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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999-01-26 to 1999-01-29
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(3,5-Dihydroxyphenyl)-1-oxo-2-(N-1-(4-methoxyphenyl)isopropylamino)ethane Hydrobromide
EC Number:
928-779-0
Molecular formula:
C18-H21-N-O4 x HBr
IUPAC Name:
1-(3,5-Dihydroxyphenyl)-1-oxo-2-(N-1-(4-methoxyphenyl)isopropylamino)ethane Hydrobromide
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: No details on the source of the test material were provided. Batch number: 323.
- Expiration date of the lot/batch: 16 December 1999 (allocated by testing facility, 1 year after reciept of the test substance).
- Purity test date: No details reported.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature in the dark.
- Stability under test conditions: Stable
- Solubility and stability of the test substance in the solvent/vehicle: The vehicle was selected nased on a pretest performed at the testing facitlity. The stability of the test substance in the vehicle was not indicated.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was moistened with Milli-U water immediately before application, to ensure close contact with the animal's skin.
- Preliminary purification step (if any): No details reported.
- Final dilution of a dissolved solid, stock liquid or gel: No details reported.
- Final preparation of a solid: No details reported.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: Less than 3.5 kg
- Housing: Individually in cages with perforated floors (Scanuber, Denmark)
- Diet (e.g. ad libitum): approx.100 gram per day. In addition, hay was provided once a week.
- Water (e.g. ad libitum): Free Access
- Acclimation period: at least 5 days under laboratory conditions.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day



Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
Volume not reported.
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): Not reported

VEHICLE
- Amount(s) applied (volume or weight with unit): Not reported.
- Concentration (if solution): Not reported. The powdery test substance was moistened with water (Milli-U), immediately before application, to ensure close contact with the animal´s skin.
- Lot/batch no. (if required): Not reported.
- Purity: Not reported.

NEGATIVE CONTROL
No details reported.

POSITIVE CONTROL
Not applicable.
Duration of treatment / exposure:
4 h
Observation period:
Mortality/Viability: Twice daily
Toxicity: At least once daily
Body weight: Day of treatment (prior to application)
Skin reactions after removal of dressing and test substance: 1, 24, 48 and 72 h
Number of animals:
3 (male)
Details on study design:
TEST SITE
- Area of exposure: 150 cm^2 (10x15 cm^2), dorsal
- Type of wrap if used: Metalline patch (Lohmann GmbH, Neuwied, Germany) of 2x3 cm. The patch was mounted on Micropore tape (3M, St. Paul, U.S.A.), which was wrapped around the abdomen and secured with Coban elastic bandage (3M, St. Paul, U.S.A.)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize scoring system, detailed in the report as follows:

Erythema and Eschar Formation:
No erythema = 0
Very slight erythema (barely perceptible)= 1
Well defined erythema = 2
Moderate to severe erthema = 3
Severe erythema (beet redness) = 4
In cases where signs of necrosis or corrosion prevent erythema scoring, the maximum grade for erythema (=4) is given.

Oedema Formation:
No oedema = 0
Very slight oedema (barely perceptbile) = 1
Slight oedema (edges of area well defined by definite raising) = 2
Moderate oedema (raised approximatley 1 mm) = 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) = 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No skin irritation was caused by 4 hours of exposure to the test substance. There was no evidence of a corrosive effect on the skin.
Other effects:
Yellowish staining of the treated skin was observed on day 1 (no further details reported).

Any other information on results incl. tables

Irritation

No skin irritation was caused by 4 hours of exposure

Corrosion

There was no evidence of a corrosive effect on the skin

Colouration

Yellowish staining of the treated skin by the test substance was observed on day 1.

Toxicity/Mortality

No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No skin irritation was caused by 4 hours of exposure to the test substance. There was no evidence of a corrosive effect on the skin. Based on the results of this study, the test substance is classified as not skin irritating according to CLP criteria.

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