N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study was not conducted in compliance with GLP, but is well documented and sufficient to cover this endpoint (conduction close to OECD 404).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

24 hour exposure, occlusive

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

EC Number:

252-899-6

EC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Cas Number:

36177-92-1

Molecular formula:

C13H28N2

IUPAC Name:

N-butyl-2,2,6,6-tetramethylpiperidin-4-amine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.4 - 2.6 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50-60%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 1%

Duration of treatment / exposure:

24 hours

Observation period:

24 and 72 hours

Number of animals:

6

Details on study design:

Prior to treatment the hair was closely clipped off from the back of the animals. On each of the rabbits two areas of the back ware designated for the position of the patches. One of the areas was abraded by making epidermal incisions. The patches consisted of two 2.5 cm squares of double layer
light gauze and were secured to the test areas by adhesive tape.
A volume of 0.5 ml of the diluted test compound has been applied under each of the patches. The entire trunk of the rabbits was wrapped in a rubber
sleeve and the animals were immobilized for 24 hours in wooden stocks. 24 hours after application the patches were removed and the resultIng
reactions scored according to the Draize's scale.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Within 24 hours after application very slight erythema of both abraded and intact skin was observed in four animals. At the 72-evaluation this skin alteration were absent. The primary irritation index was 0.34 and therefore the test item is not considered to be irritating to the skin.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

A 1% aqueous solution of "CHR 5" has been evaluated in the primary skin irritation test in rabbits. Under the described conditions of this study in the rabbit the test item was not irritating to the skin.