Bis(2-ethylhexyl)amine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05. Jun 1967 - 13. Jun 1967

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable well documented report which meets basic scientific princples.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1967

Report date:

1967

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

BASF-Test:
Four animals were treated for 1, 5, 15 min or 20 hours 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. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 and 72 hours from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl)amine

EC Number:

203-372-4

EC Name:

Bis(2-ethylhexyl)amine

Cas Number:

106-20-7

Molecular formula:

C16H35N

IUPAC Name:

bis(2-ethylhexyl)amine

Details on test material:

- Name of test material (as cited in study report): di-(2-aethylhexyl)-amin
- Analytical purity: > 99 %

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3.1 kg (mean)

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

no data

Duration of treatment / exposure:

1, 5, 15 min or 20 h

Observation period:

8 days

Number of animals:

4

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): concentrated Lutrol and 50% Lutrol
- Time after start of exposure: 1min, 5 min, 15 min and 20 h, respectively

SCORING SYSTEM: The original BASF grading was converted into the numerical grading according to the OECD Draize system.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal 1-4

Time point:

24/48/72 h

Score:

2.7

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal 1-4

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible

Remarks:

8 days

Results 3

Irritation parameter:

other: necrosis

Basis:

animal: 1-4

Time point:

24/48/72 h

Remarks on result:

other: 15 min treatment: full thickness necrosis (1/4 animals): 7 and 8 days after treatment; necrosis - not full thickness (2/4): 6, 7 and 8 days after treatment and 7 and 8 days after treatment, respectively

Irritant / corrosive response data:

Exposure times of 1, 5 and 15 min caused reddening of the dorsal rabbit skin and severe edema beyond the area of exposure. One week later slight reddening (score 2), rhagades and slight necrosis (1 min and 5 min exposures: not full thickness necrosis), severe necrosis (15 min exposure: full thickness necrosis) and induration of the application site were observed. An application of undiluted bis(2-ethylhexyl)amine, 20 h exposure, led to slight reddening, severe edema and severe necrosis (full thickness necrosis). After 8 days, severe necrosis (full thickness necrosis) and induration of the application site were observed. For details see tables below.

Any other information on results incl. tables

Erythema and edema scores for each animal:

Exposition:	1 min			Comment
Animal	Reading	Erythema	Edema
1	1 min	0	0
2	1 min	2	0
3	1 min	2	0
4	1 min	1	2
1	24 h	3	0	bleedings
2	24 h	3	2
3	24 h	4	3	bleedings
4	24 h	3	3
1	48 h	3	0	bleedings
2	48 h	/	/	not examined
3	48 h	/	/	not examined
4	48 h	3	2	bleedings
1	72 h	2	0
2	72 h	/	/	not examined
3	72 h	/	/	not examined
4	72 h	2	2	bleedings
1	8 days	0	0	necrosis (not full thickness), fissures
2	8 days	3	0
3	8 days	0	0	necrosis (not full thickness), induration
4	8 days	2	0	bluish with yellow regions, induration
mean (animal 1 & 4)*	24 - 48 - 72 h	2.7	1.2
*no mean calculation possible for animals 2 and 3, because scores on the 48 or 72 h readings are missing
Exposition:	5 min			Comment
Animal	Reading	Erythema	Edema
1	5 min	0	0
2	5 min	2	0
3	5 min	2	0
4	5 min	1	2
1	24 h	3	0	bleedings
2	24 h	3	2
3	24 h	3	3
4	24 h	3	3
1	48 h	3	0	bleedings
2	48 h	/	/	not examined
3	48 h	/	/	not examined
4	48 h	2	2	bleedings
1	72 h	2	0
2	72 h	/	/	not examined
3	72 h	/	/	not examined
4	72 h	2	0
1	8 days	0	0	necrosis (not full thickness), fissures
2	8 days	3	2	necrosis (not full thickness)
3	8 days	0	0	anemic necrosis (not full thickness), induration
4	8 days	2	0	bluish with yellow regions, induration
mean (animal 1 & 4)*	24 - 48 - 72 h	2.5	0.8
*no mean calculation possible for animals 2 and 3, because scores of the 48 or 72 h readings are missing
Exposition:	15 min			Comment
Animal	Reading	Erythema	Edema
1	15 min	1	2
2	15 min	3	0
3	15 min	2	0
4	15 min	1	2
1	24 h	3	0	bleedings
2	24 h	3	3
3	24 h	3	3	bleedings
4	24 h	3	3
1	48 h	3	0	bleedings
2	48 h	/	/	not examined
3	48 h	/	/	not examined
4	48 h	2	2	bleedings
1	72 h	3	3	bleedings
2	72 h	/	/	not examined
3	72 h	/	/	not examined
4	72 h	2	2	bleedings
1	8 days	0	0	full thickness necrosis, induration
2	8 days	0	0	necrosis (not full thickness), induration
3	8 days	0	0	anemic necrosis (not full thickness), induration
4	8 days	2	0	bluish with yellow regions, induration
mean (animal 1 & 4)*	24 - 48 - 72 h	2.7	1.7
*no mean calculation possible for animals 2 and 3, because scores of the 48 or 72 h readings are missing
Exposition:	20 h			Comment
Animal	Reading	Erythema	Edema
1	24 h	2	3	bleedings
2	24 h	3	3	induration
3	24 h	2	3	anemic, necrosis (not full thickness)
4	24 h	0	3	full thickness necrosis
1	48 h	2	3	bleedings
2	48 h	/	/	not examined
3	48 h	/	/	not examined
4	48 h	0	3	anemic
1	72 h	2	2	anemic necrosis (not full thickness)
2	72 h	/	/	not examined
3	72 h	/	/	not examined
4	72 h	2	2	full thickness necrosis
1	8 days	2	0	anemic necrosis (not full thickness), bluish with yellow regions, induration
2	8 days	2	0	full thickness necrosis
3	8 days	3	0	full thickness necrosis, induration
4	8 days	0	0	full thickness necrosis, induration, fissures
mean (animal 1 & 4)*	24 - 48 - 72 h	1.3	2.7
*no mean calculation possible for animals 2 and 3, because scores of the 48 or 72 h readings are missing

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Conclusions:

Due to the appearance of full thickness necrosis on day six after treatment (exposure period 15 min) lasting until the end of the observation period of eight days, it can be concluded that the test substance has a corrosive potential.

Executive summary:

Four animals were treated for 1, 5, 15 min or 20 hours 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. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 and 72 hours from the raw data were taken into account. Due to the appearance of full thickness necrosis on day six after treatment (exposure period 15 min) lasting until the end of the observation period of eight days, it can be concluded that the test substance has a corrosive potential.