Tridecanamine, N-tridecyl-, branched and linear

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:

1970

Report date:

1970

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:

Method: BASF-Test: Animals were treated for 1, 5, 15 min and 20 hours using occlusive conditions. An application site of 2.5x2.5 cm was covered with the liquid test substance. After the application time (1, 5 and 15 min) the skin was washed with Lutrol (50%). The animals were observed for 8 days and skin changes were recorded daily. The report describes findings after 24 hours and at the end of the observation period (8 days). For a final evaluation, the findings after 48 h and 72 h from the raw data were taken into account.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Tridecanamine, N-tridecyl-, branched and linear

EC Number:

309-798-8

EC Name:

Tridecanamine, N-tridecyl-, branched and linear

Cas Number:

101012-97-9

Molecular formula:

C24 H50 NH - C28 H58 NH

IUPAC Name:

(2-methyldodecyl)(tridecyl)amine; ditridecylamine

Details on test material:

- Name of test material (as cited in study report): Ditridecylamin techn.
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 2.48 kg; male 2.53 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

no

Duration of treatment / exposure:

1, 5, 15 min and 20 h

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

1, 5, and 15 min exposure

Basis:

mean

Time point:

other: 24 h

Score:

4

Max. score:

4

Reversibility:

not reversible

Results 2

Irritation parameter:

erythema score

Remarks:

1, 5, and 15 min exposure

Basis:

mean

Time point:

other: 8 d

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: severe scaling, parchment skin

Results 3

Irritation parameter:

erythema score

Remarks:

20 h exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

3 - 4

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: marked necrosis and severe redness extending far beyond the area of exposure

Results 4

Irritation parameter:

edema score

Remarks:

1, 5, and 15 min exposure

Basis:

mean

Time point:

other: 24 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Results 5

Irritation parameter:

edema score

Remarks:

1, 5, and 15 min exposure

Basis:

mean

Time point:

other: 8 d

Score:

3

Max. score:

4

Reversibility:

not reversible

Results 6

Irritation parameter:

edema score

Remarks:

20 h exposure

Basis:

mean

Time point:

other: 24 h - 8 d

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: extending far beyond the area of exposure

Irritant / corrosive response data:

After 8 days the skin has a parchment-like necrosis that extends far beyond the area of exposure, the surroundings show severe erythema and edema when exposed to a maximum of 15min.
Exposure for 20h leads to severe necrosis.

Applicant's summary and conclusion

Interpretation of results:

highly corrosive

Remarks:

Migrated information