N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline conform GLP study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

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

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: E.S.D. (Chatillon-sur-Chalaronne, France)
- Age at study initiation: 3 months
- Weight at study initiation: 2 - 3 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): 150 g/animal/d of pelleted complete rabbit diet (diet reference 112 C-10 Usine d'Alimentation Rationnelle, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): softened and filtered mains drinking water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 +/- 3 °C
- Humidity (%): >/= 45%
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

- Preparation of exposure area
at least the day before application of the test item, the back and the flanks of the rabbits were carefully clipped. At the time of application, only the animals showing a healthy intact skin, with no evidence of macroscopic irritation were used in the study.

-Method of administration
The test item was applied under a semi-occlusive dressing composed of a gauze pad approx. 2.5 cm x 2.5 cm, maintained in contsct with the skin with a perforated tape. This tape was applied on a crimped gauze bandage which fully covered the clipped area to avoid possible irritation reactions and was wrapped around the animal without blocking the respiratory and abdominal movements.
The powder was moistened with water for injection to obtain a homogeneous paste.

SCORING SYSTEM:

Erythema and eschar formation
No erythema.......................................................................................................................0
very slight erythema (barely perceptible)......................................................................1
well-defined erythema......................................................................................................2
moderate to severe erythema..........................................................................................3
severe erythema (beet redness) to slight eschar formation (lesion in depth).........4

Oedema
No oedema...................................................................................................................................0
very slight oedema (barely perceptible)..................................................................................1
slight oedema (edges of area well defined by definite raising)............................................2
moderate oedema (raised approximately 1mm)....................................................................3
severe oedema (raised more than 1mm and extending beyond area of exposure.........4

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

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 5

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Mean erythema score (all animals; 24, 48 and 72 h): 0.1; fully reversible within 48 h
Mean edema score (all animals; 24, 48 and 72 h): 0

Other effects:

No effects observed

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

With reference the reported scores and the full reversibility of effects within 48 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).

Executive summary:

N,N’-Bis(2,2,6,6-tetramethyl-4-piperidinyl)isophthalamide was tested for its skin irritant properties in 3 New Zealand White rabbits. The study was performed according to OECD Guideline 404.

With reference the reported scores and the full reversibility of effects within 48 h the test item does not have to be classified as irritant to the skin according to the criteria laid down in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).