(1-λ1-oxidanyl-2,2,6,6-tetramethylpiperidin-4-yl) benzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

In vivo study previously available which addresses fully the endpoint requirements.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-03-02 to 1995-03-30

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study (OECD 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, May 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-hydroxy-2,2,6,6-tetramethylpiperidinoxyl

EC Number:

218-760-9

EC Name:

4-hydroxy-2,2,6,6-tetramethylpiperidinoxyl

Cas Number:

2226-96-2

Molecular formula:

C9H18NO2

IUPAC Name:

2,2,6,6-tetramethylpiperidine-1,4-diol

Test material form:

solid: flakes

Test animals

Species:

rabbit

Strain:

other: "Kleine Weiße Russen, Chbb:HM, SPF"

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik, 88400 Biberach an der Riss 1, Germany
- Age at study initiation: adults
- Weight at study initiation: 2.5, 2.6 and 2.5 kg
- Housing: conventional, kept single in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity:30 - 70 %
- Air changes: 15 per h
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 1995-03-06 To: 1995-03-10

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g in 0.5 cm³ water

Duration of treatment / exposure:

4 hours

Observation period:

30 to 60 min, 24, 48 and 72h

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk
- Coverage: approximately 6 cm²
- Type of wrap if used: gauze, covered by non irritating patch and semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes, warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize / Guideline OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(mean)

Time point:

other: 24, 48 and 72h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(mean)

Time point:

other: 24, 48 and 72h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(mean)

Time point:

other: 24, 48 and 72h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(mean)

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(mean)

Time point:

other: 24, 48 and 72h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(mean)

Time point:

other: 24, 48 and 72h

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Executive summary:

The skin irritation/corrosion of 4-Hydroxy-TEMPO was tested in a standard OECD 404 guideline study. Classification: not irritating.