Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin

In vivo

Rabbit, 1 h: corrosive (full thickness necrosis in 2/2 animals; Draize-test; BASF 1979)

Rabbit, 15 min, occlusive: slightly irritating (desquamation in 1/2 animals; BASF 1958)

Rabbit, 20 h, occlusive: corrosive (full thickness necrosis in 2/2 animals; BASF 1967)

 

Eye

In vivo

Rabbit: serious risk of eye damage in 4/4 animals (Draize-test; BASF 1958)

Rabbit: serious risk of eye damage in 2/2 animals (Draize-test; BASF 1967)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
no guideline followed
Principles of method if other than guideline:
Draize test
GLP compliance:
not specified
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
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
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

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.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance in the amount indicated was applied to the conjunctival sac of rabbits. The non-treated adjacent eye served as control. The animals were observed several times on the treatment day and 8 days afterwards, and findings were recorded on working days. The eyes were not washed out after 24 hours after substance application. Findings were graded as described in OECD test guideline 405.
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data
Vehicle:
unchanged (no vehicle)
Controls:
other: concurrent NaCl
Amount / concentration applied:
one drop (ca. 0.05 mL)
Duration of treatment / exposure:
single application
Observation period (in vivo):
24 days
Number of animals or in vitro replicates:
4
Details on study design:
SCORING SYSTEM: no scores used in the raw data
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24 h
Reversibility:
not reversible
Remarks on result:
other: no scores used in raw data
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
One drop of the undiluted test substance applied to the conjunctival sac of the eye produced very strong reddening within 10 min combined with enhanced secretion, corneal opacity, and slight chemical burning of the mucosa. The signs of mucosal irritation/corrosion were visible for at least 3 days. On day 3 ciliar injections and mucosal bleedings were observed combined with smeary secretion, slight chemosis and diffuse corneal opacity. After 6 days clear signs of irreversible corneal damage and iritis were observable including scar formation and cloudy corneal opacity. At day 8 slight reddening, slight mucosal bleedings, smeary secretion and cloudy corneal opacity were still visible.
At the end of the study period (day 24) irreversible signs of corneal damage were observed as well as ciliar injections in the lower half of the eyeball in two animals. Two animals were euthanized on day 6 of the study due to massive chemical burnings of the eye including black-brown necroses, strong bleedings/bloody secretions and foggy corneal opacity.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
3-Aminopropan-1-ol causes severe eye damage.
At the end of the study period (day 24) irreversible signs of corneal damage were observed as well as ciliar injections in the lower half of the eyeball in two animals. Two animals were euthanized on day 6 of the study due to massive chemical burnings of the eye including black-brown necroses, strong bleedings/bloody secretions and foggy corneal opacity.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

There are valid in vivo data available for the assessment of the skin and eye irritation potential of 3-aminopropan-1-ol.

 

Skin

A Draize test was performed with two White Vienna rabbits (BASF AG, 1979). A 1-hour exposure to 0.5 g of the unchanged test substance produced non-reversible severe erythema and edema (overall erythema score of 4 and edema score of 2.25 for the readings 24 and 48 h) and full thickness necrosis in both animals persisting at the final reading on day 8. A 3 min exposure led to strong erythema persisting till the end of the study period in 1/2 animals.

 

In a second report, two rabbits were exposed to the unchanged test substance for 1, 5 and 15 min under occlusive conditions (BASF AG, 1958). Slight erythema were reversible at least within 11 days, edema were not observed, while scaling was reported in one animal from day 4 on.

 

In a third report, 2 animals were exposed to the unchanged test substance for 1, 5, 15 min and for 20 hours under occlusive conditions (BASF AG, 1967). The test substance produced moderate to severe erythema but no edema after an exposure for 1 min under occlusive conditions. When the rabbits were exposed to 5 or 15 min under occlusive conditions also strong irritation was visible with strong erythema and no (5 min) to slight edema (15 min) in one animal. Overall erythema score was 2.0 and 2.5 respectively. After 5 min exposure soft necrosis occurred in 1/2 animals while the other animal showed desquamation from day 7 on. After 15 min of exposure necrosis were observed in both animals, one of them showing full thickness necrosis. Application of the test substance for one min under occlusive conditions resulted in moderate to strong erythema visible for at least 72 hours. In one animal strong desquamation was visible on day 7 after application.

 

Two other publications by Smith et al. (1962) and the American Cyanamide Co. (1954) judge 3-aminopropan-1-ol as corrosive to the skin of rabbits without showing details on the tests performed.

  

Eye

An in vivo test comparable to the Draize test was performed with four rabbits (BASF AG 1958). Eyes were left unwashed after application of ca. 0.1 mL 3-aminopropan-1-ol and were observed for 24 days. The test substance caused very strong reddening within 10 min combined with enhanced secretion, corneal opacity, and slight chemical burning of the mucosa. At the end of the study period (day 24) irreversible signs of corneal damage were observed as well as ciliar injections in the lower half of the eyeball in all animals. Two animals were euthanized on day 6 of the study due to massive chemical burnings of the eye including black-brown necroses, strong bleedings/bloody secretions and foggy corneal opacity.

 

The results of another Draize test (BASF AG, 1967) also induced severe chemical burns in rabbits within 10 min after substance application. After 8 days, at the end of the observation period, a severe ulceration and scar formation at the side of the eye lid was observed in one animal, as well as strong pus formation. In the second animal adhesions of the eye lids could be observed.

 

Two other publications by Smith et al. (1962) and the American Cyanamide Co. (1954) judged 3-aminopropan-1-ol as corrosive to the eyes of rabbits when applied undiluted, a 10 % dilution caused strong but reversible irritation and a 1% dilution caused only mild to moderate transient irritation. Details on the tests performed by the American Cynamide Corp. are not available.

 

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. The substance is considered to be classified as skin corrosive Category 1B (H314: “Cause severe skin burns and eye damage”) and has to be classified for serious eye damage Cat.1 (H318: “ Causes serious eye damage”) according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.