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Diss Factsheets

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:
08 - 11 Mar 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Current version adopted in 2015
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
Guideline in place during study conduct: adopted in 1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
Adopted in 1984
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Agricultural chemicals, Laws and Regulations Japan, MAFF (p. 25 - 26)
Version / remarks:
Adopted in 1985
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
443-870-0
EC Name:
-
Cas Number:
163520-33-0
Molecular formula:
C18H17NO3
IUPAC Name:
ethyl 5,5-diphenyl-4,5-dihydro-1,2-oxazole-3-carboxylate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Chemisch Pharmazeutische Fabrik, SPF-Zucht, Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: approx. 3 - 5 months
- Body weight at study initiation: 2.4 - 2.5 kg
- Housing: individually in separate cages
- Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe, Germany), ad libitum; hay, approx. 15 g daily
- Water: tap water in drinking water quality, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Air changes: fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 Mar 1994 To: 11 Mar 1994

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: Polyethylene glycol 400
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g

VEHICLE
- Amount(s) applied: 0.35 mL
- Concentration: 0.5 g of the test substance were moistened with 0.35 mL polyethylene glycol 400
Duration of treatment / exposure:
4 h
Observation period:
Examinations of the skin took place 30 - 60 min, and 24, 48, and 72 h after removal of the patch.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The moistened test substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (Beiersdorf AG, Hamburg, Germany). The plaster was fixed to the prepared skin area and then covered with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test substance was removed with warm tap water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
30 - 60 min, and 24, 48, and 72 h after removal of the patch

SCORING SYSTEM:
- Method of calculation: Erythema, eschar formation, and oedema were evaluated numerically according to the Draize scoring system.

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
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The test substance caused no dermal reactions in any of the test animals throughout the observation period.
Other effects:
No clinical signs of systemic toxicity were observed during the observation period.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
Conclusions:
Based on the results of the present study, the test substance is considered to be non-irritating to the skin of rabbits.