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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
Reference substance name:
Dipropylamine
EC Number:
205-565-9
EC Name:
Dipropylamine
Cas Number:
142-84-7
Molecular formula:
C6H15N
IUPAC Name:
N-propylpropan-1-amine
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

Resultsopen allclose all
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
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
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
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
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
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
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
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

4a

4b

4a

24 hours

4a,b

4a,b

4a,b

72 hours

4a,b,c

4b

4a,b,c

7 days

4b

4b

4b

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

4a

4a

4

24 hours

4a

4a

4a,b

72 hours

4b,c

4a,b,c

4b

7 days

4b

4b

4b

14 days

de

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

4a

2

72 hours

4a

4a

2

7 days

0b

4c

0b

14 days

d

db

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

4a

4a

4a

24 hours

4b

4b

4b

72 hours

4b

4b,c

4b

7 days

4b

4b

4b

14 days

4b,c

4b,c

4b,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)

Applicant's summary and conclusion

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