1-(4-trans-Propyl-[1,1-bicyclohexyl]-4-trans-yl)-4-trifluormethoxybenzene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

in vivo study

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 07, 1992 - June 12, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene

EC Number:

603-929-5

Cas Number:

135734-59-7

Molecular formula:

C21H29F3O

IUPAC Name:

1-[4'-trans-Ethyl-[1,1'-bicyclohexyl]-4-trans-yl-]-4-trifluormethoxybenzene

Test material form:

solid

Specific details on test material used for the study:

Batch: E919140

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SAVO-Ivanovas, Kißlegg
- Age at study initiation: about 28 weeks
- Weight at study initiation:3.24 (3.13 - 3.43) kg
- Housing: separately in special rabbit cages (manufacturer: Hulskamp, type KK 017)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: more than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 32°C
- Humidity (%): 39 - 61%

IN-LIFE DATES: From: day 1 To: day 8

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Liquid paraffin

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g per animal

Duration of treatment / exposure:

4 hours

Observation period:

8 days

Number of animals:

3 (2 male & 1 females)

Details on study design:

TEST SITE
- Area of exposure: left side of the animal back (Test item), right side of the animal back (Carrier)
- Type of wrap if used: polyethylene foil, which was kept in place by a leather sleeve

REMOVAL OF TEST SUBSTANCE
- Method: wiped off
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1 hour after removal, after 24, 48, 72 hours, and then daily up to experimental day 8

SCORING SYSTEM:
Evaluation of skin reactions according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 7 days

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:

In the primary skin irritation test, erythema (scores 1 and 2) was observed in all animals from days 2 until 7 of the study. The rabbits revealed also scales from days 6 until 12 of the study.

The cumulative mean scores for erythema were:
Day 1: 0.0 (1 hour)
Day 2: 1.3 (24 hours)
Day 3: 1.3 (48 hours)
Day 4: 1.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Any other information on results incl. tables

Study design

To test for primary skin irritation, 0.5 g of the test material was mixed with some drops of liquid paraffin to ensure good contact to the skin. Afterwards, the test material was spread onto 4 cm2 patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under occlusive conditions.

The first examination of the treated skin sites followed 1 hour after removal of the patches. Then examinations were performed daily for further 7 days.

Results

In the primary skin irritation test, erythema (scores 1 and 2) was observed in all animals from days 2 until 7 of the study. The rabbits revealed also scales from days 6 until 12 of the study.

The cumulative mean scores for erythema were:

Day 1: 0.0 (1 hour)

Day 2: 1.3 (24 hours)

Day 3: 1.3 (48 hours)

Day 4: 1.0 (72 hours)

Edema have not been observed.

The control sites, treated with liquid paraffin, showed no signs of irritation.

Conclusions

According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3. Thus, the test item is considered to be a skin irritant.

Executive summary:

This study was performed according to GLP and methods applied are fully compliant with OECD TG 404. According to the results of the study, for regulatory purposes there is no need for classification as the animal's individual mean scores (considering readings at 24 h, 48 h, and 72 h after patch removal) were below 2.3.