N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 Jan 1985 - 24 Jan 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

EC Number:

262-679-1

EC Name:

N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

Cas Number:

61260-55-7

Molecular formula:

C24H50N4

IUPAC Name:

N1,N6-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine

Test animals

Species:

rabbit

Strain:

other: Kleinrussen Chbb-SPF

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa. Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1-2.5 kg
- Housing: individually in stainless steel cages
- Diet (ad libitum): K4 Alleindiät for rabbits, Ssniff Spezialfutter GmbH, 4770 Soest, ad libitum
- Water (ad libitum): tap water ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: paraffin oil for humidification

Controls:

other: the untreated sites of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6 (3 males and 3 females)

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: polyethylene foil with an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: rinsed with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1-6

Time point:

other: mean over 24, 48, 72 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

edema score

Basis:

animal: #1-4

Time point:

other: mean over 24, 48, 72 hours

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 3

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: mean over 24, 48, 72 hours

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: mean over 24, 48, 72 hours

Score:

3.7

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Test substance showed severe irritating effects on male and female rabbit skin. Necrosis (full thickness) appeared after 4 hours, but not after 3 minutes. See also Table 1 (Any other information on results)

Any other information on results incl. tables

Table 1. Evaluation of sin reactions, individual scores (Draize) and observations.

 

Animal #	Sex	Reading time point post-exposure
		1h		24 h		48 h		72 h
		Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	M	4 (1)	4	4 (1)	4	4 (2,3,4)	4	4 (1,4,5)	4
2	M	4 (1)	2	4 (1)	4	4 (1,3,4)	4	4 (1,5)	4
3	M	4 (1)	3	4 (1)	4	4 (1)	4	4 (1,5)	4
4	F	4 (1,2)	4	4 (1)	4	4 (1,3,4)	4	4 (1,4,5)	4
5	F	4 (1, 2)	3	4 (1)	2	4 (1,3,4)	4	4 (1,4,5)	4
6	F	4 (1)	4	4 (1)	4	4 (1)	4	4 (1,5)	3

 

1: Bloody necrosis and strong green colour

2: Necrosis, green colour at the edges of the application site

3: Application site hardened

4: Deep wounds

5: Scab

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Under the experimental conditions described, the test substance fulfils the GHS criteria for classification as corrosive (Category 1C).