Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 May 2016 -08 August 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
gender: male
age: 10-14 weeks
housing: temperature 17-23 degrees Celsius, humidity 30-70%, light/dark: 12h/12h
food/drink: ad libitum

Test system

Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The ocular reactions observed during the study have been slight and totally reversible:
caculated means:
cornea opacity: animal#1 0.0, animal #2 0.7, animal#3 0.3
iris lesion: animal#1 0.0, animal #2 0.7, animal#3 0.3
conjunctivae chemosis: animal#1 0.3, animal #2 1.0, animal#3 1.0
conjunctivae redness: animal#1 1.3, animal #2 1.0, animal#3 1.3

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results obtained enable to conclude that sodium propionate does not have to classified as corrosive/irritant to the eye.
No symbol and warning label are required.
Executive summary:

Sodium proopionate was supplied into the eye of 3 New Zealand rabbits at te dose of 0.1g. The experimental protocol was based on OECD TG 405.

The results obtained enable to conclude that sodium propionate does not have to be classified as corrosive/irritant to the eye .

No symbol and warning label are required.