Registration Dossier

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Draize test
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
3-aminopropan-1-ol
EC Number:
205-864-4
EC Name:
3-aminopropan-1-ol
Cas Number:
156-87-6
Molecular formula:
C3H9NO
IUPAC Name:
3-aminopropan-1-ol

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 3.1 kg

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin
Amount / concentration applied:
no data
Duration of treatment / exposure:
3 min and 1 hour
Observation period:
8 days
Number of animals:
2 animals (1 male, 1 female)
Details on study design:
no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 8 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 8 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 8 d
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 8 d
Score:
2
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48 h
Score:
2.25
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure

Any other information on results incl. tables

After 8 days, the erythema and edema score of both animals were 4 and 2 respectively, necrosis was observed in both animals.

A parasitic infestation of the liver was observed in both animals, which was of no relevance for this study.

 Individual readings:

Readings

Animal

Exposure period: 3 min

Erythema

Edema

Additional findings

3 min

1

2

0

 

2

2

0

spotted appearance

24 h

1

2

1

 

2

2

1

spotted appearance

48 h

1

2

0

 

2

2

1

 

72 h

1

nd

nd

 

2

nd

nd

 

8 d

1

0

0

 

2

1

0

desquamation

Mean 24, 48, 72 h

1

2

0.5

 

2

2

1

 

Mean 24, 48, 72 h

1-2

2

0.75

 

 

Readings

Animal

Exposure period: 1 hour

Erythema

Edema

Additional findings

1 h

1

2

2

spotted appearance, exceeding area of application

2

2

2

spotted appearance, exceeding area of application, soft necrosis

24 h

1

4

2

exceeding area of application, soft necrosis

2

4

2

exceeding area of application, soft necrosis

48 h

1

4

3

exceeding area of application, parchment-like necrosis

2

4

2

exceeding area of application, parchment-like necrosis

72 h

1

nd

nd

 

2

nd

nd

 

8 d

1

4

2

exceeding area of application, leather-like necrosis

2

4

2

leather-like necrosis

Mean 24, 48 h

1

4

2.5

 

2

4

2

 

Mean 24, 48 h

1-2

4

2.25

 

nd: not determined

Leather-like or hard necroses represent so-called full-thickness necroses involving all layers of the skin. Such necroses are relevant for classification representing a chemical being corrosive to the skin.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
Necrosis was observed in both animals after an exposure period of 1 hour.