2-[2-(3-aminopropoxy)ethoxy]ethanol

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: 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

Test material information

Constituent 1

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]ethan-1-ol

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

Results

Results 1

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

Results 2

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

Results 3

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.

Results 4

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

Results 5

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