Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08.11.2010-13.12.2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: A guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2011

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
Details on test material:
- Name of test material (as cited in study report): Sodium diacetate
- Lot/batch No.:1000022891

Test animals / tissue source

Species:
rabbit

Test system

Controls:
other: the non treatyed eye
Amount / concentration applied:
0.1g
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 96h
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 21
Score:
2
Max. score:
2
Reversibility:
not fully reversible within: 21 days
Remarks on result:
other: redness remained on day 21 in two anomals
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 5-7 days
Remarks on result:
other: congestion noted 1 hour after the test item instillation, totally reversible in 5-7 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium diacetae is irritating for eyes, causes irreversible effects on the eyes.
Executive summary:

The results of the study of eye irritation (according to OECD 405 guideline) shows that Sodium diacetae is irritating for eyes, causing irreversible effects on the eyes. The substance is classified as Causing Irreversible Effects for Eyes: Category 1.