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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
The procedure used was the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
GLP compliance:
no
Remarks:
prior to GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)
EC Number:
230-426-4
EC Name:
2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)
Cas Number:
7128-64-5
Molecular formula:
C26H26N2O2S
IUPAC Name:
5-tert-butyl-2-[5-(5-tert-butyl-1,3-benzoxazol-2-yl)thiophen-2-yl]-1,3-benzoxazole

Test animals

Species:
rabbit
Strain:
other: White Russian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Age at study initiation: not specified
- Weight at study initiation: 1.5 to 2 kg
- Housing: individually in metal cages
- Diet: standard rabbit food - NAFAG, Gossau SG; ad libitum
- Water: ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 1
- Humidity (%): 55 +/-5
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.5g
For treatment gauze patches of 2.5 x 2.5 cm soaked with the test substance were applied to the prepared abraded and non abraded skin.
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
3 males, 3 females
Details on study design:
TEST SITE
- Area of exposure: flank and back, 2.5 x 2.5 cm
- Type of wrap if used: adhesive tape

REMOVAL OF TEST SUBSTANCE
- Washing: no
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
other: 24 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
other: 24 h, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The primary skin irritation index in this experiment was established to be 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met