Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May 25, 2000 - Jun 01, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to Good Laboratory Practice (GLP) and followed the OECD Guideline for Testing of Chemicals No 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: CCP-V-1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Strain: Albino rabbit, Crl:KBL(NZW)BR, female (f)
Source: Charles River Wiga GmbH, Kif3legg
Age: about 33 weeks
Weight: 4,31 kg (3,77-4,76)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0,5 g CCP-V-1
Duration of treatment / exposure:
4 hours
Observation period:
24, 48, 72 hours after removal of patches
Number of animals:
3 female rabbits
Details on study design:
Identification and adaptation
Healthy rabbits were allocated to the study group. The animals were kept in the experimental room for more than 7 days to allow for acclimatization.
Each animal was uniquely identified by a tattoo in the ear displaying the animal number. Individual cage cards were affixed to each cage displaying the study number, test material, day of treatment, and animal number.

Assignment
3 female rabbits were used for this study with the animal Nos. 4, 6, and 10. The mean initial body weight at the start of the study was 4.31 kg (range from 3.77 to 4.76).

Housing and diet
All rabbits were housed in an air-conditioned room of about 28 m^2. 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 20 to 22°C and the relative humidity from 50 to 64 %.
The rabbits received diet for rabbits No. 814, Eberle Nafag ad libitum, and fresh tap water from Makrolon drinking bottles at least three times a week.
The diet is checked periodically according to the specifications of the manufacturer by an independent laboratory, approved by the government. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
The drinking water is periodically analyzed according to the regulations for human drinking water.

Vehicle
Aqua pro injectione

Grading scale for evaluation:

Erythema and eschar formation

Scores
--------------------------------------------------
No erythema 0

Very slight erythema (barely perceptible) 1

Well defined erythema 2

Moderate to severe erythema 3

Severe erythema (beet redness) to eschar
formation preventing grading of erythema 4
--------------------------------------------------
Maximum possible: 4
--------------------------------------------------

Edema formation
Scores
--------------------------------------------------
No edema 0

Very slight edema (barely perceptible) 1

Slight edema (edges of area well
defined by definite raising) 2

Moderate 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): 8

Mean score = Mean grading for erythema or edema of all the rabbits per time point
Mean cumulative score = Mean grading of all readings for erythema and edema per time point
Mean 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

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h, 24 h, 48 h, 72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Irritant / corrosive response data:
After a single application to the intact dorsal skin of rabbits, for a 4 hours period of exposure under semiocclusive conditions, no signs of irritation were observed in the treated areas.
Other effects:
None

Any other information on results incl. tables

Clinical findings

After a single application to the intact dorsal skin of rabbits, for a 4 hours period of exposure under semiocclusive conditions, no signs of irritation were observed in the treated areas. No signs of clinical toxicity were detected.

Mortality

All animals survived the observation period.

Body weight

Body weight development of the treated rabbits was inconspicuous.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item CCP-V-1 was not irritating to the skin in this assay. According to the Regulation (EC) No 1272/2008, OJ L 353 the test material should not be classified as a skin irritant.
Executive summary:

Purpose

The purpose of this assay was to identify the skin irritation/corrosion potential of the test item 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, CCP-V-1 was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto 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. Then, examinations were performed daily for further 7 days.

Results

Under the conditions of the present study no signs of irritation were seen. The evaluation of all animals yields a zero mean score.

Conclusion

The test item CCP-V-1 was not irritating to the skin in this assay. According to the EEC-Directive 2001/59 the test material should not be classified as a skin irritant.