2,2,5-trimethyl-5-pentylcyclopentan-1-one

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From July 03 to 12, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study conducted in compliance with OECD Guideline No. 404 without any deviations.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

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:

inspected on September 22, 1999/signed on January 18, 2000

Test material

Test material information

Constituent 1

Reference substance name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

EC Number:

265-779-3

EC Name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

Cas Number:

65443-14-3

Molecular formula:

C13H24O

IUPAC Name:

2,2,5-trimethyl-5-pentylcyclopentan-1-one

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): ST 13 C 01
- Physical state: Colourless liquid
- Storage condition of test material: Stored at room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France.
- Weight at study initiation: Mean body weight: 2.8 ± 0.1 kg
- Housing: Animals were housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm).
- Diet: 110 pelleted diet (UAR, Villemoisson, Epinay sur-Orge, France), ad libitum
- Water: Drinking water (filtered by a FG Millipore membrane (0.22 µm)), ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12 h dark/ 12 h light

IN-LIFE DATES: From: July 03, 2001 To: July 12, 2001

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin served as 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, 24, 48 and 72 h after patch-removal. Since there was a persistent irritation reaction at 72 h, the observation period was extended up to their complete reversibility (Day 10).

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: Right flank
- Type of wrap if used: Test substance was placed on the gauze pad and held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No; no residual test substance was observed on removal of the dressing.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scale, as described in OECD Guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean 24, 48 and 72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 10 days

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: Mean 24, 48 and 72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: Mean 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: Mean 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: Mean 24, 48 and 72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: Mean 24, 48 and 72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 h

Irritant / corrosive response data:

- A well-defined erythema (grade 2), in addition to a slight oedema (grade 2), was observed on Day 1 in all the animals.
- A well-defined erythema (grade 2) persisted in 1/3 animals from Day 2-6; a very slight erythema (grade 1) was then noted until Day 9. A very slight oedema (grade 1) was also observed on Day 2. In both remaining animals, a very slight erythema (grade 1) was recorded from Day 2-6.
- A dryness of the skin was observed in all the animals from Day 4 (two animals) or 7 to Day 9. Crusts were also noted in 1/3 animals on Days 5 and 6.

Other effects:

None

Any other information on results incl. tables

Table 7.3.1/1: Mean skin irritant/corrosive response data for each animal at each observation time up to removal of animals from the test

Score at time point	Erythema (Animal No. 1 / 2 / 3) Max. score 4	Oedema (Animal No. 1 / 2 / 3) Max. score 4	Other (Animal No. 1 / 2 / 3)
1 h	2/2/2	2/2/2	*/*/*
24 h	2/1/1	1/0/0	*/*/*
48 h	2/1/1	0/0/0	*/*/*
72 h	2/1/1	0/0/0	*/S/S
Day 5	2/1/1	0/0/0	*/SA/S
Day 6	2/1/1	0/0/0	*/SA/S
Day 7	1/0/0	0/0/0	S/S/S
Day 8	1/0/0	0/0/0	S/S/S
Day 9	1/0/0	0/0/0	S/S/S
Day 10	0/0/0	0/0/0	*/*/*
Average 24, 48 and 72 h	2/1/1	0.3/0/0	-
Reversibility	Completely reversible	Completely reversible	-
Average time for reversion	10 days	48 h	-

 

Keys: * None; S= Dryness of the skin; A= Crust

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

In a dermal irritation study performed according to the OECD Guideline No. 404, and in compliance with GLP, 0.5 mL of the undiluted test material was applied on the clipped skin of the right flank area of three male New Zealand White rabbits. The test material was held in contact with the skin by means of a semi-occlusive dressing for 4 h. The untreated skin served as control. Cutaneous reactions were assessed and scored according to the Draize scale at 1, 24, 48 and 72 h after removal of the dressing and then daily until reversibility of cutaneous reactions (Day 10).

A well-defined erythema, in addition to a slight oedema, was observed on Day 1 in all the animals. A well-defined erythema persisted in 1/3 animals from Day 2-6; a very slight erythema was then noted until Day 9. A very slight oedema was also observed on Day 2. In both remaining animals, a very slight erythema was recorded from Day 2-6. A dryness of the skin was observed in all the animals from Day 4 (two animals) or 7, to Day 9. Crusts were also noted in 1/3 animals on Days 5 and 6.

The individual scores for each animal within 3 scoring times (24, 48 and 72 h) were 2.0 / 1.0 / 1.0 for erythema and 0.3 / 0.0 / 0.0 for oedema.

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

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