Hexanoic acid, 3,5,5-trimethyl-, 2,2,6,6-tetramethyl-1-[2-[(3,5,5-trimethyl-1-oxohexyl)oxy]ethyl]-4-piperidinyl ester

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well documented, according to OECD guideline and GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate

EC Number:

941-267-1

Cas Number:

1445870-18-7

Molecular formula:

C29H55NO4

IUPAC Name:

2-{2,2,6,6-tetramethyl-4-[(3,5,5-trimethylhexanoyl)oxy]piperidin-1-yl}ethyl 3,5,5-trimethylhexanoate

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 3-4 months
- Weight at study initiation: 3.33 kg – 3.64 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/ - 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated skin sites of the same animal.

Amount / concentration applied:

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

Duration of treatment / exposure:

4h

Observation period:

Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals up to day 14.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol® E 400 (= Polyethylenglycol, BASF SE) and Lutrol® / water (1 : 1).

SCORING SYSTEM: according to the quoted guidelines

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.3

Max. score:

4

Reversibility:

not fully reversible within: 14 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

The first animal revealed very slight erythema (grade 1) immediately after removal of the patch until 1 hour after removal of the patch and was free of local skin reactions until hour 48. Thereafter, very slight erythema was observed again at hour 72. This finding increased to moderate erythema (grade 3) and slight edema (grade 2) on day 7. Both findings were noted beyond the application area on day 7. In addition, a yellowish to whitish discolored application area was seen on day 7. On day 14 scaling without any erythema was noted in this animal.
The second animal revealed very slight erythema (grade 1) immediately after removal of the patch until 1 hour, which increased to well-defined erythema (grade 2) at hour 24, but regressed to very slight erythema from hour 48 until hour 72. Thereafter, well-defined erythema was seen again on study day 7, which decreased finally to very slight erythema on day 14. From hour 24 until day 7, erythema was noted beyond the application area.
The third animal revealed very slight erythema at hour 1 after removal of the patch. This finding increased to well-defined erythema from hour 24 until hour 72. On day 7, very slight erythema was noted again. From hour 24 until day 7, erythema was noted beyond the application area, while scaling was seen on day 7.

The cutaneous reactions were reversible in one animal within 14 days after removal of the patch. In the other two animals, very slight erythema or scaling only were still noted at study termination on day 14.

Mean scores over 24, 48 and 72 hours for each animal were 0.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for edema.

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Remarks:

Criteria used for interpretation of results: EU