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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Mar 12 - Apr 09, 1997
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
None
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Strain: Albino rabbit, Crl:KBL(NZW), female (f) Source: Charles River Wiga GmbH, KifßleggAge: about 27 weeksInitial Weight: 3,66 kg 3 female rabbits

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: aqua pro injectione
Amount / concentration applied:
0,5 g
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48, 72 hours after removal of patches and then daily up to day 8
Number of animals:
3 (f)
Details on study design:
Identification and adaptationThe animal was kept in the experimental room for more than 7 days to allow them to acclimatize.The animal was uniquely identified by a tattoo in the ear displaying the animal number. An individual cage card was affixed to the cage displaying the study number, test material, day of treatment, and animal number.AssignmentOne female rabbit, with the animal number 23, was used for this study. The initial body weight at the start of the experimental part was 3.98 kg. Housing and dietThe rabbit was housed in an air-conditioned room of about 28 m^2 in the Institute of Toxicology. Lighting was controlled by a timer to provide a 12-hour light and a 12-hour dark regime. They were kept separately in special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm^2, a shelter with an integrated sitting board of about 1820 cm^2; overall height: 60 cm) with plastic grids placed on mobile racks. The collection pans underneath the cages were cleaned at least three times a week. The cages were cleaned before the start of the study. Temperature and relative humidity were measured using a thermohygrograph. The room temperature varied from 16 to 18°C and the relative humidity from 47 to 67 %. The rabbit received a commercial diet for rabbits, Altromin Standard Diet ad libitum and fresh tap water from Makrolon drinking bottles ad libitum. According to the specifications given by the manufacturer, the diet had been checked by independent laboratories. Analysis included both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics. The drinking water was periodically analyzed according to the German regulations for human drinking water.Observations for clinical symptomsThe rabbit was examined for skin alterations, behavior, and general condition 1 hour after removal of the patch, after 24, 48, 72 hours, and then daily up to experimental day 8.Skin changes at the application sites were evaluated according to the DRAIZE-, OECD-and EEC recommendations.Grading scale for evaluation: Erythema and eschar formation Scores--------------------------------------------------No erythema 0Very slight erythema (barely perceptible) 1Well defined erythema 2Moderate to severe erythema 3 Severe erythema (beet redness) to eschar formation preventing grading of erythema 4--------------------------------------------------Maximum possible: 4--------------------------------------------------Edema formation Scores--------------------------------------------------No edema 0Very slight edema (barely perceptible) 1Slight edema (edges of area well defined by definite raising) 2Moderate edema (raised approx. 1 mm) 3 Severe edema (raised more than 1 mm and extending beyond area of exposure) 4--------------------------------------------------Maximum possible: 4--------------------------------------------------Total possible irritation score (maximum): 8Mean score = Mean grading for erythema or edema of all the rabbits per time pointMean cumulative score = Mean grading of all readings for erythema and edema per time pointMean score per animal = Mean grading for each animal of erythema or edema (24, 48, and 72 hours after removal of the patches)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0

Any other information on results incl. tables

0.5 g of the test material was administered. After a single application to the intact dorsal skin of a rabbit, for 4 hours under semiocclusive conditions, no signs of irritation were observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated informationCriteria used for interpretation of results: other: CLP
Conclusions:
According to EU Regulation No. 1272/2008 and CLP the test material must not be classified as an irritant to the skin.
Executive summary:

Purpose

The purpose of this assay was to identify the skin irritation/corrosion potential of the test material when applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions.

This study should provide a rational basis for risk assessment to the irritating potential of the test item in man.

Study Design

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of three previously shaven rabbits for a 4 hours period under semiocclusive conditions.

The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for another 7 days.

Results

No signs of irritation were observed after administration.

Day 1(1 hour)   2(24 hours) 3(48 hours)  7(72 hours) 
 edema  0 0
 erythma  0

Conclusion

According to EU Regulation No. 1272/2008 and CLP the test material must not be classified as an irritant to the skin.