cyclohexadecanone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 - 16 Feb 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Deviations:

yes

Remarks:

occlusive instead of semi-occlusive dressing; 4 test substance concentrations were tested; 4 rabbits instead of 3 rabbits were used

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

(Commission Directive 92/69/EEC)

Deviations:

yes

Remarks:

4 substance concentrations were tested

GLP compliance:

yes (incl. QA statement)

Remarks:

MINISTERIUM FÜR RAUMORDNUNG UND UMWELT DES LANDES SACHSEN-ANHALT, Germany

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

438-930-8

EC Name:

-

Cas Number:

2550-52-9

Molecular formula:

C16H30O

IUPAC Name:

cyclohexadecanone

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

SPF Crl:NZW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2465 - 2720 g
- Housing: in stainless steel cages (50 x 55 x 40 cm) with bottom grid of oval steel and with tub for faeces, granulated soft wood bedding
- Diet: ALTROMIN 2123 standard diet for rabbits (ALTROMIN, Lage/Lippe, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.5 - 22.5
- Humidity (%): 30 - 40
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: mixture of ethanol/diethylphthalate 1:1 (v/v)

Remarks:

(used for moistening of the test substance)

Controls:

yes, concurrent no treatment

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g
- Concentrations: 10, 25, 50% [w/v], 100% (undiluted)

VEHICLE
- Amount applied: 0.5 mL
- Lot/batch no.: S31826035 (Diethylphthalate), 46047117 (Ethanol)

Duration of treatment / exposure:

4 h

Observation period:

72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

4 males

Details on study design:

TEST SITE
- Area of exposure: three pairs of areas of approx. 4 x 5 cm at the dorsal area of the trunk so that one of each pair lies on each side of the spine
- Type of wrap if used: one layer of gauze patch (two layers of gauze patch for test substance solutions and for the vehicle) covered with aluminium foil, which was held in contact with the skin by occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: The application area was rinsed with a mixture of ethanol/diethylphthalate 1:1 (v/v) without altering the integrity of the epidermis.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 h

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 4 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

All skin areas, treated with the moistened original test item or with solutions of the test item in the vehicle (50, 25 and 10 % [w/v]) and also the control skin areas (untreated and treated with vehicle), did not show any alterations at any observation time.

Any other information on results incl. tables

No animal died during the course of investigation and no clinical signs were observed. Necropsy was not carried out, because no clinical signs were observed.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions of the Acute Dermal Irritation/Corrosion Test in rabbits the test substance does not possess any skin irritating potential.

Executive summary:

The skin irritation potential of the test substance was determined by an in vivo skin irritation test (2001) in albino rabbits according to OECD Guideline 404 and in compliance with GLP. 0.5 g of the crushed test substance moistened with ethanol/diethylphthalate 1:1 (v/v) and 0.5 mL of the test substance in dilutions of 10, 25 and 50% (w/v) in ethanol/diethylphthalate 1:1 (v/v) were applied to the skin of four rabbits under occlusive conditions for 4 hours. After the exposure period the patch was removed and the administration areas were rinsed with ethanol/diethylphthalate 1:1 (v/v) . Scores were taken 1, 24, 48 and 72 hours after patch removal using the Draize scoring system. All skin areas, treated with the undiluted or with one of the three solutions of the test substances, did not show any alterations at any observation time point. The overall mean score after 24, 48 and 72 hours for erythema and edema of all animals was 0. Based on the results, the undiluted test substance as well as the 10, 25 and 50% (w/v) solutions were not irritating to the skin under the conditions of the test.