Registration Dossier

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:
other: OECD 438
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

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

categories1

Irritation

Index2

Classifi­ca­tion

(EC-GHS3)

Swelling %

Opacity

Fluorescein

retention

Sodiumsesquicarbonate

4

1.0

1.3

I;II;II

50

NC/NI

NaOH

(positive control)

42

4.04

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.