Cyclohexanepentanol, .beta.-methyl-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2008-03-18 to 2008-04-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 2002-04-24

Deviations:

yes

Remarks:

See "Principles of method if other than guideline"

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

See "Principles of method if other than guideline"

Principles of method if other than guideline:

Deviation from guideline without an effect on the results: According to the guideline, systemic effects should be recorded. This was missing in the study report. According to the guideline, the individual bodyweight of the rabbits at the conclusion of the study should be stated. This was missing in the study report.

GLP compliance:

yes (incl. QA statement)

Remarks:

signed 2007-10-15

Test material

Test material information

Constituent 1

Reference substance name:

(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol

EC Number:

700-146-1

Cas Number:

1141487-54-8

Molecular formula:

C12H24O

IUPAC Name:

(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: animals were individually housed in suspended cages.
- Diet (ad libitum): Certified Rabbit Diet
- Water (ad libitum): mains drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23 °C
- Relative humidity: 30 to 70 %
- Air exchanges: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the test material

Duration of treatment / exposure:

4 hours

Observation period:

approximately one hour following the removal of the patches, and 24, 48 and 72 hours later and on Days 7 and 14.

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: 2.5 cm x 2.5 cm cotton gauze patch, which was secured in position with a strip of surgical adhesive tape. The trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: four hours after application

SCORING SYSTEM: according to the Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Also observed: loss of skin elasticity (at 48 and 72 h), light brown discolouration of the epidermis (at 72 h), loss of skin flexibility (at 72 h) and moderate desquamation (at Day 7).

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Also observed: light brown discolouration of the epidermis (at 72 h) and moderate desquamation (at Day 7).

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Also observed: light brown discolouration of the epidermis (at 72 h), loss of skin elasticity (at 72 h) and crust formation (at Day7).

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Irritant / corrosive response data:

Very slight erythema was noted at all treated skin sites one hour after patch removal. Well-defined erythema and very slight to slight oedema were noted at all treated skin sites at the 24, 48 and 72 hour observations. Very slight erythema was noted at one treated skin site at the 7-day observation.


Loss of skin elasticity was noted at one treated skin site at the 48-hour observation and at two treated skin sites at the 72-hour observation. Loss of skin flexibility was noted at one treated skin site at the 72-hour observation. Light brown discolouration of the epidermis was noted at all treated skin sites at the 72-hour observation. Moderate desquamation was noted at two treated skin sites with crust formation noted at the remaining treated skin site at the 7-day observation.

All treated skin sites appeared normal at the 14-day observation.

No corrosive effect were noted.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

According to the EC Regulation No. 1272/2008 and subsequent regulations, the test substance is not a skin irritant