(1-ethoxyethoxy)cyclododecane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11-04-2000 to 21-07-2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed under GLP. All relevant validity criteria were met.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

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)

Remarks:

inspected: September 1999 ; signature: December 1999

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

446-240-3

EC Name:

-

Cas Number:

389083-83-4

Molecular formula:

C16H32O2

IUPAC Name:

(1-ethoxyethoxy)cyclododecane

Test material form:

liquid

Details on test material:

- Physical state: Liquid
- Storage condition of test material: At room temperature, protected from light and under nitrogen gas
- Other: colourless

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: Young adult
- Weight at study initiation: 2.4 ±0.1 kg
- Housing: Individually housed in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: certified rabbit diet ad libitum
- Water: filtered certified water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±3
- Humidity (%): 30 - 70
- Air changes (per hr): ca. 12 cycles/hr
- Photoperiod: 12 hours light / 12 hours dark

IN-LIFE DATES: From: 11-04-2000 To: 25-04-2000

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): 0.5mL
- Concentration (if solution): Not applicable.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours (initial observation); additional observations are made daily up to and including on Days 7 and 15 to assess the reversibility of skin reactions (as appropriate).

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsal
- Type of wrap if used: semi-occlusive ; gauze patch secured with semi-occlusive dressing and restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No, since no residual test item was observed following dressing removal.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48, 72 hours (initial observations); additional observations are made daily up to and including on Days 7 and 15 to assess the reversibility of skin reactions (as appropriate).

SCORING SYSTEM:
Consistent with Draize. Erythema and Eschar Formation:
No erythema ____________________________0
Very slight erythema (barely perceptible) _____1
Well-defined erythema ____________________2
Moderate to severe erythema ______________3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) _____________4

Oedema Formation
No oedema _____________________________0
Very slight oedema (barely perceptible) ______1
Slight oedema (edges of area well-defined by definite raising) _________________________2
Moderate oedema (raised approximately 1 millimetre) _________________________________3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) __4
Any other skin reactions and clinical signs of toxicity (clinical signs/behaviour), if present, were also recorded.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 1h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 1h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 9 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 1h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 1h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 10

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 11

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 12

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

- Erythema: Very slight or well defined erythema (score = 1 or 2) at all treated skin sites at 24 to 72 hours after patch removal and up to day 7 or 8 in two sites.
- Edema: No evidence of skin irritation was noted during the study.
- Reversibility of effects: All effects reversed within 9 days (3/3 sites) ; dryness of the skin was noted in all sites from day 5 (1/3), day 6 (2/3) or day 9 (1/3) which ceased in 2/3 sites by day 14.

Other effects:

- Other adverse local effects: None reported
- Other adverse systemic effects: None reported.

Any other information on results incl. tables

Table 1. Individual skin reactions

Skin Reaction	Observation Time	Individual Scores
		1 (male)	2 (male)	3 (male)
Erythema/Eschar formation	1 hour	1	1	1
	24 hours	2	2	2
	48 hours	2	1	2
	72 hours	2	1 S	2
	7 days	1	1 S	1 S
	14 days	0	0	0 S
Oedema formation	1 hour	0	0	0
	24 hours	0	0	0
	48 hours	0	0	0
	72 hours	0	0	0
	7 days	0 S	0 S	0
	14 days	0	0	0 S

S = dryness of the skin

 

Mean scores per organism at 24, 48 and 72h:

Erythemea/Escar Formation:

1: total = 6; mean score = 2.0

2: total = 4; mean score = 1.3

3: total = 6; mean score = 2.0

Oedema Formation:

1: total = 0; mean score = 0.0

2. total = 0; mean score = 0.0

3. total = 0; mean score = 0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the test item is not considered to be irritating.

Executive summary:

The study was performed to OECD TG 404 and EU Method B.4 in accordance with GLP to assess the primary skin irritancy potential of the test item in New Zealand White rabbits. Following single 4-Hour, semi-occluded applications to the intact rabbit skin. 0.5 ml of the test material was introduced under a gauze patch and placed in position on the clipped skin via semi-occlusive dressing to assess the irritancy potential of the test item. The patch was secured in position with a strip of surgical bandage. After 4 hours of exposure to the test item, the patches were removed, and individual dose sites were scored at approximately 1, 24, 48, and 72 hours. Daily observations were made up to day 15 as applicable. A single 4-Hour, semi occluded application of the test item to the intact skin of three rabbits produced very slight or well-defined erythema (score = 1 or 2) at all treated skin sites at 24 to 72 hours after patch removal and up to day 7 or 8 in two sites. Mean scores for following grading at 24, 48 and 72h were 2.0, 1.3 and 2.00 in erythema and eschar and 0.0 in all sites for the edema scoring criteria. Under the conditions of the study, the test item is not considered to be a skin irritant.