Isopropylcyclohexane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-02-22 to 1983-03-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

In deviation from OECD TG 404 occlusive dressing was used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

occlusive dressing

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isopropylcyclohexane

EC Number:

211-792-4

EC Name:

Isopropylcyclohexane

Cas Number:

696-29-7

Molecular formula:

C9H18

IUPAC Name:

(propan-2-yl)cyclohexane

Test material form:

liquid

Details on test material:

purity 99.8 %

Test animals

Species:

rabbit

Strain:

other: Small white Russian, Chbb-SPF

Details on test animals or test system and environmental conditions:

- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.4-2.9 kg Environmental conditions:
- Room temperature: 20°C (+/- 1°C);
- Humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- Water: tap water ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml undiluted test item

Duration of treatment / exposure:

4 hour(s)

Observation period:

- Post exposure observation period: 17 days
- Observations at 1, 24, 48, 72 hours, 6, 8 and 17 days after administration of the test substance

Number of animals:

3 males, 3 females

Details on study design:

- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing for 4 hours
- Removal of test substance: washing with warm water
- Scoring system: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1; 24; 48; 72 h

Score:

1.29

Max. score:

8

Reversibility:

fully reversible within: 17 days

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24; 48; 72 h

Score:

1.38

Max. score:

4

Reversibility:

fully reversible within: 17 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24; 48; 72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 1.38
- Edema: 0.17
- Irritation index: 1.29/8

Other effects:

no further information

Any other information on results incl. tables

no further information

Applicant's summary and conclusion

Conclusions:

According to the study, the test item showed slight irritant effect on the skin of male and female rabbits.

Executive summary:

The aim of this study was to examine the test item for acute skin irritation in rabbits (Patch-test) .

To test the acute skin irritant effect the test item was applied to the shaven dorsal skin of 3 male and 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.

The treated rabbits showed induration and dryness (day 6) of treated skin,  formation (days 8) and  subsequent detachment of  eschar until day 17.

According to the study, the test item isopropylcyclohexane showed slight irritant effect on the skin of male and female rabbits.