Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
14-AUG-2001 to 19-SEP-2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study has been performed in compliance with the Swiss Ordinance relating to Good Laboratory Practice, adopted February 2nd, 2000 [RS 813.01 6.51. This Ordinance is based on the OECD Principles of Good Laboratory Practice, as revised in 1997 and adopted November 26th, 1997 by decision of the OECD Council [C(97)186/Final]. These procedures were consistent with Good Laboratory Practice regulations specified by regulatory authorities throughout the European Community, the United States (EPA and FDA), and Japan (MHW, MAFF and MITI).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Description: white powder
Stability of test item Stable under storage conditions
Expiry date 08- J U N-2002
Storage conditions: In the original container, in the refrigerator (range of 2-8 OC), away from direct sunlight. The container was purged with nitrogen after use.
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with an electric clipper
Vehicle:
water
Controls:
other: untreated unclipped right flank of the test animal
Duration of treatment / exposure:
four hours
Observation period:
The skin reactions (erythema and eschar, as well as oedema formation) were evaluated at 1, 24, 48 and 72 hours after removal of the dressing and test item.
Number of animals:
three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
other: 1 to 72 hours
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
three animals
Time point:
other: 1 to 72 hours
Score:
0

Any other information on results incl. tables

VIABILITY/MORTALITY/CLINICAL SIGNS

No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

 

IRRITATION

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores0).The individual mean score for erythema/eschar and oedema for each of the three animals was therefore0.

 

COLORATION

No staining by the test item on the treated skin was observed.

 

CORROSION

Noirreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

 

BODY WEIGHTS

The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the referred classification criteria (EEC Commission Directive 93/21/EEC of
April 27, 1993), ACETYLFURANOSIDE is considered to be “not irritating” to rabbit skin.
Executive summary:

To assess the primary skin irritation potential of ACETYLFURANOSIDE, a primary skin irritation study was performed in three (one male and two females) young adult New Zealand White rabbits.

 

The fur of the left flank was clipped and 0.5 g of ACETYLFURANOSIDE was applied epicutaneously to an area of approximately 6 cm2and then covered with a semi-occlusive dressing for approximately four hours. The skin reactions (erythema and eschar, as well as oedema formation) were evaluated at 1, 24, 48 and 72 hours after removal of the dressing and test item.

 

The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

 

The test item caused no staining of the treated skin.

 

No corrosive effects were noted on the treated skin of any animal at any measuring interval.

 

Following evaluation of the experimental data according to the EEC classification criteria, ACETYLFURANOSIDE is classified as "not irritating" to rabbit skin.