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Diss Factsheets

Administrative data

Description of key information

According to the maximization method of Magnusson and Kligman, 3 -aminopropyldiethylamine did not induce any sensitization process in the guinea-pig.

 

The delayed contact hypersensivity of 3 -aminopropyldiethylamine (DEAPA) was evaluated in Guinea pigs according to OECD guideline 406 (Magnusson and Kligman test) (Clouzeau, 1988). The induction phase has been realized both by intradermal route on day 1 (DEAPA 0.1% in vehicle) and by cutaneous route on day 9 (DEAPA 10%) in 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 29 by cutaneous application of DEAPA 1%; the cutaneous reactions were scored 24 and 48 hours after the challenge phase. No clinical sign, no death were noted during the study. Twenty-four and 48 hours after the removal of the dressing, no cutaneous reaction was observed.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, OECD 406 Guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study performed before the implementation of the REACH regulation.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Shamrock Bio Service (78150 Gambais, France)
- Age at study initiation: no data
- Weight at D-4: 329+/-11g (males), 300+/-18g (females)
- Housing: individually in polycarbonate cages (48 x 27 x 20xm)
- Diet (e.g. ad libitum): ad libitum guinea pig maintenance pellet ref 106 (U.A.R., 91360 Villemoisson, sur Orge, France)
- Water (e.g. ad libitum): ad libitum tap water filtered on a 0.22µm membrane (Société Millipore, 78140 Velizy, France)
- Acclimation period: >7days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To:no data
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Intracutaneous induction: 0.1%
Occlusive epicutaneous induction: 10%
Occlusive epicutaneous challenge: 1%
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Intracutaneous induction: 0.1%
Occlusive epicutaneous induction: 10%
Occlusive epicutaneous challenge: 1%
No. of animals per dose:
5 males and 5 females for control group
10 males and 10 females for treated group
Details on study design:
RANGE FINDING STUDY
Intradermal administration: 0.1, 5, 10, 25%
Cutaneous administration: 1, 10, 25, 50%

MAIN STUDY
A. INDUCTION EXPOSURE
* Intradermal induction:
- On day 1, 3injections are realized on the scapular area:
- 0.1mL of Freund's complete adjuvant at 50% in 0.9%NaCl,
- 0.1mL of the test item at 0.1% (for treated group) or 0.1mL of vehicle (for control group),
- 0.1mL of a mixture 50/50 (V/V) of Freund's complete adjuvant in 0.9% NaCl and the test item at 0.1% (for treated group) or the vehicle (for control group).

* Cutaneous induction:
- On day 9, occlusive application on the scapular area of 0.5mL of the test item 10% (for treated group) or vehicle (for control group) for 48hours.

B. CHALLENGE EXPOSURE D26
On day 26, 24hours occlusive application on the scapular area of 0.5mL of DEAPA 10% on the right flank and 0.5mL of the vehicle on the left flank.
Reactions are evaluated 24 and 48 hours after removal of the dressing.
Challenge controls:
no
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
not sensitising
Conclusions:
According to the maximization method of Magnusson and Kligman, DIETHYLAMINOPROPYLAMINE (DEAPA) did not induce any sensitization process in the guinea-pig.
Executive summary:

The delayed contact hypersensivity of 3 -aminopropyldiethylamine (DEAPA) was evaluated in Guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test) and in compliance with Good Laboratory Practices.

The induction phase has been realized both by intradermal route on day 1 (DEAPA 0.1% in vehicle) and by cutaneous route on day 9 (DEAPA 10%) in 2 groups of guinea pigs: 5 males and 5 females for control group and 10 males and 10 females for treated group. The challenge phase was realized on day 29 by cutaneous application of DEAPA 1%; the cutaneous reactions were scored 24 and 48 hours after the challenge phase.

No clinical sign, no death were noted during the study. Twenty-four and 48 hours after the removal of the dressing, no cutaneous reaction
was observed.

According to the maximization method of Magnusson and Kligman, 3 -aminopropyldiethylamine did not induce any sensitization process in the guinea-pig.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the harmonised classification and labelling(CLP) approved by the European Union:

- Skin Sens. 1, H317

Self classification according to CLP criteria

No classification is warranted for skin sensitization.