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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: Acceptable publication which meets basic scientific principles

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
testing on 6 animals
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2-(3-aminopropoxy)ethoxy]ethanol
EC Number:
203-960-0
EC Name:
2-[2-(3-aminopropoxy)ethoxy]ethanol
Cas Number:
112-33-4
Molecular formula:
C7H17NO3
IUPAC Name:
2-[2-(3-aminopropoxy)ethoxy]ethanol
Details on test material:
- Name of test material (as cited in study report): Polyglycolamine H-163
- Physical state: transparent, colorless, low viscosity liquid
- Analytical purity: not given
- Lot/batch No.: 496500

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
occlusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated sites of the same animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
3 minutes and 1 hour
Observation period:
14 days
reading time points:
3 minute exposure - 1, 24, 48, 72 hours and 7, 10 and 14 days
1 hour exposure - 2, 24, 48, 72 hours and 7, 10 and 14 days
Number of animals:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data, probably after 3 minutes and 1 hour

SCORING SYSTEM:
Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Remarks on result:
other: 1 hour exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.8
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 1 hour exposure
Irritation parameter:
other: necrosis
Basis:
mean
Remarks:
over all 6 animals
Time point:
other: starting from 24 hours
Reversibility:
not reversible
Remarks on result:
other: 1 hour exposure; All 6 animals developed necrosis as early as 1 day post treatment and at the latest 7 days post treament. Necrosis was not reversible except one animal showed desquamation after 10 and 14 days instead of necrosis.
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: 3 minutes exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
over all 6 animals
Time point:
other: mean over 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Remarks on result:
other: 3 minutes exposure
Irritant / corrosive response data:
A one-hour application of 0.5 mL of Polyglycolamine H-163 to occluded rabbit skin resulted in minor erythema and minor to moderate edema on 6 of 6 rabbits tested. Ecchimosis was apparent on 3 animals at one hour (after the end of the contact period) or at 3 days. Within one to 7 days, superficial necrosis developed on all 6 rabbits with full-thickness necrosis apparent on one at 10 days. There was no edema or erythema remaining on any animal by 7 or 10 days, respectively. Desquamation was observed on 5 rabbits within 7 to 14 days. Fissuring was also apparent on 3 rabbits by 10 days. At 14 days, 2 rabbits developed ulceration and 3 had alopecia. Other irritation that persisted at this time included necrosis, fissuring and desquamation.
Following a 3-minute contact period with 0.5 mL of sample (covered skin), minor erythema was evident on 5 of 6 animals. There was no edema observed on any rabbit. By 7 days, the erythema subsided on all rabbits. At this time, desquamation was apparent on one animal and a small raised, crust-like area (scab) was observed on another. The remaining 4 rabbits had a normal appearance. At 14 days, alopecia also appeared on the 2 affected animals. No other irritation, except for desquamation on one of the affected animals, was apparent at this time.

Any other information on results incl. tables

table1: Results of skin irritation study (1 hour exposure)

Observation time

Rabbit No.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

2 hours

1

1

1

1

1

2

1

1

1

1

1

1

24 hours

1

1

1

1

1

1

1

1

1

2

1

1

48 hours

1

1

1

1

1

1

1

0

1

2

1

0

72 hours

1

0

1

1

1

0

1

0

1

1

1

0

mean value 24+48+72 hours

1

0.7

1

1

1

0.7

1

0.3

1

1.7

1

0.3

mean value 24+48+72 hours

all animals

1

0.8

 

 

 

 

 

 

 

 

 

 

table2: Results of skin irritation study (3 minutes exposure)

Observation time

Rabbit No.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 hours

1

0

1

0

1

0

1

0

1

0

0

0

24 hours

0

0

0

0

1

0

1

0

1

0

0

0

48 hours

0

0

0

0

0

0

0

0

1

0

0

0

72 hours

0

0

0

0

0

0

0

0

1

0

0

0

mean value 24+48+72 hours

0

0

0

0

0.3

0

0.3

0

1

0

0

0

mean value 24+48+72 hours

all animals

0.3

0

 

 

 

 

 

 

 

 

 

 

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information