4'-trans-Butyl-[1,1'-bicyclohexyl]-4-on

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17.04.-09.05.1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

Acute dermal irritancy/corrosivity, OECD 1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

618-848-0

EC Number:

618-848-0

Cas Number:

92413-47-3

Molecular formula:

C16H28O

IUPAC Name:

618-848-0

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: SAVO-Ivanovas, Kisslegg
- Age at study initiation: about 17 - 19 weeks
- Housing: Healthy young rabbits were allocated to the different groups. The animals were kept in the experimental room for more than 7 days to allow for acclimatization. All rabbits were housed in an air-conditioned room of 39 m2 (No. 123) in the rabbit experimental station with daylight. They were kept separately in cages type KK 017 (floor area: 75 x 54.5 = 4087 cm2, height: 38 cm; manufacturer: Hulskamp) on metal grids. The paper underneath the cages was changed three times a week. The cages were machine-cleaned before the start of the study. The temperature varied from 21 to 24°C and the humidity from 43 to 64 %. The measurements were carried out using a thermohygrograph (type 252, Wilhelm Lambrecht KG, Göttingen).
- Diet: The rabbits received Altromin Standard Diet TPF(R) 2113, pellets and acidified, fully demineralized water from an automatic drinking device ad libitum. The diet is checked periodically by an independent and German Government approved testing laboratory, according to the regulations of the manufacturer. Analysis includes both qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics. Drinking water employed in this type of study is regularly investigated microbiologically. The analytical results show that the limits set by German regulations for animal feed have not been exceeded..

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: left and right side of the animals' back
- Type of wrap if used: polyethylene foil which was kept in place by a leather sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes (any test material on the left site was wiped off)
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : 1 hour after removal of the patches, and then daily for a period of further 7 days

SCORING SYSTEM:
- Method of calculation: according to DRAIZE

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:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 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

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, the GHS critera for skin irritation were not met. The test animals did not show a score between 2.3 and 4, but of 1 or less after exposion.

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 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. Thereafter, examinations were performed daily for further 7 days. Under the conditions of the present study, the criteria for classification according to GHS are not met. Therefore, the test item is not considered to be irritating to skin.