risk phrase is required.
In accordance with the regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item does not have to be classified. No signal word or hazard satement is requird.

Executive summary:

The test item was administrated to a group of 6 female Sprague Dawley rats at a single dose of 300 mg/kg body weight ans then, to a group of 6 female sprague Dawley rats at the single dose of 2000 mg/kg body weight. The experimental protocol was established according to the official method as defined in the OECD guideline No. 423 dated December 17th, 2001 and the test method B.1 tris of the council regulation No. 440/2008.

No mortality occured in animals dosed at 300 mg/kg body weight.

No clinical signs related to the adminsitration of the test item were observed during the study.

No body weight evolution of hte animal remained normal throughout the study.

The macroscopic examination of the animal at the end of the study did not reveal treatment related changes.

No mortality occured in animals dosed at 2000 mg/kg body weight.

A decrease in spontaneous activity (3/) and piloerection (3/6) were noted at 1 hour post-dose.

No body weight evolution of hte animal remained normal throughout the study.

The macroscopic examination of the animal at the end of the study did not reveal treatment related changes.

In conclusion, the LD 50 of the test item is higer than 2000 mg/kg body weight by oral route in the rat.

In accordance with the OECD guideline No. 423, the LD50 cut off-of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.

According to the criteria of classification , packaging and labelling of dangerous substances and preparation in accordance with the ECC Directives 67/548, 2001/59 and 99/45, the test item does not have to be classified. No symbol or risk phrase is required.

In accordance with the regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item does not have to be classified. No signal word or hazard satement is requird.