Cyclopentadecanone

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

12 February 2001-16 February 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Official Journal of the European Union No. L 383 A, p. 124 - 127 of December 29, 1992

Deviations:

yes

Remarks:

Observation period 72 hours, occlusive dressing

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

EC Number:

607-739-3

Cas Number:

2550-52-9

Molecular formula:

C16H30O

Test material form:

solid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: unsoluble in water

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was administered as the original substance alter crushing with a pestle and mortar to a fine dust moistened using a mixture of ethanol*/diethylphthalate* 1:1 (v/v) (as ED abbreviated in the following text) or as solutions with fixed concentrations in this mixture.

Test animals

Species:

rabbit

Strain:

New Zealand White

Remarks:

Crl:NZW

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, D-97320 Sulzfeld, Germany
- Weight at study initiation: 2720, 2465, 2615 and 2626 g (average 2607 g)
- Housing: Cages of stainless steel with bottom grid of oval steel and with tub for faeces, dimensions of the cages: 50 x 55 x 40 cm
- Diet (e.g. ad libitum): ALTROMIN 2123, standard diet for rabbits ad libitum (ALTROMEN, D-32791 Lage/Lippe)
- Water (e.g. ad libitum): tap water, ad libitum (municipal supply), Makrolon® b ottles, changed daily
- Acclimation period: 7 days

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

IN-LIFE DATES: From: February 12, 2001 To: February 16, 2001

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

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

Controls:

yes, concurrent no treatment

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g crushed material moistened using a mixture of ethanol/diethylphthalate or 0.5 mL of a 50, 25 and 10% (w/v) solution in a mixture of ethanol/diethylphthalate (1:1 v/v)
- Concentration (if solution): solid material, 50, 25 and 10%

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

Duration of treatment / exposure:

4 hours

Observation period:

60 minutes, 24, 48 and 72 hours post patch removal

Number of animals:

4 (four different concentrations were applied to the trunk of each of the four animals)

Details on study design:

TEST SITE
- Area of exposure: approx. 2 x 3 cm
- % coverage: 100
- Type of wrap if used: occlusive dressing (Lohmann GmbH & Co., Neuwied)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with a mixture of ethanol/diethylphthalate 1:1 (v/v)
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 60 minuts, 24, 48 and 72 hours

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

pure test substance, 50%, 25% and 10% solutions

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no skin effects were observed

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Remarks:

pure test suibstance, 50%, 25% and 10% solutions

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no skin reactions were noted

Irritant / corrosive response data:

All skin areas, treated with the moistened original test item or with solutions of the test item in three concentrations (50, 25 and 10 %) and also the control skin areas (untreated and treated with ethanol/diethylphthalate), did not show any alterations at any observation time.

Other effects:

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:

GHS criteria not met

Conclusions:

Based on the reliable guildeine study with 4 rabbits, the test substance cyclohexadecanone was not irritating to rabbit skin.

Executive summary:

In the GLP-compliant study performed according to the EU B.4 method the test substance cyclohexadecanone was not irritating to rabbit skin, when administered as a pure substance and 10%, 25% and 50% solution in ethanol/diethylphthalate (1:1) v/v for 4 hours to 4 rabbits under occlusive dressing. Animals were observed for 60 minutes, 24, 48 and 72 hours. No skin reactions were noted in any animal at any time point. Based on the results of the study, the test substance cyclohexadecanone is considered to be not irritating to skin.