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: OECD guideline and EU method. GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Physical state: White powder
- Analytical purity: 100%
- Lot/batch No.: I10110E
- Storage condition of test material: Room temperature, in the dark.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Leicestershire, UK
- Age at study initiation: Approximately 12 - 20 weeks at the start of treatment
- Weight at study initiation: 2.49-3.14 kg
- Housing: lndividually housed in suspended metal and/or plastic cages.
- Diet (e.g. ad libitum): 2930 Teklad Global Certified Diet, at libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 ºC
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours of continuous artificial light in each twenty-four hour period

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: On the day before treatment the back and flanks of each animal will be clipped free of fur using veterinary clippers.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened sufficiently with 0.5 ml of distilled water to achieve a paste.
Duration of treatment / exposure:
Animal 1: 3 minutes, 1 hour and 4 hours
Animal 2: 4 hours
Observation period:
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation.
Number of animals:
Two animals
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: The test item will be applied to a small area of skin (approximately 6 cm2) under a cotton gauze patch (2.5 cm x 2.5 cm). The patch will be secured to the skin using a single strip of surgical adhesive tape (approximate size 2.5 cm x 4.0 cm). To prevent interference with the patches and ingestion of the test item the animals will be fitted with an elasticated corset for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM:
Erythema and Eschar formation:
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4

Oedema Formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-72 h
Score:
0
Irritant / corrosive response data:
3-Minute Exposure Period
No evidence of skin irritation was noted during the study.
1-Hour Exposure Period
No evidence of skin irritation was noted during the study.
4-Hour Exposure Period
No evidence of skin irritation was noted during the study.
Other effects:
Both animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 1: Individual Skin Reactions Following 4-Hour Exposure

 

24 h

48 h

72 h

Mean 24-72 h

Animal No.

Animal No.

Animal No.

1

2

1

2

1

2

Erythema

0

0

0

0

0

0

0

Oedema

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with the following:

- OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 24 April 2002)

. Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008

3-minute and 1-hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.

A single 4-hour, semi-occluded application of the test item to the intact skin of two rabbits produced no evidence of skin irritation.

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.