5-hept-6-enyloxolan-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 to 24 December 2004.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline No. 404 with minor deviations: details on feeding and environmental conditions not reported. The substance is adequately identified. Therefore full validation applies.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

April 24th, 2002

Deviations:

yes

Remarks:

details on feeding and environmental conditions not reported

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:

yes

Remarks:

details on feeding and environmental conditions not reported

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 2004-07-01 / Signed on 2004-09-13

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

457-810-6

EC Name:

-

Cas Number:

854737-08-9

Molecular formula:

C11 H18 O2

IUPAC Name:

5-hept-6-enyloxolan-2-one

Test material form:

liquid

Details on test material:

- Physical state: colourless liquid
- Storage condition of test material: Room temperature

Specific details on test material used for the study:

- Date received: 09 December 2004

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: 2.19-2.44 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: No data
- Water: No data
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-21 °C
- Humidity: 28-54 %
- Air changes: No data
- Photoperiod: No data

IN-LIFE DATES: From 14 To 24 December 2004

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

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.

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 the right 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.

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:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 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:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: Not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

It was only noted a slight erythema, in one animal, at the examination time 24 hours.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Individual and average scores after 4 h exposure

Observations		Score
Skin reactions	Observation time	Animal no. A6366	Animal no. A6373	Animal no. A6396
Erythema and eschar	24 h	0	1	0
	48 h	0	0	0
	72 h	0	0	0
	Total (24, 48 and 72 h)	0	1	0
	Mean (24, 48 and 72 h)	0.0	0.3	0.0
Oedema formation	24h	0	0	0
	48 h	0	0	0
	72 h	0	0	0
	Total (24, 48 and 72 h)	0	0	0
	Mean (24, 48 and 72 h)	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under these experimental conditions, test item must not be classified according to the CLP Regulation (EC) No. 1272/2008 and Globally Harmonized System (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 right flank of 3 male New Zealand White rabbits. On the left 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. Initially, a single animal was treated. After consideration of the cutaneous responses produced in the first treated animal, two additional animals were treated.

 

It was only noted a slight erythema, in one animal, at the examination time 24 hours. This reaction was totally reversible on day 2.

 

The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 0.0 / 0.3 / 0.0 for erythema and 0.0 / 0.0 / 0.0 for oedema.

 

Under these experimental conditions, test item must not be classified according to the CLP Regulation (EC) No. 1272 /2008 and Globally Harmonized System (GHS).

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