N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From October 23,1995 to January 03, 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

GLP compliance:

yes (incl. QA statement)

Type of study:

Buehler test

Justification for non-LLNA method:

The Buehler test was conducted before the requirement for LLNA testing came into force.

Test material

Test material information

Constituent 1

Reference substance name:

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

EC Number:

219-145-8

EC Name:

N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine

Cas Number:

2372-82-9

Molecular formula:

C18H41N3

IUPAC Name:

bis(3-aminopropyl)(dodecyl)amine

Test material form:

liquid

Details on test material:

- Lot/batch No.: PN93-12
- Expiration date of the lot/batch: 21 September 1997
- Storage condition of test material: Room temperature in the dark
- Purity: 30.2%
- Physical state: A clear colourless liquid

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: D. Hall, Newchurch, Staffordshire, England.
- Age at study initiation: Approx. 6-7 weeks
- Weight at study initiation: 270 to 315 g
- Housing: In groups of five in suspended metal cages with wire mesh floors
- Diet: A vitamin C enriched guinea-pig diet FD2, ad libitum.
- Water (e.g. ad libitum): Hay was given weekly.
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Approx. 21
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

a) for induction: 1% v/v (0.33% test substance) in distilled water
b) for challenge: 0.5% v/v (0.15% test substance) in distilled water

Challenge

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

a) for induction: 1% v/v (0.33% test substance) in distilled water
b) for challenge: 0.5% v/v (0.15% test substance) in distilled water

No. of animals per dose:

20 per group

Details on study design:

RANGE FINDING TESTS: The topical irritancy of a range of dilutions of the test substance was investigated. Based on the results of this study, 1% v/v concentration was chosen for induction and 0.5% v/v concentration was chosen for challenge. The former concentration was the concentration that produced some irritation but did not give rise to adverse effects, while the latter was the maximum concentration not giving rise to irritating effects.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 20 test animals
- Control group: 10 negative control animals
- Site: Left shoulder region, 20 x 20 mm
- Frequency of applications: Days 1, 8 and 15
- Duration: 2 weeks
- Concentrations: 1% v/v

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 2 weeks after final induction
- Exposure period: 6 h
- Test groups: 20 test animals
- Control group: 10 negative control animals
- Site: Right flank, 50 x 50 mm
- Concentrations: 0.5% v/v
- Evaluation (hr after challenge): 24 and 48 h after the removal of the patches

Results and discussion

In vivo (non-LLNA)

Results

Results 1

Key result

Reading:

1st reading

Hours after challenge:

24

Group:

test chemical

Dose level:

0.15%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Erythema, edema and dryness and sloughing of the epidermis

Remarks on result:

other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.15%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Erythema, edema and dryness and sloughing of the epidermis.

Results 2

Key result

Reading:

2nd reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.15%

No. with + reactions:

0

Total no. in group:

20

Clinical observations:

Erythema, edema and dryness and sloughing of the epidermis

Remarks on result:

other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.15%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: Erythema, edema and dryness and sloughing of the epidermis.

Results 3

Key result

Reading:

other: Both readings: 24 and 48 h

Hours after challenge:

48

Group:

negative control

Dose level:

0%

No. with + reactions:

1

Total no. in group:

10

Clinical observations:

Erythema, edema and dryness and sloughing of the epidermis

Remarks on result:

other: see Remark

Remarks:

Reading: other: Both readings: 24 and 48 h. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: Erythema, edema and dryness and sloughing of the epidermis.

Results 4

Reading:

other: Overall result

Group:

positive control

Dose level:

25%

Remarks on result:

positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the study conditions, the test substance was not considered to be sensitising to the skin of guinea-pigs.