6,8-dimethylnon-7-enal

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

16 October to 02 November 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP study conducted in compliance with OECD Guideline No. 404 without any deviation. The substance is adequately identified, but details on composition are missing. Therefore validation applies with restrictions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

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:

no

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:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

11 January 2007.

Test material

Test material information

Constituent 1

Reference substance name:

7-nonenal, 6,8-dimethyl-, (6S)

Cas Number:

899810-99-2

Molecular formula:

C11 H20 O

IUPAC Name:

7-nonenal, 6,8-dimethyl-, (6S)

Constituent 2

Reference substance name:

7-nonenal, 6,8-dimethyl-,(6R)-

Cas Number:

899810-91-4

Molecular formula:

C11 H20 O

IUPAC Name:

7-nonenal, 6,8-dimethyl-,(6R)-

Test material form:

liquid

Details on test material:

- Physical state: colourless translucent liquid
- Storage condition of test material: 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).
- Weight at study initiation: 2.54-3.33 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SDS - C15), ad libitum
- Water: tap-water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18-24 °C
- Humidity: 19-70 %
- Air changes: between ten and fifteen changes per hour.
- Photoperiod: 12 hours light/12 hours dark.

IN-LIFE DATES: from16 October to 02 November 2007

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

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

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 (in case of persistent reactions were observed).

Number of animals:

3 females

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 (in case of persistent reactions were observed).

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:

2

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of mild irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean individual score

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 6 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:

1.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of mild 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: 6 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:

1.7

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

probability of mild irritation

Irritant / corrosive response data:

It was noted, 1 hour after the test item application, on the treated area, a well defined erythema associated with a slight oedema. The oedematous reactions were totally reversible at D6 and the erythematous reactions were totally reversible between D6 and D8. On the cutaneous structure, a dryness was noted on the treated area, from D3 in two animals and from D6 in the last one. The skin recovered a normal aspect between D9 and D10 in two animals but a slight dryness was still registered the last day of the test (D14) in one animal.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Individual and mean skin reactions/Erythema - Eschar formation following 4 hour exposure

Skin reaction	Observation time (following patch removal)	Individual Scores – Rabbit Number and Sex
		A8517/Female	A8546/Female	A8547/Female
Erythema/Eschar formation	1 h	2	2	2
	24 h	2	2	2
	48 h	2	2	2
	72 h	2	2	2
	Day 6	1	0	0
	Day 7	1	0	0
	Day 8	0	0	0
	Total (24, 48 and 72 hours)	6	6	6
	Mean (24, 48 and 72 hours)	2	2	2

Table 7.3.1/2: Individual and mean skin reactions/Oedema formation following 4 hour exposure

Skin reaction	Observation time (following patch removal)	Individual Scores – Rabbit Number and Sex
		A8517/Female	A8546/Female	A8547/Female
Oedema formation	1 h	2	2	2
	24 h	2	2	2
	48 h	2	2	2
	72 h	2	1	1
	Day 6	0	0	0
	Day 7	0	0	0
	Day 8	0	0	0
	Total (24, 48 and 72 hours)	6	6	6
	Mean (24, 48 and 72 hours)	2	1.7	1.7

Note:

A8517: slight dryness D13 to D14, dryness between D4 to D10

A8546: slight dryness D3 & between D7 to D8, dryness at D6

A8547: slight dryness D3 & between D7 to D8, dryness at D6 & D7

Applicant's summary and conclusion

Interpretation of results:

Category 3 (mild irritant) based on GHS criteria

Conclusions:

Under the test conditions, the test material is not classified as irritant to the skin according to the annex I of the Regulation (EC) No. 1272/2008 (CLP) and clasified 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, 0.5 mL of undiluted test item was applied on an undamaged skin area of the flank of 3 female New Zealand White rabbits. On the other 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 and observations were continued from Days 4 to 14. 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 noted, 1 hour after the test item application, a well defined erythema associated with a slight oedema. The oedematous reactions were totally reversible at D6 and the erythematous reactions were totally reversible between D6 and D8. Dryness was noted on the treated area, from D3 in two animals and from D6 in the last one. The skin recovered a normal aspect between D9 and D10 in two animals but a slight dryness was still registered the last day of the test (D14) in one animal.

 

The mean scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.0/2.0 /2.0 for erythema and 2.0 / 1.7 / 1.7 for oedema. These effects are reversible between days 6 and 8.

 

Therefore, the test material is not classified as irritant to the skin according to the annex I 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.