1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984-02-27 to 1984-02-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Well documented study performed according to a method similar to OECD Guideline 404 with a minor deviation: occlusive dressing used instead of semi-occlusive

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Occlusive dressing used instead of semi-occlusive

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol

EC Number:

266-587-2

EC Name:

1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol

Cas Number:

67151-63-7

Molecular formula:

C13H31N3O

IUPAC Name:

1-Bis(3-(dimethylamino)propylamino)-2-propanol

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 5601-23-1
- 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: Sgarlat's Rabbitry, Harvey's Lake, Pennsylvania
- Weight at study initiation: 2 - 3 kilograms
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

Animals were observed at 4 and 48 hours after application of the test material.

Number of animals:

Iniatially, two rabbits will be administered the test article. The test will be considered positive if both animals exhibit a positive response and the study will be terminated. If only one animal or no animals exhibit a positive response, the test will be repeated with a different group of two rabbits. If one animal exhibits a positive response in the second group, the test article will be considered corrosive and the study will be terminated provided there was no positive response in group I. If no positive reactions are observed in group II, an additional group of two rabbits will be added and conclusions will be based on a total of six rabbits.

Details on study design:

SCORING SYSTEM:
Corrosion will be considered to have resulted if the substance in contact with the rabbit skin has caused destruction or irreversible alteration of the tissue on at least two out of each six rabbits tested. Tissue destruction 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:

other: Skin necrosis

Basis:

animal #1

Time point:

other: 4h

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

other: Skin necrosis

Basis:

animal #2

Time point:

other: 4h

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

other: Skin necrosis

Basis:

animal #1

Time point:

48 h

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 4

Irritation parameter:

other: Skin necrosis

Basis:

animal #2

Time point:

48 h

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

positive indication of irritation

Remarks:

Skin corrosion (tissue destruction) was considered to have occurred if ulceration or necrosis was observed in any of the readings

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Skin necrosis was visible in both rabbits at 4 and 48 hours after application of the test article.

Other effects:

Skin corrosion (tissue destruction) was considered to have occurred if ulceration or necrosis was observed in any of the readings

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Based upon the results of the DOT Corrosivity Study in Rabbits, the test substance was considered to be corrosive.