5-Brom-2-[(3,4,5-trifluorphenoxy)-difluormethyl]-1,3-difluorbenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Jun - 07 Aug 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluorobenzene

EC Number:

610-623-5

Cas Number:

511540-64-0

Molecular formula:

C13 H4 Br F7 O

IUPAC Name:

5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluorobenzene

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Kisslegg
- Age at study initiation: approx. 27 weeks
- Housing: the rabbits were housed individually in special rabbit cages, with plastic grids placed on mobile racks. The collection pans underneath the cages were cleaned at least 3x per week.
- Diet: Pelleted Provimi Kliba 3418 rabbit maintenance diet, ad libitum (Provimi Kliba AG, Kaiseraugst, Switzerland) and ssniff K snack
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 46-77
- Air changes (per hr): air-conditioned room
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

other: not required, untreated sites of the same animal served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
the test material was moistened with some drops of purified water before application

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h and then daily up to experimental day 8.

Number of animals:

3 (females)

Details on study design:

PRETESTS:
Prior to testing, the pH of a preparation of the test material was determined with pH test stripes. The pH was found to be approx. 7.

TEST SITE
- Area of exposure: approximately 6 cm²
- Type of wrap if used: the test substance was applied on the intact, shaved skin on a surgical gauze and the area was covered with a semi-occlusive dressing. The patch was held in place with non-irritating semi-occlusive adhesive tape that was wrapped around the abdomed of the animals.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the patches were removed and any test material residues were wiped off dry
- Time after start of exposure: 4 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- For solids, paste formed: yes

SCORING SYSTEM: Draize scoring system acc. to EEC commission directive 92/69/EEC

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No skin irritation effects were observed; all scores were 0 at all reading time points (after 1 ,24, 48, 72 hours and 7 days) for 3/3 animals.

Other effects:

There was no mortality and no clinical signs of toxicity were observed during the study period. The body weight gains were within the normal ranges during the study period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, no signs of irritations were seen. Therefore, the test item is not considered to be irritating to skin.

Executive summary:

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with one animal and followed by the confirmatory test with two further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for further 7 days.

Under the conditions of the present study, no signs of irritations were seen. Therefore, the test item is not considered to be irritating to skin.