2,2,6,6-tetramethyl-4-substituted-piperidinyl-1-oxy

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study performed to GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Annex V

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

other: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: David Percival Ltd
Environmental conditions:
Housed individually in suspended solid floor cages.
Temperature: 17-23ºC
humidity: 30-70%
Acclimitisation period: 5 days
Air changes: 15 per hour
Lighting: 12 hours continuous light and twelve hours darkness
Free access to mains drinking water and food

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: None

Controls:

not specified

Amount / concentration applied:

0.5 ml under a 2.5 x 2.5 cm cotton gauze.

Duration of treatment / exposure:

4 h

Observation period:

Approximatley one hour following the removal of the patches and 24, 48 and 72 hours later, the test sites were observed for evidence of primary irritation and scored.

Number of animals:

3

Details on study design:

On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interferring with the patches, the trunk of each animal was wrapped in an elasticated corset and the animals were returned to their cages.
Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean score 1)

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean score 2)

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean score 3)

Time point:

24/48/72 h

Score:

0.66

Reversibility:

fully reversible within: 7 d

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 7 days

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The test material produced a primary irritation index of 1.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

A GLP study was performed in accordance with OECD 404 in order to assess the irritancy potential of Inhibitor AHM P500 to the skin of the New Zealand White Rabbit. 

On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5 ml of the test material was introduced under a 2.5 x 2.5 cm cotton gauze patch and placed in position on shorn skin. The patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of each animal was wrapped in an elasticated corset and the animals returned to their cages.

Four hours after application, the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

The single 4-hour semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Slight desquamation was also noted. One treated skin site appeared normal at the 7-day observation.

The test material produced a primary irritation index of 1.8 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

.