1-Decene, 1-ethoxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Between 02 October 2001 and 16 October 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols and under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

440-020-0

EC Name:

-

Cas Number:

61668-40-4

Molecular formula:

C12H24O

IUPAC Name:

Dec-1-en-1-yl ethyl ether

Test material form:

other: clear colourless liquid

Details on test material:

Sponsor's identification: ARCTICAL
Chemical name: 1-decene, 1-ethoxy
CAS number: 61668-40-4
Purity: 97.8%
Stability: stable under nonnal temperatures and pressure
Description: clear colourless liquid
Batch number: ES 7565L/2
Storage conditions: room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A reputable UK supplier
- Age at study initiation: Twelve to sixteen weeks old
- Weight at study initiation: 2.0 to 3 .5 kg
- Housing: Individually housed in suspended metal cages.
- Diet: Free access to food (Certified Rabbit Diet (Code 5322) supplied by a reputable UK supplier
- Water: Free access to mains drinking water
- Acclimation period: At least five days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°C
- Humidity: 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour
- Photoperiod: Lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.









.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 ml of the test material

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

TEST SITE
On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animalswith a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset and the animals were returnedto their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cottonwool soaked in 74% Industrial Methylated Spirits.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #37

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

other: Moderate desquamation and reduced regrowth of fur observed at 14 d

Results 2

Irritation parameter:

erythema score

Basis:

animal: #43

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: Crust formation and reduced regrowth of fur observed at 14 d

Results 3

Irritation parameter:

erythema score

Basis:

animal: #49

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Remarks on result:

other: Moderate desquamation and reduced regrowth of fur observed at 14 d

Results 4

Irritation parameter:

edema score

Basis:

animal: #37

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 5

Irritation parameter:

edema score

Basis:

animal: #43

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Results 6

Irritation parameter:

edema score

Basis:

animal: #49

Time point:

other: Mean of scores at 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 d

Irritant / corrosive response data:

Well-defined erythema was noted at all treated skin sites one hour after patch removal and persisted at all treated skin sites at the 24. 48 and 72-hour observations. Other reactions noted were light brown discolouration of the epidermis, skin reactions extending approximately 4 cm beyond the site of application. loss of skin elasticity, crust formation. moderate desquamation and reduced re growth of fur. Adverse reactions prevented the evaluation of erythema at the 7 -day observation.
Very slight to slight oedema was noted at all treated skin sites one hour after patch removal with slight oedema noted at all treated skin sites at the 24, 48 and 72-hour observations. Adverse reactions prevented evaluation of oedema at the 7-day observation.

Any other information on results incl. tables

Individual Skin Reactions

Skin Reaction	Observation Time	Individual Scores – Rabbit Number and Sex			Total
		37 Female	43 Male	49 Male
ErythemalEschar Formation	1 Hour	2	2	2	(6)
	24 hours	2 R	2 Br	2 R	6
	48 Hours	2 RLe	2 BrLe	2 RLe	(6)
	72 Hours	2 RLe	2 BrLe	2 RLe	6
	7 Days	?eCf	?eCf	?eCf	(0-12)
	14 Days	0 DFr	0 CfFr	0 DFr	(0)
Oedema Formation	1 Hour	1	2	2	(5)
	24 hours	2	2	2	6
	48 Hours	2	2	2	(6)
	72 Hours	2	2	2	6
	7 Days	?od	?od	?od	(0-12)
	14 Days	0	0	0	(0)
Sum of 24 and 72-hour Readings (S):		24
Primary Irritation Index (S/6):		24/6 = 4.0
Classification:		MODERATE IRRITANT

( ) = Total values not used for calculation of primary irritation index

Br = Light brown discolouration of the epidermis

Cf= Crust formation

D = Moderate desquamation

Fr = Reduced regrowth of fur

Le = Loss of skin elasticity

R = Reaction extends beyond site of application

?e = Adverse reactions prevent evaluation of erythema

?od = Adverse reactions prevent evaluation of oedema

Interpretation of Results

Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme

The scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test material. The test material was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the,,, p.47:

Primary Irritation Index	Classification of Irritancy
0	Non-irritant
> 0 to 2	Mild irritant
> 2 to 5	Moderate irritant
> 5 to 8	Severe irritant

If irreversible alteration of the dermal tissue is noted in any rabbit, as judged by the Study Director, which include ulceration and clear necrosis or signs of scar tissue, the test material is classified as corrosive to rabbit skin. Classification according to Draize may, therefore, not be applicable.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Category 2: Irritant Criteria used for interpretation of results: EU

Conclusions:

The test material produced a primary irritation index of 4. 0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

The irritant effects of Arctical to rabbit skin was assessed in a GLP study according to OECD Guideline No. 404. A quantity of 0.5 ml of test substance was applied to the intact skin of three rabbits. Four hours after application the corset and patches were removed from each animal. Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of irritation and scored. Additional observations were made on Days 7 and 14 to assess the reversibility of skin reactions. In accordance with the classification criteria set out in CLP Regulation (EC) 1272/2008 the test material is considered to be Category 2: Irritant