5-propyloxan-2-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 March to 07 April 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted according to OECD Guideline 404 with deviations: age at study initiation, feeding conditions not reported. These deviations do not affect the quality of the study and are not considered to be relevant.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

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:

yes

Remarks:

age at study initiation, feeding 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:

age at study initiation, feeding conditions not reported.

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Inspected on 2005-10-03 / Signed on 2005-12-13.

Test material

Test material information

Constituent 1

Reference substance name:

(5R)-5-propyloxan-2-one

Molecular formula:

C8 H14 O2

IUPAC Name:

(5R)-5-propyloxan-2-one

Constituent 2

Reference substance name:

(5S)-5-propyloxan-2-one

Molecular formula:

C8 H14 O2

IUPAC Name:

(5S)-5-propyloxan-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:

- Test item was considered at 100% for the study.

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: 2.48-2.86 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: 19-23 °C
- Humidity: 30-59 %

IN-LIFE DATES: 21 March to 07 April 2006

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

other: On the left flank an untreated area was served as the control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Undiluted

Duration of treatment / exposure:

4 h

Observation period:

Skin reactions were appreciated 1 hour and then 24, 48, 72 hours and Days 4 to 10 after removal of the patch.

Number of animals:

3 males

Details on study design:

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: The test item was applied, as supplied, at a dose of 0.5 mL, on an undamaged skin area of the right flank of each animal.
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
- Skin reactions were appreciated 1 hour and then 24, 48, 72 hours and Days 4 to 10 after removal of the patch.

SCORING SYSTEM: 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

Max. score:

4

Reversibility:

fully reversible within: 4 days

Remarks on result:

probability of weak irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 4 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:

1.7

Max. score:

4

Reversibility:

fully reversible within: 10 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:

0.7

Max. score:

4

Reversibility:

fully reversible within: 10 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:

2

Max. score:

4

Reversibility:

fully reversible within: 10 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:

0.3

Max. score:

4

Reversibility:

fully reversible within: 10 days

Remarks on result:

probability of weak irritation

Irritant / corrosive response data:

24 hours after the test item application, it was noted a well definite erythema, associated with a very slight oedema. The oedematous reactions were totally reversible between the 3rd and the 4th day of the test and the erythematous reactions were totally reversible between the 4th and the 7th day of the test.
On the cutaneous aspect, the skin recovered a normal aspect, between the 5th and the 11th day of the test.

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.A7286	Animal no.A7303	Animal no.A7304
Erythema and eschar	1 h	2	2	2
	24 h	2	2	2
	48 h	1	2	2
	72 h	0	1	2
	Day 4	0	0	2
	Day 5	-	0	1
	Day 6	-	0	0
	Day 7	-	0	0
	Day 8	-	0	0
	Day 9	-	0	0
	Day 10	-	0	0
	Mean (24, 48 and 72 h)	1.0	1.7	2.0
Oedema formation	1 h	1	1	1
	24 h	1	1	1
	48 h	0	1	0
	72 h	0	0	0
	Day 4	0	0	0
	Day 5	-	0	0
	Day 6	-	0	0
	Day 7	-	0	0
	Day 8	-	0	0
	Day 9	-	0	0
	Day 10	-	0	0
	Mean (24, 48 and 72 h)	0.3	0.7	0.3

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Under the test conditions, test substance is not classified as irritating to skin according to the criteria 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, undiluted test substance was applied at the dose of 0.5 mL, under semiocclusive dressing during 4 hours on an undamaged skin area of 3 rabbits. On the opposite flank an untreated area was served as the control. Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48, 72 h and Days 4 to 10 after the 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.

 

24 hours after the test item application, it was noted a well definite erythema, associated with a very slight oedema. The oedematous reactions were totally reversible between the 3rd and the 4th day of the test and the erythematous reactions were totally reversible between the 4th and the 7th day of the test. On the cutaneous aspect, the skin recovered a normal aspect, between the 5th and the 11th day of the test.The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 / 1.7 / 2.0 for erythema and 0.3 / 0.7 / 0.3 for oedema. 

 

Under the test conditions, the test substance is not classified according to the criteria 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.