Trisodium hydrogendicarbonate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study conducted by GLP laboratory according to OECD guideline method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 438

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium hydrogendicarbonate

EC Number:

208-580-9

EC Name:

Trisodium hydrogendicarbonate

Cas Number:

533-96-0

Molecular formula:

CH2O3.3/2Na

IUPAC Name:

trisodium hydrogendicarbonate

Test animals / tissue source

Species:

other: chicken

Strain:

other: ROSS, spring chicken

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

30 mg

Duration of treatment / exposure:

10 seconds on 3 animals and 30 seconds on one

Observation period (in vivo):

4h

Number of animals or in vitro replicates:

4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Remarks:

2 Irritation Index = maximum mean corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20).

Basis:

mean

Time point:

other: 240 min

Score:

50

Reversibility:

not specified

Any other information on results incl. tables

 

 

Test material	Maximum mean score for:			Irritation categories^1	Irritation Index^2	Classifi­ca­tion (EC-GHS^3)
	Swelling %	Opacity	Fluorescein retention
Sodiumsesquicarbonate	4	1.0	1.3	I;II;II	50	NC/NI
NaOH (positive control)	42	4.0^4	3.0	IV;IV;IV	182	Category 1
Saline (negative control)^5	0	0.0	0.0	n.a.^6	n.a.	n.a.

       

1      I = no effect; II = slight effect; III = moderate effect; IV = severe effect.

2      Irritation Index = maximum mean corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20).

3  NC/NI = non- classified/non-irritant; Category 2 = Irritating to eyes; Category 1 = irreversible effects on the eye/serious damage to the eye. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

4      Immediate iris contraction

5      Individual values based on one eye.

6      n.a. = not applicable.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

non irritating

Executive summary:

1.     Sodiumsesquicarbonate was evaluated neat in the Isolated ChickenEye (ICE) test. Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of the test sample for 10 seconds using an application amount of 30 mg. Because the test substance, a powder, could adhere to the cornea, one additional test eye was treated for 30 seconds in order to mimic possible prolonged exposure (up to one hour) which may occur in thein vivorabbit eye irritation test with solids. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells.

2.     no corneal effects.

3.     caused severe swelling, very severe opacity and severe fluorescein retention. The calculated Irritation Index was 182.

4.     Sodiumsesquicarbonate caused very slight swelling, slight opacity and slight or slight to moderate fluorescein retention. The calculated Irritation Index was 50. Prolonged exposure slightly increased the corneal effectsbut they were still markedly below the threshold of severe irritancy.

5.     Sodiumsesquicarbonate is proposed to be non-classified/non-irritant.