3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1972

Report date:

1972

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Principles of method if other than guideline:

BASF test: Animals were exposed for 1, 5 and 15 min and 20 h, respectively; occlusive dressing was used; animals were observed for only 8 days

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

EC Number:

230-745-9

EC Name:

3,3'-[butane-1,4-diylbis(oxy)]bispropanamine

Cas Number:

7300-34-7

Molecular formula:

C10H24N2O2

IUPAC Name:

3-[4-(3-aminopropoxy)butoxy]propan-1-amine

Specific details on test material used for the study:

- Name of test material (as cited in study report): Butandiol-di(aminopropyl)-ether
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

Vienna White

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

An application site of 2.5 cm x 2.5 cm was covered with the liquid test substance

Duration of treatment / exposure:

1, 5, 15 min and 20 h

Observation period:

8 days

Number of animals:

2 per time point

Details on study design:

After application time, the skin was washed with water

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 min exposure - next day-observation

Reversibility:

not fully reversible within: 8 days (one animal)

Remarks on result:

other: Slight erythema were observed on next day.

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 5 min exposure - 24 h post exposure

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Moderate to strong erythema was observed one hour following treatment; soft, red-brownish necrosis was visible 24 h after exposure; hard, leather-like necrosis was observed 8 days later.

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 5 min exposure - 24 h post exposure

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: Slight erythema and edema.

Results 4

Irritation parameter:

other: necrosis

Basis:

mean

Time point:

other: 15 min exposure - 24 h post-exposure

Reversibility:

not reversible

Remarks on result:

other: Lesions were not reversible until the end of the observation period (day 8), when leather-like necrosis was present in both animals.

Results 5

Irritation parameter:

other: necrosis

Basis:

mean

Time point:

other: 20 h exposure - 24 h post exposure

Reversibility:

not reversible

Remarks on result:

other: Lesions were not reversible and the formation of transverse folds was additionally visible 8 days after substance application.

Irritant / corrosive response data:

1 min exposure: slight erythema in both animals the next day; no abnormalities were detected in one animal 8 days after substance application, whereas strong scale formation was present in the other rabbit at day 8 post-exposure.
5 min exposure: moderate to strong erythema was observed in one rabbit one hour following treatment; soft, red-brownish necrosis was visible 24 h post-exposure; hard, leather-like necrosis was observed in this animal 8 days later; the other rabbit showed slight erythema and edema 24 h post-exposure; 8 days later, slight erythema was still visible and strong scale formation was present
15 min exposure: strong, leather-like, hard necrosis in one animal and soft, anemic, parchmenty necrosis in the second rabbit 24 h following substance application; these lesions were not reversible until the end of the observation period (day 8), when leather-like necrosis was present in both animals
20 h exposure: hard, leather-like, overall necrosis in both animals 24 h following substance application; lesions were not reversible and the formation of transverse folds was additionally visible 8 days after substance application.

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive) based on GHS criteria