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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:
June 19, 2000 - August 16, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
July 1992
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3,4,5-trifluorophenol
EC Number:
436-120-9
EC Name:
3,4,5-trifluorophenol
Cas Number:
99627-05-1
Molecular formula:
C6H3F3O
IUPAC Name:
3,4,5-trifluorophenol

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl:KBL(NZW)BR
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH, KiBlegg
- Age at study initiation: about 18 weeks
- Weight at study initiation: 3.39 kg
- Housing: special rabbit cages (manufacturer: Becker; type K99/30 KU, floor area about 5400 cm2, a shelter with an integrated sitting board of about 1820 cm2; overall height: 60 cm;) with plastic grids placed on mobile racks
- Diet: ad libitum, diet for rabbits No. 814 and No. 5697, Eberle Nafag
- Water: ad libitum, tap water
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21
- Humidity (%): 62 to 73
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
Aqua pro injectione
Controls:
no
Amount / concentration applied:
TEST MATERIAL
0.5 g of the test material was mixed with some drops of Aqua pro injectione and spread onto a patch of about 6 cm2. The patch was fastened to the left side of the animal's back and kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf).
- Amount(s) applied (volume or weight with unit): 0.5 g


Duration of treatment / exposure:
4 hours
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: animal's back and kept in place by a self-adhesive fabric (Fixomull® stretch, Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Washing: not specified

SCORING SYSTEM:
- Method of calculation: according to DRAIZE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritant / corrosive response data:
After a single application to the intact dorsal skin of a rabbit, for a 4 hours period of exposure under semiocclusive conditions, necrosis (Erythema and eschar formation: score 4) of the skin was observed in the treated area. Therefore the study was finished. No signs of pain or itching were detected.
Other effects:
-Results of Pre-test:
The test material was screened for its irritating potential with the hen's egg test on the chorioallantoic membrane (HET-CAM). Fertile hen eggs on day 10 of incubation provided the test system. The egg shell was entered above the air cell by a dentist's rotary and then pared off. The shell with attached outer membrane and inner egg membrane was carefully opened. After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the chorioallantoic membrane (CAM) of the fertilized egg, which lies immediately below. The chorioallantoic membrane (CAM) of fertilized and incubated hen eggs provides a suitable model for membranes with an intact and functional vascular system. The CAM has no nerve fibers in the early stages of development and is, thus, regarded as being insensitive to pain.In this model the cumulative irritation score was 8.84. This revealed a moderate irritating potential and the animal study was started with one rabbit.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The test item is regarded as corrosive to the skin.
Executive summary:

A study according to OECD TG 404 was performed to determine irritative/corrosive properties of the test item to the skin. The study was started with one rabbit. For the primary skin irritation, the test item was mixed with some drops of Aqua pro injectione to ensure good contact to the skin. Afterwards the test material was spread onto patches and applied to the intact skin of one previously shaven rabbit for a 4 hours period under semiocclusive conditions. The first examination of the treated skin sites followed after removal of the patches.

Strong local changes were seen, the study was finished and the rabbit was sacrificed. Necrosis was seen at the application site directly after removal of the patches. No signs of pain or itching could be observed.

Therefore, the test item is regarded as corrosive to the skin.