Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
guinea pig
Strain:
Hartley

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
A dose of 0.5 mL was applied to each depilated guinea pig abdomen.
Duration of treatment / exposure:
An occlusive wrap was used to hold the test material against the skin for 24 hours.
Observation period:
14 days
Number of animals:
5

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: The score was not counted. The results were evalauted based on as slight, moderate and stong efefct levels
Irritation parameter:
edema score
Time point:
24/48/72 h
Score:
0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Sucrose Acetate Isobutyrate (SAIB) is non-irritating to guinea pig skin.
Executive summary:

A dose of 0.5 mL of Sucrose Acetate Isobutyrate (SAIB) was applied to each depilated abdomen of 5 guinea pigs, and an occlusive wrap was used to hold the test material against the skin for 24 hours. No signs of irritation were observed over the 14-day observation period. All animals gained weight normally, and based on weight gain and survival rate, no signs of percutaneous absorption were evident.