2H-Pyran, tetrahydro-3-(phenylmethyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 to 21 December, 2004

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. The substance is considered to be adequately characterised.

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:

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

Test material

Test material information

Constituent 1

Reference substance name:

(3R)-3-benzyloxane

Molecular formula:

C12 H16 O

IUPAC Name:

(3R)-3-benzyloxane

Constituent 2

Reference substance name:

(3S)-3-benzyloxane

Molecular formula:

C12 H16 O

IUPAC Name:

(3S)-3-benzyloxane

Test material form:

liquid

Remarks:

clear

Details on test material:

- Physical state: Colourless translucent liquid, characteristic odour
- Storage conditions : room temperature

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 - FRANCE
- Weight at study initiation: 2.24-2.60 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: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-21 °C
- Humidity: 28-54 %

IN-LIFE DATES: 14 to 21 December, 2004

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Remarks:

undamaged skin area

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:

1 hour and then 24, 48, 72 hours and Days 4 after removal of the patch.

Number of animals:

3 males

Details on study design:

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 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

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:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

probability of weak 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:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Remarks on result:

probability of weak 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:

Twenty four hours after the test product application, it was noted, on the treated area, a slight to moderate erythema. These erythematous reactions were totally reversible between the 3rd and the 5th day of the test.
On the cutaneous structure, it was noted a dryness between the 3rd and 6th day of the test in one animal, between the 4th and the 6th day in a second one and between the 4th and the 7th day in the last one. The skin recovered a normal aspect between the 7th and the 8th 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		Scores
Skin reactions	Observation time	Animal No. A6365	Animal No. A6371	Animal No. A6372
Erythema	1h	0	1	1
	24h	1	2	1
	48h	1	1	0
	72h	1	0	0
	Day 4	0	-	-
	Mean 24/48/72h	1	1	0.3
Oedema	1h	0	0	0
	24h	0	0	0
	48h	0	0	0
	72h	0	0	0
	Day 4	0	0	0
	Mean 24/48/72h	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

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 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 Day 4 after the removal of the patch.

 

Twenty four hours after the test product application, it was noted, on the treated area, a slight to moderate erythema. These erythematous reactions were totally reversible between the 3rd and the 5th day of the test.

On the cutaneous structure, it was noted a dryness between the 3rd and 6th day of the test in one animal, between the 4th and the 6th day in a second one and between the 4th and the 7th day in the last one. The skin recovered a normal aspect between the 7th and the 8th day of the test.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 1.0 / 1.0 / 0.3 for erythema and 0.0 / 0.0 / 0.0 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 to the GHS.

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