dec-9-en-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 15 January and 05 February 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline No. 404 without any deviation.

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:

24 April 2002.

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Directive n° 2004/73/EC.

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 2007-01-11 / Signed on 2007-02-21.

Test material

Test material information

Constituent 1

Reference substance name:

dec-9-en-2-one

EC Number:

685-618-4

Cas Number:

35194-30-0

Molecular formula:

C10 H18 O

IUPAC Name:

dec-9-en-2-one

Test material form:

liquid

Details on test material:

- Physical state: colorless liquid
- Storage condition of test material: Room temperature, darkness.

Specific details on test material used for the study:

- The test item was considered at 100% for the study.
- Date received: 17 December 2007

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage de Gérome (Quartier Labaste – F40260 Linxe).
- Weight at study initiation: 2.42 - 3.05 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff, ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20-22 °C
- Humidity: 37- 64 %
- Air changes: no data
- Photoperiod: 12 hours light/12 hours dark.

IN-LIFE DATES: From 15 January to 05 February 2008.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Test item was applied as supplied.

Duration of treatment / exposure:

4 hours

Observation period:

Skin reactions were appreciated 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).

Number of animals:

3 males

Details on study design:

PRETEST
Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.

TEST SITE
- Area of exposure: Undamaged skin area of one flank of each animal
- Type of wrap if used: Patch was secured in position with a strip of surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: After removal of the patch, the treated area was rinsed with distilled water.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14 (in case of persistent reactions were observed).

SCORING SYSTEM:
- Method of calculation: Skin irritant reaction was scored as per Draize scale according to OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 days

Remarks on result:

probability of weak irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of mild irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of weak irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of mild irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 3 days

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

- A well defined erythema associated with a slight oedema was noted, 24 hours after the test item application, on the treated area.
- The oedematous reactions were totally reversible between D3 and D6 and the erythematous reactions were totally reversible at D6.
- On the cutaneous structure, a slight dryness was noted on the treated area, from D2 in one animal and from D3 in the two others animals. The skin recovered a normal aspect between D13 and D14.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Individual and mean skin reactions/Erythema - Eschar formation following 4 hour exposure

Skin reaction	Observation time (following patch removal)	Individual Scores – Rabbit Number and Sex
		A8715/Male	A8738/Male	A8739/Male
Erythema/Eschar formation	1 h	1	2	2
	24 h	2	2	2
	48 h	2	2	2
	72 h	1	2	1
	Day 6	0	0	0
	Total (24, 48 and 72 hours)	5	6	5
	Mean (24, 48 and 72 hours)	1.7	2	1.7

Table 7.3.1/2: Individual and mean skin reactions/Oedema formation following 4 hour exposure

Skin reaction	Observation time (following patch removal)	Individual Scores – Rabbit Number and Sex
		A8715/Male	A8738/Male	A8739/Male
Oedema formation	1 h	0	1	1
	24 h	2	2	2
	48 h	1	1	1
	72 h	0	1	0
	Day 6	0	0	0
	Total (24, 48 and 72 hours)	3	4	3
	Mean (24, 48 and 72 hours)	1	1.3	1

Note:

A8715: slight dryness at D2, D3, D6 to D10 &D13

A8738: slight dryness at D3, D6 to D10

A8739: slight dryness at D3, D6 to D10 &D13

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Under the test conditions, the test substance is not classified as irritating to skin according to the criteria of the Annex I of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.

Executive summary:

In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of undiluted test item was applied on an undamaged skin area of the flank of 3 male New Zealand White rabbits. On the other flank an untreated area was served as the control. Test sites were covered with a semi-occlusive dressing for 4 h. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 hours after removal of the patch and observations were continued from Days 4 to 14. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.

 

A well defined erythema associated with a slight oedema was noted, 24 hours after the test item application, on the treated area. The oedematous reactions were totally reversible between D3 and D6 and the erythematous reactions were totally reversible at D6. On the cutaneous structure, a slight dryness was noted on the treated area, from D2 in one animal and from D3 in the two others animals. The skin recovered a normal aspect between D13 and D14.

The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.7 / 2.0 / 1.7 for erythema and 1.0 / 1.3 / 1.0 for oedema.

Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the Annex I of the Regulation EC No. 1272/2008 (CLP) and classified in Category 3 (mild irritant) according to the GHS.

This study is considered as acceptable and satisfies the requirement for skin irritation endpoint.