(3E)-dec-3-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:

2009-04-16 to 2009-07-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3E)-dec-3-en-2-one

Cas Number:

18402-84-1

Molecular formula:

C10H18O

IUPAC Name:

(3E)-dec-3-en-2-one

Details on test material:

- CAS: 18402-84-1
- Purity: 98.57% to 99.11% w/w
- Batch No.: Lot KB 147-36-1
- Physical state: liquid
- Colour: Colorless to pale yellow
- Storage conditions: room temperature

Test animals

Species:

rabbit

Strain:

other: New Zealand albino

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Received from Robinson Services, Inc. Clemmons, NC on April 22, 2009
- Age at study initiation: Young adult
- Housing: The animals were singly housed in suspended stainless steel caging with mesh floors, which conform to the size recommendations in the most recent Guide for the Care and Use of Laboratory Animals DHEW (NIH). Litter paper was placed beneath the cage and was changed at least three times per week.
- Diet: Pelleted Purina Rabbit Chow #5326
- Water: Filtered tap water was supplied ad-libitum by an automatic water dispensing system
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22
- Humidity (%): 40-66
- 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

Duration of treatment / exposure:

4 hours

Observation period:

The animals were observed and scored for skin irritation according to Draize at 30-60 minutes, 24, 48 and 72 hours and at 7, 10 and 14 days after patch removal.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage: semi-occlusive
- Type of wrap if used: Micropore tape

REMOVAL OF TEST SUBSTANCE
- Washing: yes, ffter 4 hours of exposure to the test substance, the pads and the collars were removed and the test sites were gently cleansed of any residual test substance.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30-60 minutes, 24, 48 and 72 hours and 7, 10 and 14 days after patch removal.

SCORING SYSTEM:
- Method of calculation: According to Draize [J. Pharmacol. Exp. Ther. 1944, 82: 377-390]. The classification of irritancy was obtained by adding the average erythema and edema scores for the 30-60 minutes, 24, 48, and 72-hour scoring intervals and dividing by the number of evaluation intervals. The resulting Primary Dermal Irritation Index (PDII) was classified as follows:
PDII: 0 = non irritating
PDII >0 - 2.0 = slightly irritating
PDII 2.1 - 5.0 = Moderately irritating
PDII > 5.0 Severly irritating

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.66

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.33

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Irritant / corrosive response data:

Apart from one male exhibiting small feces on Day I, the animals appeared active and healthy during the study. One hour after patch removal, all three treated sites exhibited well-defined to severe erythema and moderate edema. At 48 hours through 72 hours, irritation increased to severe erythema for one animal. The overall incidence and severity of irritation decreased gradually thereafter. Although hyperkeratosis and desquamation were noted for all three animals between Days 7 and 14, they were free of erythema and edema by Day 14 (study termination). The Primary Dermal Irritation Index for the test substance is 5.5.
For detailed results please refer to table 1 and table 2 in box "Any other information on results incl. tables".

Any other information on results incl. tables

Table 1: Individual skin irritation score

Animal No	Sex	Time after patch removal
		30 -60 min	24 hrs	48 hrs	72 hrs	Day 7	Day 10	Day 14
3501	M	2/3	2/2	3/2	3/2	2/1^a	1/0^a,b	0/0^b,c
3502	M	3/3	3/3	3/2^d	3/2^d	2/1^a	0/0^a,b	0/0^b,c
3503	M	4/3^e	4/2^e	4/2^f	4/2^f	3/1^a,d	1/0^a,b	0/0^b,c

a Hyperkeratosis

b New skin

c Desquamation

d Small dark red areas in dose site.

e Dark red areas in dose site.

f Small black areas in dose site.

Table 2 : Summary of primary skin irritation scores*

	Time after patch removal
	30 -60 min	24 hrs	48 hrs	72 hrs	Day 7	Day 10	Day 14
Erythema	3.0	3.0	3.3	3.3	2.3	0.7	0
Edema	3.0	2.3	2.0	2.0	1.0	0	0
TOTAL (PDI)**	6.0	5.3	5.3	5.3	3.3	0.7	0

* Average values for three rabbits.

** PDI = Average Erythema + Average Edema

Primary Dennal Irritation Index (PDII): (PDI for 30-60 minutes, 24,48 and 72 hours) /4 = 5.5

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

In conclusion, the test item is severly irritating to the skin of rabbits when applied for 4 h under semi-occlusive conditions.

Executive summary:

In a primary dermal irritation study conducted according to OECD 404 three albino New Zealand White rabbits were dermally exposed to 0.5 mL the test item for 4 hours under semi-occlusive conditions. Animals then were observed for 14 days. Irritation was scored by the method of Draize. In this study, the test item is severely irritation to the skin based on the observation made. One hour after patch removal, all three treated sites exhibited well-defined to severe erythema and moderate edema. At 48 hours through 72 hours, irritation increased to severe erythema for one animal. The overall incidence and severity of irritation decreased gradually thereafter. Although hyperkeratosis and desquamation were noted for all three animals between Days 7 and 14, they were free of erythema and edema by Day 14. Based on these findings, the test item is considered to be irritant to the skin and in accordance with CLP Regulation 1272/2008 classification as Skin Irrit. 2 (H315) is warranted.