Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
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 404 (Acute Dermal 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

Species:
rabbit

Test system

Duration of treatment / exposure:
4 hours
Observation period:
72 hours (after patch removal)
Number of animals:
3 animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1h
Score:
1
Max. score:
1
Remarks on result:
other: Only slight erythrema was observed in one animal
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72h
Score:
0
Max. score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sodium diacetate is not irritating for skin.
Executive summary:

In the study of skinn irritation (according to OECD 404 guideline) was demonstrated that Sodium diacetate is not irritating for skin.