Dipropylamine

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:

other: Meets generally accepted scientific standards, well documented and acceptable ror assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Principles of method if other than guideline:

A 0.5 ml dose of each test article was applied to the appropriate test sites and the dose immediately covered with an 8 ply, 1"x1" square gauze patch secured at the edges with nonirritation tape. Following a 60 second exposure period, the patches were removed and the remaining test article was wiped and/or rinsed from the test sites using different rinsing procedures.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dipropylamine

EC Number:

205-565-9

EC Name:

Dipropylamine

Cas Number:

142-84-7

Molecular formula:

C6H15N

IUPAC Name:

dipropylamine

Details on test material:

- Name of test material (as cited in study report): C-00896 (Di-n-Propylamine)
- Physical state: Clear colorless liquid
- Lot/batch No.: None provided

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Mohican Valley Rabbitry, Loudonville, Ohio
- Age at study initiation: adult
- Weight at study initiation: approximately 2.0 to 3.5 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65-71 F
- Humidity (%): 42-90%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

60 seconds

Observation period:

14 days

Number of animals:

3

Details on study design:

On the day prior to dosing, the fur was clipped from the dorsal area of the trunk of each of twelve test animals.
On the following day, the animals were weighed (weight range 1.9 -2.2 kg). The animals were then placed into 4 groups of three rabbits each and one approximate 1" x 1" test site per test article was chosen within the clipped area on each animal.

For all groups:
A 0.5 ml dose of each test article was applied to the appropriate test sites and the dose immediately covered with an 8 ply, 1"x1" square gauze patch secured at the edges with nonirritation tape. Following a 60 second exposure period, the patches were removed.
Test group 1:
The test patches were removed and residual test article was wiped from the sites using dry gauze.
Test group 2:
The test patches were removed and residual test article was removed from the test sites using a 5 minute distilled water rinse (approimately 2 liters per animals). Each test site was then blotted dry with gauze.
Test group 3:
The test patches were removed and residual test article was removed from the test sites using a 1 minute 5% v/v acetic acid/distilled water rinse (approximately 0.5 liters per animal) followed by a 4 minute distilled water rinse (approximately 1.5 liters per animal). Each test site was then blotted dry with gauze.
Test group 4:
The test patches were removed and residual test article was removed from the test sites using a 30 second distilled water rinse (approximately 0.25 liters per animal), a 1 minute PEG 300 swabbing of each test site (gauze moistened in PEG 300) and a 3.5 minute distilled water rinse (approximately 1.75 liters per animal). Each test site was then blotted dry with gauze.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h - 72 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 1

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h - 48 h

Score:

2.8

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 1

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h - 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 2

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h - 48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 2

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h - 48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 3

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h - 48 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 3

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h - 48 h

Score:

3.3

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 4

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h - 48 h

Score:

3.7

Max. score:

4

Reversibility:

not fully reversible within: 14

Remarks on result:

other: Group 4

Any other information on results incl. tables

Parameter	Scoring Inerval	Group 1
	Animal No./Sex	3711/M	3710/M	3712/M
Erythema	1 hour	4^a	4^b	4^a
	24 hours	4^a,b	4^a,b	4^a,b
	72 hours	4^a,b,c	4^b	4^a,b,c
	7 days	4^b	4^b	4^b
	14 days	e	e	e
Edema	1 hour	1	1	1
	24 hurs	4	2	4
	72 hours	2	1	4
	7 days	1	0	1
	14 days	-	-	-

         a Necrosis                                                     

         b Eschar                                                        

         c Blanching                                                   

         d Desquamation                                            

         e New Dermal Tissue(post-exfoliation)  

Parameter	Scoring Inerval	Group 2
	Animal No./Sex	3749/F	3743/F	3709/M
Erythema	1 hour	4^a	4^a	4
	24 hours	4^a	4^a	4^a,b
	72 hours	4^b,c	4^a,b,c	4^b
	7 days	4^b	4^b	4^b
	14 days	d^e	d	d
Edema	1 hour	1	1	1
	24 hurs	4	2	4
	72 hours	2	4	2
	7 days	1	1	0
	14 days	-	-	-

         a Necrosis                                                     

         b Eschar                                                        

         c Blanching                                                   

         d New Dermal Tissue(post-exfoliation)                                

         eDesquamation

Parameter	Scoring Inerval	Group 3
	Animal No./Sex	3733/F	3741/F	3706/M
Erythema	1 hour	2	2	2
	24 hours	2	4^a	2
	72 hours	4^a	4^a	2
	7 days	0^b	4^c	0^b
	14 days	d	d^b	d
Edema	1 hour	2	2	2
	24 hurs	1	2	2
	72 hours	4	4	2
	7 days	1	0	0
	14 days	-	-	-

         a Blanching                                                   

         b Desquamation                            

         cEschar

         d New Dermal Tissue(post-exfoliation)

Parameter	Scoring Inerval	Group 4
	Animal No./Sex	3729/F	3731/F	3734/F
Erythema	1 hour	4^a	4^a	4^a
	24 hours	4^b	4^b	4^b
	72 hours	4^b	4^b,c	4^b
	7 days	4^b	4^b	4^b
	14 days	4^b,c	4^b,c	4^b,c
Edema	1 hour	1	1	1
	24 hurs	2	2	2
	72 hours	1	1	1
	7 days	0	0	0
	14 days	0	0	0

       a Necrosis                                                       

         b Blancing                                                     

         c Eschar                                                        

         d Desquamation                                            

         e New Dermal Tissue(post-exfoliation)