Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004-04-26 to 2004-05-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 2002-04-24
Deviations:
yes
Remarks:
body weight at end of study and clinical signs were missing in the study report
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
, 2004
Deviations:
yes
GLP compliance:
yes

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
- Molecular formula: C16H15NO4
- Molecular weight: 285.3 g/mole

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS - stock: Chbb:HM; SPF albino rabbits
- Source: Charles River Deutschland, Kißlegg, Germany
- Age at study initiation: approx. 8 months
- Weight at study initiation: 2.0 - 2.3 kg bw
- Housing: rabbits were caged individually in PPO cages (floor area: 2576 sq.cm) with perforated floor.
- Diet (ad libitum): a pelleted complete rabbit diet "Altromin 2123" (supplier: Altromin, Lage, Lippe; Germany)
- Water (ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature: 20°C ± 3°C
- Relative humidity: 55% ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: olive oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test material

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL olive oil
Duration of treatment / exposure:
initial animal: 3 minutes, 1 hour and 4 hours
Confirmatory animals:
Observation period:
immediately, 1 hour, 24 hours, 48 hours and 72 hours as well as on day 7 after termination
Number of animals:
3 female rabbits
Details on study design:
An initial test with one animal was carried out first followed by a confirmatory test with two animals..

TEST SITE
The day before the treatment the skin area on the back of the rabbits was clipped as closely as possible with an electric clipper.
The test item was applied to a 16-layer gauze patch (2.5 x 2.5 cm) and moistened with the vehicle, the patch was placed on the skin and secured semi-occlusively with adhesive Gothaplast tape (2.5 cm). After an exposure time of 3 minutes. The first patch was removed, the treated skin was cleaned with mild soap and lukewarm water. A first assessment of the skin reaction took place immediately after the termination of exposure.
No corrosive effects were observed and a second patch with test item was applied on the rabbit back. In order to improve the patch securing the trunk of the animal was additionally wound with 5 cm wide adhesive Gothaplast tape. After an exposure time of 1 hour the second patch was removed, the treated skin was cleaned with mild soap and lukewarm water. The skin reaction was first assessed immediately after the termination of exposure.
Again no corrosive effects were observed and the exposure time was extended to 4 hours. An amount of the test item was applied on a third patch, was moistened with 0.1 ml olive oil and put on the skin. Adhesive Gothaplast tape (2.5 cm and 5 cm wide) served again as the semiocclusive securing. After a 4-hour exposure time the third patch was removed, the treated skin was cleaned with mild soap and lukewarm water. The first assessment of the skin reaction took place again immediately after the termination of exposure.

A confirmatory test with two animals was carried out after the initial test. The animals were treated the same way as in the initial test except that the animals were only exposed for 4 hours.

SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
The animal used in the initial test showed no skin reactions immediately after the application.
1 hour after the termination of exposure no signs of skin irritation were observed at any animal.
24, 48 and 72 hours after the termination of exposure one animal showed a very slight erythema, whereas the other animals were free of any signs of skin irritation. 7 days after the termination of exposure this animal was free of any signs of skin irritation
Other effects:
1 hour after the termination of exposure no signs of skin
irritation were observed at the 3 animals.

24, 48 and 72 hours after the termination of exposure one of
the animals showed a very slight erythema on the anterior
right test field, whereas no skin reactions were observed

at the other two animals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritating.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritating.