Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 Aug 2010 - 20 Aug 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study Analytical purity not given, responsibility of the sponsor.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Remarks:
Department of Health of the Government of the United Kingdom 2009

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HiPeaK
- Physical state: white powder
- Analytical purity: not given; responsibility of the sponsor
- Batch number: 9086
- Expiry date: 23 Dec 2011
- Storage conditions: room temperature in the dark under nitrogen
- pH (10% w/w aqueous preparation of the test item): 6.5 - 6.6

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Loughborough, UK
- Strain: Hsdlf:NZW
- Age at study initiation: 2.30 or 2.24 kg
- Weight at study initiation: 12-20 weeks
- Housing: individually in suspended cages
- Diet (ad libitum): 2030 Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd. Oxon, UK
- Water:ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped using veterinary clippers
Vehicle:
water
Controls:
other: non-treated sites served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied: 0.5 mL distilled water
Duration of treatment / exposure:
Animal #1: 3 minutes, 1 hour and 4 hours
Animal #2: 4 hours
Observation period:
72 hours
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area
A 2.5 cm x 2.5 cm cotton gauze patch was used to apply 0.5 g of the test substance moistened sufficiently with 0.5 mL of distilled water.
- Type of wrap if used: Surgical adhesive tape and elasticated corset

REMOVAL OF TEST SUBSTANCE
Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water.

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 2 animals and mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 4-hour exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 2 animals and mean of readings at
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Remarks on result:
other: 4-hour exposure

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU