1-Butanone, 3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-, rel-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 25 May 2004 to 28 May 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study performed according to OECD test guideline No. 404 and in compliance with GLP

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

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

Principles of method if other than guideline:

not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Compliance Programme (inspected on 2002-12-02)

Test material

Test material information

Constituent 1

Reference substance name:

(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Constituent 2

Reference substance name:

(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Constituent 3

Reference substance name:

(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Constituent 4

Reference substance name:

(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Molecular formula:

C25 H46 O S

IUPAC Name:

(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone

Test material form:

liquid

Details on test material:

- Physical state: white solid or Colourless liquid (depending on temperature)

Specific details on test material used for the study:

- Stability under test conditions: stable
- Storage condition of test material: ca. 4°C in the dark under nitrogen

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): free access (Certified Rabbit Diet (Code 5322) supplied by BCM IPS Limited, London, UK)
- Water (e.g. ad libitum): free access
- Acclimation period: at least five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 25 To: 28 May 2004

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

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

VEHICLE (moistened with water)
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: cotton gauze patch secured on position with a strip of surgical adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (gentle swabbing with cotton wool soaked in distilled water)
- Time after start of exposure: 4 hours

SCORING SYSTEM: draize scale, as described in OECD Test Guideline 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

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 5

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 6

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:

Very slight erythema was noted at all treated skin sites one hour after patch removal. Reversibility of any observed effect: Changes fully reversible within 1 day

Other effects:

None

Any other information on results incl. tables

Very slight erythema was noted at all treated skin sites one hour after patch removal. All treated skin sites appeared normal at the 24 -hour observation.

Table 7.3.1: Individual Daily and Mean Scores for Dermal Irritation Following a 4-hour exposure

		Individual Scores – Rabbit Number and sex
Skinreaction	Reading (hours)	1 male	2 male	3 male
Erythema/escharFormation	1 24 48 72	1 0 0 0	1 0 0 0	1 0 0 0
Mean Score (24 -48 -72 h)		0.0	0.0	0.0
Oedema Formation	1 24 48 72	0 0 0 0	0 0 0 0	0 0 0 0
Mean Score (24 -48 -72 h)		0.0	0.0	0.0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the test conditions, test material is not classified as irritant to the skin according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and 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 test material moistened with water was dermally applied on the clipped skin of the dorsal surface of 3 New Zealand White rabbits. Test sites were covered with a semi-occlusive dressing for 4 hours.

Skin irritation was assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after the removal of the patch.

Slight erythema was observed 1 hour following patch removal. The individual scores calculated over all the animals tested within 3 scoring times (24, 48 and 72 h) were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for oedema.

Under the test conditions, test material is not classified as irritant to the skin according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and according to the GHS.

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