Disodium hydroxy(sulfonato)acetate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 18, 2009 - June 10, 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed in compliance with: "Chemikaliengesetz", dated July 25, 1994 and "OECD Principles of Good Laboratory Practice", as revised in 1997

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

none

Test animals / tissue source

Species:

other: Lohmann selected Leghorn chicken eggs

Strain:

not specified

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: other: Eggs treated with each 300 μL physiological NaCl solution (0.9% (v/v)) without other substanc es) were used as negative controls. 3 eggs were tested.

Duration of treatment / exposure:

The eggs were obtained from the LSL Rhein-Main Geflügelvermehrungsbetriebe (D-64807 Dieburg,
Germany) on day one. Afterwards they were incubated at 37,5 ± 0.5 °C for eight days. While incuba
tion the eggs were rotated to prevent an attachment of the embryo to one side of the egg. On day ei
ght the eggs were candled and non-viable eggs were discarded. The rest of the eggs were placed
upward in the incubator and were incubated for another day without rotation.

Observation period (in vivo):

The observation time was 300 s at room temperature.

Number of animals or in vitro replicates:

6 eggs

Results and discussion

In vitro

Results

Irritation parameter:

other: Mean irritancy index

Run / experiment:

1 to 6

Value:

0.66

Remarks on result:

no indication of irritation

Remarks:

Values <0.9 are related to the outcome "non irritant"

Any other information on results incl. tables

The solid test item was tested non dissolved. Therefore each about 100 mg of the test item was applied to the membrane so that at least 50% of the membrane was covered by the test item. During the observation for 300 seconds lesions in close proximity to the covered membrane were noted.

Physiological sodium chloride solution was used as negative control.The negative control showed no irritating effect on the blood vessels under the membrane.An 1% solution of SDS and 0.1 N solution of NaOH were used as positive controls.

The positive controls induced a severe irritation on the blood vessels. The calculated mean irritancy indices are 10.11 for 1% SDS and 18.85 for 0.1 N NaOH.

No irritating effects were observed during 5 min incubation with the test item. The calculated irritancy mean index is 0.66.

Test Group	Time until Haemorrhage [s]	Time until Lysis [s]	Time until Coagulation [s]	Irritancy Index	Mean Irritancy Index
Negative Control	301	301	301	0.00	0.00
Negative Control	301	301	301	0.00
Negative Control	301	301	301	0.00
Positive Control 0.1 N NaOH	11	66	11	19.02	18.85
Positive Control 0.1	8	79	13	18.70
Positive Control 0.1	8	75	12	18.83
Positive Control 1% SDS	18	63	301	10.27	10.11
Positive Control 1% SDS	23	73	301	9.95
Positive Control 1% SDS	20	69	301	10.10
Test Item	301	301	301	0,00	0.66
Test Item	301	301	301	0,00
Test Item	301	301	301	0,00
Test Item	301	301	301	0,00
Test Item	180	301	301	2,02
Test Item	185	301	301	1,93

CAMMean Irritancy Index	Evaluation
0 – 0.9	Non irritant
1 – 4.9	Slight irritant
5 – 8.9	Moderate irritant
9 - 21	Severe irritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item does not possess an irritating potential.

Executive summary:

The test did not reveal any irritant properties. Thus it is evident, that disodium hydroxy(sulfinato)acetate

is devoid of adverse reactivity towards mucous membranes.