2-ethyl-N,N-bis(2-ethylhexyl)hexylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Remarks:

limited documentation, only 2 animals used, 72-hrs reading missing, observation period only 8 days

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Reference 2

Reference Type:

other company data

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Principles of method if other than guideline:

Two animals were treated for 1, 5, 15 min or 20 h using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the liquid test substance. The animals were observed for 8 days and skin changes were recorded daily. For a final evaluation, the findings from 24 and 48 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethyl-N,N-bis(2-ethylhexyl)hexylamine

EC Number:

217-461-0

EC Name:

2-ethyl-N,N-bis(2-ethylhexyl)hexylamine

Cas Number:

1860-26-0

Molecular formula:

C24H51N

IUPAC Name:

tris(2-ethylhexyl)amine

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Tri-2-Aethylhexylamin
- Physical state: liquid
- Analytical purity: approx. 98%

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.11 and 3.57 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL

Duration of treatment / exposure:

1min, 5 min, 15 min and 20 h, respectively

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5*2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): conc. Lutrol and 50 % Lutrol solution
- Time after start of exposure: 1, 5 or 15 min post exposure

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

1 min exposure

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling at study termination.

Results 2

Irritation parameter:

erythema score

Remarks:

1 min exposure

Basis:

animal #2

Time point:

24/48 h

Score:

1.5

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling at study termination.

Results 3

Irritation parameter:

erythema score

Remarks:

5 min exposure

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling at study termination.

Results 4

Irritation parameter:

erythema score

Remarks:

5 min exposure

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling at study termination.

Results 5

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

animal #1

Time point:

24/48 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling at study termination.

Results 6

Irritation parameter:

erythema score

Remarks:

15 min exposure

Basis:

animal #2

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling at study termination.

Results 7

Irritation parameter:

edema score

Remarks:

1, 5 and 15 min exposure

Basis:

mean

Remarks:

animal 1-2

Time point:

24/48 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

animal #1

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling extending beyond the area of application at study termination.

Results 9

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

animal #2

Time point:

24/48 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Erythema extending beyond the area of application; scaling extending beyond the area of application at study termination.

Results 10

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 11

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Table 1: Mean erythema score after 24 and 48 h (72 h reading is missing)

Exposure time	24 h		48 h		72 h		mean
	animal 1	animal 2	animal 1	animal 2	animal 1	animal 2	animal 1	animal 2
1 min	2	1	2	2	-	-	2	1.5
5 min	2	1	2	1	-	-	2	1
15 min	2	1	2	1	-	-	2	1
20 h	2	2	3	3	-	-	2.5	2.5

Table 2: Mean edema score after 24 and 48h (72 h reading is missing)

Exposure time	24 h		48 h		72 h		mean
	animal 1	animal 2	animal 1	animal 2	animal 1	animal 2	animal 1	animal 2
1 min	0	0	0	0	-	-	0	0
5 min	0	0	0	0	-	-	0	0
15 min	0	0	0	0	-	-	0	0
20 h	0	0	2	0	-	-	1	0

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

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

After exposure times of 1, 5, 15 min and 20 h the test material caused slight to moderate reddening of the dorsal rabbit skin extending beyond the area of exposure. After 20 h of exposure 1 animal showed slight edema after 48 h. At the end of the observation period of 8 days the animals showed at all exposure times scale formation which was extending beyond the area of exposure in the 20 h application. According to the criteria laid down in the Regulation (EC) No. 1272/2008, the substance does not need to be classified and labeled as skin irritating.