Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 March - 29 March 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to OECD and EC guidelines and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

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
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Y-513
- Purity test date: no data
- Lot/batch No.: F-1570
- Expiration date of the lot/batch: 19 February 2013
- Stability under test conditions: stable
- 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
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: 1643 - 1815 g
- Housing: Individually in labeled cages with perforated floors (dimensions 56x44x37.5 cm).
- Diet (e.g. ad libitum): Pelleted diet for rabbits approximately 100 grams per day. Hay was provided at least three times a week.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.3 - 21.4
- Humidity (%): 44 - 57
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: watery ethanol (50% v/v)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.6 ml
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2x3 cm
- % coverage: 100
- Type of wrap if used: metalline patch of 2x3 cm. The 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


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean 24, 48 and 72 hrs
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation was observed after 4 hours exposure to the test substance.
There was no evidence of a corrosive effect on the skin. Yellow staining of the treated skin by the test substance was observed throughout the study period. The yellow staining did not hamper the scoring of the skin reactions.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Other effects:
No remnants of the test substance were present on the skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of an in vivo skin irritation test performed according to OECD and GLP guidelines, the test substance is considered to be not irritating to skin.
Executive summary:

An in vivo skin irritation test was performed according to OECD and GLP guidelines. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. No oedema or eryhtema was seen in any of the three animals, at any time point (24, 48 and 72 hours). Based on these data, Y-513 is found to be not-irritant and not corrosive to the skin and is thus not classified according to Regulation (EC) 1272/2008.