N-(2-aminoethyl)-1,3-propanediamine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2007-10-26 - 2008-02-07

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed under GLP regulations. For read across justification please refer to IUCLID chapter 13.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Justification for non-LLNA method:

An appropriate guinea pig maximisation test is available

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis(3-aminopropyl)ethylenediamine

EC Number:

234-147-9

EC Name:

N,N'-bis(3-aminopropyl)ethylenediamine

Cas Number:

10563-26-5

Molecular formula:

C8H22N4

IUPAC Name:

N1,N1'-1,2-ethanediylbis(1,3-propanediamine)

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Strain: Dunkin Hartley, Crl:HA
- Source: Charles River Laboratories, Kisslegg - Germany
- Age at study initiation: 5 – 8 weeks
- Weight at study initiation: 377 g – 440 g
- Housing: The animals were housed in fully air-conditioned rooms (5 animals per cage)
- Cage type: Plastic cages with perforated base; floor area: 4000 cm² (Tecniplast Deutschland GmbH)
- Diet: Kliba Labordiaet (Provimi Kliba SA, Kaiseraugst, Basel, Switzerland), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 14 days before the first test-substance application.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: Doubly distilled water

Induction 2

Concentration / amount:

All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: Doubly distilled water

Challenge 2

Concentration / amount:

All inductions were performed with a 10% test-substance preparation in doubly distilled water and for the challenge a 5% test-substance preparation in doubly distilled water was chosen.

No. of animals per dose:

Number of animals of the control group: 10
Number of animals of the test group: 20

Details on study design:

Pretest:
In a pretest, the irritancy profile was determined by applying 0.5 ml of various concentrations (1%, 5%, 10%, and 25%) of aqueous test substance solutions to a 2-cm² area of the shaved flanks of Guinea pigs under occlusive conditions. Test sites were visually evaluated 1 h, 24 h and 48 h after application of test solutions. In accordance with the OECD Guideline 406 a slightly irritating concentration should be used in the main test for induction whereas the maximum non-irritant concentration should be applied for challenge.

Induction:
During the induction phase of the main test, 0.5 ml of test solution were applied to an 2-cm² area of the skin of the flank of groups of 5 Guinea pigs three times at weekly intervals, on days 0, 7 and 14 on the same application site. Skin readings were performed 24 h after application. The control animals were not treated since the doubly distilled water used as formulating agent was not expected to influence the result of the study.

Challenge:
Fourteen days after the last induction treatment, each test group animal and animals from control group were challenged with 0.5 ml of 5% aqueous solution of the test substance to a 2-cm² area on the previously untreated flank. Skin reactions were read at 24 and 48 after application of the solutions.

Evaluation:
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch was taken into account for the determination of the sensitization rate. The evaluation "sensitizing" results if at least 15 per cent of the test animals exhibit skin reactions.

Positive control substance(s):

no

Remarks:

A positive control with a known sensitizer was not included in this study. However, a separate study was performed twice a year in the same laboratory.

Results and discussion

Positive control results:

The positive controls with Alpha-Hexylcinnamaldehyde, techn. 85% showed that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.

In vivo (non-LLNA)

Results

Results 1

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

5% test-substance preparation in doubly distilled water

No. with + reactions:

12

Total no. in group:

20

Clinical observations:

4/20: Discrete or patchy erythema (grade 1); 8/20: Moderate and confluent erythema (grade 2)

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 12.0. Total no. in groups: 20.0. Clinical observations: 4/20: Discrete or patchy erythema (grade 1); 8/20: Moderate and confluent erythema (grade 2).

Results 2

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5% test-substance preparation in doubly distilled water

No. with + reactions:

6

Total no. in group:

20

Clinical observations:

6/20: grade 1; 10/20: grade 2

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5% test-substance preparation in doubly distilled water. No with. + reactions: 6.0. Total no. in groups: 20.0. Clinical observations: 6/20: grade 1; 10/20: grade 2 .

Results 3

Reading:

1st reading

Hours after challenge:

24

Group:

negative control

Dose level:

5% test substance preparation in doubly distilled water

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5% test substance preparation in doubly distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.

Results 4

Reading:

2nd reading

Hours after challenge:

48

Group:

negative control

Dose level:

5% test substance preparation in doubly distilled water

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

none

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5% test substance preparation in doubly distilled water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.