1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1979-03-21 to 1979-03-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: 49 CFR 172.240

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol

EC Number:

264-261-4

EC Name:

1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol

Cas Number:

63469-23-8

Molecular formula:

C11H26N2O2

IUPAC Name:

1-{[3-(dimethylamino)propyl](2-hydroxypropyl)amino}propan-2-ol

Test material form:

liquid

Details on test material:

Details described in study specific records

Specific details on test material used for the study:

- Name of test material (as cited in study report): none used
- Sample label: 4236-21-35
- Substance type: Clear liquid
- Physical state: Liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Perfection Breeders, Box 75, Douglasville, Pa.
- Weight at study initiation: 2 - 3 kg
- Housing: The animals were housed 2/cage (30" x 18" x 18") in a room reserved exclusively for rabbits on acute tests. The cages were identified by test material, starting date, animal number and sex. In addition, odd numbered animals in each cage were identified with an indelible ear mark.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/test site

Duration of treatment / exposure:

4 hours

Observation period:

Dermal reactions were scored at 4 and 48 hours. Signs of systemic effects were recorded at dermal observation time.

Number of animals:

6 (4 males and 2 females)

Details on study design:

TEST SITE
0.5 mL of the test material as received was applied once dermally to one site per animal under 2.5 cm square gauze patches. The trunk of the rabbits was wrapped with impervious material.

REMOVAL OF TEST SUBSTANCE
The test material was kept in contact with the skin for 4 hours, at which time the wrappings were removed

SCORING SYSTEM:
Corrosivity, defined as destruction or irreversible alteration of the tissue, is considered to have occurred if at any of the readings there is ulceration or necrosis. Tissue destruction does not include merely sloughing of the epidermis, or erythema, edema or fissuring.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4h - 48h

Score:

1 - 3

Max. score:

4

Reversibility:

no data

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4h - 48h

Score:

0 - 2

Max. score:

4

Reversibility:

no data

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: other time points used (4h-48h)

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: other time points used (4h-48h)

Irritant / corrosive response data:

Slight to moderate erythema and no or slight edema was noted in all animals at 4 hours or 48 hours.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

The substance was observed to be non-corrosive.