Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006-11-09 to 2007-04-11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion) without deviations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The testing facility indicated that the protocol was followed without deviation.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The testing facility indicated that the protocol was followed without deviation.
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. certificate)
Remarks:
Certificate from the Department of Health of the Government of the United Kingdom

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): VRT-126016
- Molecular formula: not applicable
- Molecular weight: not applicable
- Smiles notation: not applicable
- InChl: not applicable
- Structural formula attached as image file: not applicable
- Substance type: no data
- Physical state: white powder
- Analytical purity: 99.8 area %
- Impurities: 0.03 area % of unknowns
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: 2006-09-15
- Lot/batch No.: Batch number 0000025719/Lot No. 1-4107-6-02-02
- Expiration date of the lot/batch: 2008-02
- Stability under test conditions: no data
- Storage condition of test material: room temperature
- Other: no data

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: obtained from Harlan UK Ltd, Bicester, Oxon, England
- Age at study initiation: approximately 34 weeks of age, prior to treatment (Day 1)
- Weight at study initiation: 3.19 – 4.41 kg
- Housing: housed individually in plastic cages with perforated floors
- Diet: offered 125 g of a standard laboratory rabbit diet (Rabbit Diet Pellets (Teklad) supplied by Harlan UK Ltd.) per day
- Water: provided ad libitum
- Acclimation period: at least fourteen weeks prior to the start of the study

ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 16 to 20 deg C
- Humidity (%): 40 to 70%
- Air changes (per hr): not applicable
- Photoperiod (hrs dark / hrs light): Lighting was controlled by means of a time switch to give 12 hours of artificial light (06:00 to 18:00 GMT) in each 24 hour period.

IN-LIFE DATES
- From: 2006-11-28 to 2006-12-19

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
yes, concurrent vehicle
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): no data

VEHICLE
- Amount(s) applied (volume or weight with unit): no data
- Concentration (if solution): The treatment site was ‘wetted’ with 0.5mL of reverse osmosis water.
- Lot/batch no. (if required): no data
- Purity: no data
Duration of treatment / exposure:
single four hour dermal administration
Observation period:
Examination of the treated skin was made on removal of the dressings (for 3 minute or one hour exposures) and approximately 1, 24, 48 and 72 hours later.
Number of animals:
three
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: no data
- Type of wrap if used: approximately 0.5 g of the test substance was applied under a 2-ply 25 mm x 25 mm porous gauze pad secured with ‘blenderm’ surgical tape to intact skin sites on three animals.

REMOVAL OF TEST SUBSTANCE
- Washing: animals were washed with lukewarm water (30-40 deg C) to remove any residual test substance. The treated area was blotted dry with absorbent paper.
- Time after start of exposure: after 3 minutes or one hour exposures.

SCORING SYSTEM
- At 1, 24, 48 and 72 hours, erythema/eschar, oedema and the Primary Irritation Index (PII) and Classification were scored according to the Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: Means of scores at approximately 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: Means of scores at approximately 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: Means of scores at approximately 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: Means of scores at approximately 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: Means of scores at approximately 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: Means of scores at approximately 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
8
Remarks on result:
other: non-irritant
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Time point:
other: 1, 48 and 72 hours
Score:
0
Max. score:
8
Remarks on result:
other: non-irritant
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Time point:
other: 24
Score:
1
Max. score:
8
Remarks on result:
other: mildly irritating
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
8
Remarks on result:
other: non-irritant
Irritant / corrosive response data:
A single case of very slight erythema was apparent 24 hours after bandage removal; no other sign was apparent at any treatment site at any time during the study period.
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Conclusions:
The Primary Irritation Index was calculated to be 0.1; VRT-126016 was classified as ‘mildly irritating’ according to the criteria of the ECETOC and did not require labelling with the risk phrase R38, “Irritating to skin,” in accordance with Commission Directive 2001/59/EC.
Executive summary:

Not applicable