4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 18, 1992 - August 25, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant Guideline study (OECD)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Remarks:

Short-term Toxicology CIBA-GEIGY Limited

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol

EC Number:

258-132-1

EC Name:

4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol

Cas Number:

52722-86-8

Molecular formula:

C11H23NO2

IUPAC Name:

1-(2-hydroxyethyl)-2,2,6,6-tetramethylpiperidin-4-ol

Details on test material:

- Physical state: solid; white
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GMBH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss
- Weight at study initiation: 2480 to 2510 g
- Housing: individually in metal cages
- Diet: ad libitum standard rabbit pellet - Nafag No. 814
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80

Controls:

other: untreated flank

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48, 72 hours, 7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: right flank
- Type of wrap if used: The patches were loosely covered with an aluminium foil (approx. 36 square cm ) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).

SCORING SYSTEM: according to OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.6

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.1

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

The test item caused minimal to slight erythem and edem visible in all animals 1h after removal of the patches. All effects were reversible withing 72 hours the latest.

Any other information on results incl. tables

Individual skin reaction scores:

reading	animal	Erythema	Edema
1h	1	2	1
	2	2	1
	3	2	1
24h	1	2	1
	2	1	0
	3	1	0
48h	1	1	0
	2	0	0
	3	0	0
72h	1	0	0
	2	0	0
	3	0	0
7 d	1	0	0
	2	0	0
	3	0	0
mean 24-72h	1	1	0.33
	2	0.33	0
	3	0.33	0
mean 24-72h		0.6	0.1

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the experimental conditions employed the test item induced erythema and edema reactions below the threshold of significance. Therefore, the test item can be classified as non-irritant.