Cyclohexanamine, 4,4'-methylenebis[N-(1-methylpropyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 21, 1993 - October 20, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The method is similar to OECD Guideline 404 with acceptable restrictions (more than one test site per animal used, clinical sign not reported, no details of test material). The study was conducted in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

, test material was applied to three separate test areas

Principles of method if other than guideline:

The test material was administered undiluted to three separate test areas on the intact skin on each animal´s back in the amount of 0.5 ml per site. Each area of application was covered with a 1 inch x 1 inch (about 6 m2) gauze path to provide a semi occlusive dressing. Each animal was exposed to the test material for 3 minute, 1 hour and 4 hour periods of time. Collars were not used to restrain the test animal during the exposure periods. The post exposure time was 96 hours and all the animals were euthanized afterwards.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-(butan-2-yl)-4-({4-[(butan-2-yl)amino]cyclohexyl}methyl)cyclohexan-1-amine

EC Number:

679-514-8

Cas Number:

154279-60-4

Molecular formula:

C21H42N2

IUPAC Name:

N-(butan-2-yl)-4-({4-[(butan-2-yl)amino]cyclohexyl}methyl)cyclohexan-1-amine

Details on test material:

- Name of test material (as cited in study report): XPA-143-93 Unilink 4200H (proprietary Aliphatic Diamine).
- Physical state: Clear, colourless liquid.
- 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: Hazelton Research Products, Wisconsin
- Age at study initiation: Adult albino rabbit
- Weight at study initiation: 2 424 - 2 576 g
- Housing: Screen-bottom cages individaully
- Diet: A measured amount of High Fiber Rabbit Chow # 5326.
- Water: Water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
The animals were housed in temperature- and humidity- controlled quarters.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 ml per site of undiluted test substance was applied to three separate test areas on intact skin on animals back.

Duration of treatment / exposure:

Each animal was exposed to the test material for 3 minute, 1 hour and 4 hour periods of time.

Observation period:

Observation period was 96 hours.

Number of animals:

Three males and three females.

Details on study design:

TEST SITE
- Area of exposure: The test material was administered undiluted to three separate test areas on the intact skin on each animal´s back in the amount of 0.5 ml per site.
- Type of wrap if used: Each area of the application was covered with a 1 inch x 1 inch gauze patch (two single layers thick) secured with paper tape, loosely overwrapped and secured with Elastoplast tape to provide a semi occlusive dressing. The wrappings applied to each test site were independent of the other sites.

REMOVAL OF TEST SUBSTANCE
- Washing: The residual test material was removed using water and/or a waterless hand cleaner (GOOP without abrasive) without irritating the skin.
- Time after start of exposure: At the end of the 3 minute, 1 hour and 4 hour exposure periods.

SCORING SYSTEM: Approximately 30 minutes after the patch was removed, the application site was examined for erythema and oedema according to the Draize technique (recorded as the 3 minute, 1 hour and 4 hour score).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 3 minute

Score:

1.5

Max. score:

8

Reversibility:

not reversible

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1 hour

Score:

2.8

Max. score:

8

Reversibility:

not reversible

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 4 hour

Score:

7.3

Max. score:

8

Reversibility:

not reversible

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 3 minute

Score:

1.3

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 hour

Score:

2.5

Max. score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 hour

Score:

3.3

Max. score:

4

Reversibility:

not reversible

Results 7

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 3 minute

Score:

0.2

Max. score:

4

Reversibility:

not reversible

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 hour

Score:

0.3

Max. score:

4

Reversibility:

not reversible

Results 9

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 hour

Score:

4

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Individual dermal irritation scores of this study are presented in tables, which are attached as a background material.

The average primary dermal irritation score is the total dermal irritation score for all the animals (erythema and edema) divided by the number of test sites for each exposure period at each observation period.

Any other information on results incl. tables

Individual dermal irritation scores of this studty are presented in tables, which are attaced as a background material.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The primary dermal irritation/corrosion potential of XPA-143-93 Unilink 4200 H (trade name Clearlink 1000) was evaluated when applied to the skin of rabbits under 3 minute, 1 hour and 4 hour semi occlusive conditions. The test material was applied to three separate test areas on the intact skin on each animal´s back. The method is not based on guideline, but it is similar to OECD 404 with acceptable restrictions (more than one test site per animal used, clinical sing not reported and no details of test material). The study was conducted in compliance with GLP.

Evidence of corrosion (necrotic areas) was observed at two sites that received the 3 minute exposure, and all six sites that received the 1 hour and 4 hour exposures. The study was terminated 96 hours post exposure. Clinical signs were not reported during the study nor were autopsy at the termination. Based on the test results, the test material is considered to be corrosive to the skin of rabbit.

The results of this study would lead to the classification of corrosion (C; R35) in accordance with the criteria set in Directive 67/548/EEC. According to EU Regulation No. 1272/2008 (CLP), the classification would be skin corr. 1A; Causes severe skin burns and eye damage.

The study is classified as acceptable and satisfies the guideline requirements for the skin corrosion study. The result of this study is used as a key value in hazard assessment.