Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
An adequate in vivo study was conducted on the test article prior to the requirement for in vitro data.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
27 February 2007 to 24 March 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

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
Qualifier:
according to
Guideline:
other: EC, Council Directive 67/548/EEC, An. V, B.4 (2004), "Acute Toxicity: Dermal Irritation/Corrosion"
Deviations:
no
Qualifier:
according to
Guideline:
other: US EPA, OPPTS 870.2500 (1998), Acute Dermal Irritation
Deviations:
no
Qualifier:
according to
Guideline:
other: JMAFF Guidelines (2000) including the most recent partial revisions
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): MTDID 6675
- Substance type: Clear colourless liquid
- Physical state: Liquid
- Analytical purity: Formulation tested is 30% active ingredient in water.
- Purity test date: 12/20/2005
- Lot/batch no.: 140499-19/10
- Expiration date of the lot/batch: 01 December 2008
- Storage condition of test material: At room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan, Horst, The Netherlands
- Sex: male
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: At least 1.0 kg
- Fasting period before study: No data
- Housing: Individually in labelled cages with perforated floors (Scanbur, Denmark, Dimensions 56x44x37.5 cm)
- Diet (e.g. ad libitum): Pelleted diet for rabits (K-H from SSNIFF Spezialdiaten GmbH, Soest, Germany) approx 100 grams per day. Hay (TecniLab-BMI BV, Someren, The Netherlands) was provided at least three times a week.
- Water (e.g. ad libitum): Tap water ad libitum.
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1-22.5 degrees C
- Humidity (%): 40-58%
- Air changes (per hr): No Data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 27 February 2007 To: 24 March 2007

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the test substance (30% active ingredient in water)
- Concentration (if solution): 30% active ingredient in water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males were tested
Details on study design:
TEST SITE
- Area of exposure: Dorsal (10x15 cm)
- % coverage: No data
- Type of wrap if used: Substance awas applied to the skin of one flank using a metalline patch of 2x3 cm. Patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin cleaned of residual test substance using tap water
- Time after start of exposure: 4 hours after application.
SCORING SYSTEM: Erythema and eschar formation (0-4)
Oedema formation (0-4)

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0 - ca. 2
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Overall PII score was 0.44

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The PII score for the test was 0.44. The test material does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and EC criteria for classification and labelling requirements for dangerous substances and preparations.
Executive summary:

The purpose of this study was to assess the acute dermal irritancy of the test article in rabbits according to OECD Test Guideline 404. Three rabbits were exposed to 0.5 ml of the test article, by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. Exposure to the test material resulted in well defined erythema in the treated skin-area of the rabbits which had resolved within 48 hours in two animals and within 72 hours in the other animal. No edema was noted. Under the conditions of the test, the test material caused slight to well-defined erythema when applied to the skin of rabbits. The test material does not have to be classified and has no obligatory labelling requirement for skin irritation according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) and EC criteria for classification and labelling requirements for dangerous substances and preparations.