Sodium 3-(allyloxy)-2-hydroxypropanesulphonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14. November 2012 - 18. december 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

GLP compliance:

yes (incl. QA statement)

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 - liquid: aqueous solution

Details on test material:

light yellow liquid

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Species fresh bovine corneas
Origin
Fresh bovine eyes were obtained from the slaughterhouse on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank’s balanced salt solu-tion (supplemented with 0.01% streptomycin and 0.01% penicillin). Then the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 hour.

Test system

Controls:

yes, concurrent positive control

yes, concurrent negative control

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

Post incubation: 2 hours at 32 °C.

Number of animals or in vitro replicates:

For each treatment group (negative control, positive control and test item), three replicates were used.

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

150.3

Negative controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Opacity and Permeability Values

The absorption (570 nm) and opacity values which were measured before and after exposition are given in the following table:

Absorption and Opacity Values Negative Control

Parameter	Negative Control
Absorption before exposition	0.1826	0.1843	0.1736
Absorption after exposition	0.2772	0.2472	0.1824
Opacity before exposition	1.5226	1.5286	1.4914
Opacity after exposition	1.8932	1.7669	1.5219
Opacity difference	0.3706	0.2382	0.0305

 

Mean opacity difference of the negative control is 0.2131.

Absorption and Opacity Values Test Item and Positive Control

Parameter	Test Itemsodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS)			Positive Control
Absorption before exposition	0.1623	0.1618	0.2444	0.1792	0.2138	0.1321
Absorption after exposition	2.0500	2.1496	2.1244	2.2342	1.9648	2.1006
Opacity before exposition	1.4531	1.4514	1.7555	1.5108	1.6361	1.3555
Opacity after exposition	112.2018	141.1237	133.1680	171.4747	92.2147	126.0666
Opacity difference	110.7487	139.6723	131.4125	169.9639	90.5786	124.7111

 

For the permeability measurement, three replicates for each treatment group were measured. The optical density values at 490 nm are given in the following table:

Optical density at 490 nm

Repl.	Negative Control			Test Itemsodium 3-(allyl­oxy)-2-hydroxypropane­sulphonate (HAPS)			Positive Control
Meas.	0.0101	0.0106	0.0059	0.3672	0.2928	0.2957	0.3771	0.3820	0.3852
Corr.	0.0505	0.0530	0.0295	1.8360	1.4640	1.4785	1.8855	1.9100	1.9260
Mean	0.0443			--

*In order to correct the path length, a factor of 5 was taken into account when calculating the IVIS

 IVIS Values

The calculated IVIS for each replicate and the corresponding means are presented in the following table:

IVIS

Test Group	IVIS	Mean IVIS	Relative Standard Deviation IVIS
Negative Control 0.9% NaCl	1.128	0.878	40.3%
	1.033
	0.473
Test Item	137.411	150.293	7.9%
	160.755
	152.712
Positive Control 10% NaOH	197.369	156.148	25.4%
	118.351
	152.723

This in vitro study was performed to assess the corneal irritation and damage potential of sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) by quantitative measurements of changes in opacity and permeability in a bovine cornea.

The test itemsodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS)was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32±1 °C for one hour and whose opacity had been determined. The test item was incubated on the cornea for 10 minutesat32±1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.

Physiological sodium chloride solution was used as negative control, sodium hydroxide (10% solution in 0.9% sodium chloride solution) was used as positive control.

The positive control induced a very severe irritation on the cornea, mean IVIS was 156.148.

The negative control showed no irritation, mean IVIS was 0.878.

The test item was tested pure. A mean IVIS of 150.293 was calculated, corresponding to an ICCVAM classification as very severely eye irritant. According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant. Therefore,sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) is classified as “corrosive” and/or “eye irritant”.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.

Applicant's summary and conclusion

Interpretation of results:

highly irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant. Substances with IVIS < 55.1 may be considered as non-corrosive resp. not severely irritant.
In the negative control, no signs of eye irritation were observed.
The positive control showed very severe eye irritation.
The test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) showed very severe eye irritation.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test itemsodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) possesses very severe eye irritation potential (according to ICCVAM).
According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.
Therefore, according to OECD, sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS)is classified as “corrosive” and/or “severe irritant”.

Executive summary:

One valid experiment was performed.

Bovine corneas were used. They were collected from slaughtered cattle which were between 12 and 60 months old.

Sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) was brought onto the cornea of a bovine eye which had been incubated with cMEM without phenol red at 32±1 °C for one hour and whose opacity had been measured. The test item was incubated on the cornea for 10 minutes at 32±1 °C. After removal of the test item and two hours post-incubation, opacity and permeability values were measured.

Physiological sodium chloride solution was used as negative control. The negative control showed no irritating effect on the cornea.

10% sodium hydroxide solution was used as positive control. The positive control induced a severe irritation on the cornea.

The test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) showed very severe effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 150.293.

In conclusion, it can be stated that in this study and under the experimental conditions reported, the test item sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) possesses very severe eye irritation potential (according to ICCVAM).

According to OECD Guideline no. 437 (2009), a substance that induces an IVIS ≥ 55.1 is defined as a corrosive or severe irritant.

Therefore, according to OECD,sodium 3-(allyloxy)-2-hydroxypropanesulphonate (HAPS) is classified as “corrosive” and/or “severe irritant”.