4-cyclohexylphenol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

12th May 1981

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-cyclohexylphenol

EC Number:

214-465-4

EC Name:

4-cyclohexylphenol

Cas Number:

1131-60-8

Molecular formula:

C12H16O

IUPAC Name:

4-cyclohexylphenol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking & Churchill, Ltd., Huntingdon, England
- Weight at study initiation: 4 - 4.8 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): Ssniff K Pellets, ad libitum
- Water (e.g. ad libitum): drinking water ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

16-24h before exposure

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 50% solution in water

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL water

Duration of treatment / exposure:

4h

Observation period:

72h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6cm3 on the back
- Type of wrap if used: gauze patch (2.5 x 2.5 cm) applied to the skin, held in contact with the skin by Transfilmin dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed off with soap and water
- Time after start of exposure: 4h

OBSERVATION TIME POINTS: 1, 24, 48 and 72h

SCORING SYSTEM: Draize-grading

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

Test item is not irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study was conducted according to OECD guideline 404 on the registered substance itself. The method is to be considered scientifically reasonable. Hence, the results can be considered as reliable to assess the skin irritating properties of the test substance in rabbits. Scoring according to Draize resulted in mean value of 0 for erythema/edema in all three tested animals and hence, the substance can be considered to be not irritating to the skin.

Executive summary:

In a primary dermal irritation study (OECD guideline 404), male and female rabbits (three animals, New Zealand White) were dermally exposed to 500 mg of test substance as 50% aqueous solution for 4 hours to 6 cm². Animals then were observed for 7 days; irritation was scored by the method of Draize.

The substance has been determined to be not irritating to the skin (mean value of 0 for erythema/edema in all three tested animals).