Registration Dossier
Registration Dossier
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EC number: 203-236-4 | CAS number: 104-78-9
Skin sensitisation
Administrative data
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test 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.
Test material
- Reference substance name:
- 3-aminopropyldiethylamine
- EC Number:
- 203-236-4
- EC Name:
- 3-aminopropyldiethylamine
- Cas Number:
- 104-78-9
- Molecular formula:
- C7H18N2
- IUPAC Name:
- (3-aminopropyl)diethylamine
- Details on test material:
- - Name of test material (as cited in study report): diethylaminopropylamine
- Physical state: liquid
- Analytical purity: 99.83%
- Purity test date: no data
- Lot/batch No.: 8804193
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: origin: ATOCHEM, La Chambre
Constituent 1
In vivo test system
Test animals
- 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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- Intracutaneous induction: 0.1%
Occlusive epicutaneous induction: 10%
Occlusive epicutaneous challenge: 1%
Challengeopen allclose all
- 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
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- 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.
Applicant's summary and conclusion
- 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
According to the maximization method of Magnusson and Kligman, 3 -aminopropyldiethylamine did not induce any sensitization process in the guinea-pig.
was observed.
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