2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

BASF-Test: Two animals were treated for 1, 5 and 15 min using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5, 15 min) the skin was washed with Lutrol (50%). The animals were observed for 14 days and skin changes were recorded daily.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

EC Number:

229-962-1

EC Name:

2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)

Cas Number:

6864-37-5

Molecular formula:

C15H30N2

IUPAC Name:

4-[(4-amino-3-methylcyclohexyl)methyl]-2-methylcyclohexan-1-amine

Test animals

Species:

rabbit

Strain:

not specified

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

other: unchanged or olive oil

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): undiluted or as 30% solution in olive oil

Duration of treatment / exposure:

1, 5 and 15 min

Observation period:

14 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5x2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: skin was washed with Lutrol (conc.) and Lutrol/water (1:1).
- Time after start of exposure: After the 1, 5 and 15 min exposure time.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

1 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: score for undiluted test substance

Results 2

Irritation parameter:

erythema score

Remarks:

5 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: score for undiluted test substance

Results 3

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

mean

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: score for undiluted test substance

Irritant / corrosive response data:

The test substance, undiluted or as a 30% preparation and applied for 1, 5 or 15 minutes, produced inflammatory erythema followed by desquamation. After application for 15 minutes, slight edema and scaling was observed, additionally. The skin was normal at 14 days after application.

Any other information on results incl. tables

Mean erythema scores (animal 1/2), undiluted test substance:

Exposure time	same day	24 h	48 h	72 h	8 days	14 days
1 min	1/1	0/0	0/1	0/2	0/1	0/0
5 min	2/2	0/1	2/1	1/1	S/1	0/0
15 min	2/2	2/2	2/2	2/2	S/2	0/0

Mean erythema scores (animal 1/2), 30% dilution of test substance:

Exposure time	same day	24 h	48 h	72 h	8 days	14 days
1 min	0/0	0/1	2/1	0/0	S/0	0/0
5 min	0/0	0/0	2/1	0/0	S/0	0/0
15 min	0/0	1/0	2/2	1/1	S/S	0/0

S: scales

The original BASF grading was converted into the numerical grading according the OECD Draize system.

The test substance, undiluted or as a 30% preparation and applied for 1, 5 or 15 minutes, produced inflammatory erythema followed by desquamation. After application for 15 minutes, slight edema and scaling was observed, additionally. The skin was normal at 14 days after application.