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EC number: 234-148-4 | CAS number: 10563-29-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 1993-09-09 to 1994-01-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, OCDE guideline 406 (1981 May the 12th)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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
Test material
- Reference substance name:
- N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine
- EC Number:
- 234-148-4
- EC Name:
- N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine
- Cas Number:
- 10563-29-8
- Molecular formula:
- C8H21N3
- IUPAC Name:
- {3-[(3-aminopropyl)amino]propyl}dimethylamine
- Details on test material:
- - Name of test material (as cited in study report): Dimethyldipropylenetriamine (DMAPAPA)
- Physical state: liquid
- Analytical purity: 99.10% (w/w)
- Purity test date: 1993-02-01
- Lot/batch No.: P0911
- Expiration date of the lot/batch: no data
- Storage condition of test material: at room temperature and protected from light
- Other: analysis number 9301 P0355
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: Centre d'élevage Lebeau, 78950 Gambais, France
- Age at study initiation: no data
- Weight at study initiation: 399+/-28g (Males), 391+/-39g (Females)
- Housing: individually
- Diet (e.g. ad libitum): ad libitum "Guinea pig sustenance reference 106 diet" (U.A.R., 91360 Villmoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a F.G. Milliporemembrane 0,22µ)
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 50+/-20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 1993-10-08
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction phase: 1%
cutaneous induction phase: 25%
challenge phase: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction phase: 1%
cutaneous induction phase: 25%
challenge phase: 10%
- No. of animals per dose:
- control group: 10 animals (5 Males + 5 Females)
treated group: 20 animals (10 Males + 10 Females) - Details on study design:
- RANGE FINDING TESTS:
Determination of the Minimum Irritant Concentration by intradermal route at increasing concentrations (1%, 10%, 25%). Result: MIC=1%
Determination of the Minimum Irritant Concentration (MIC) and the Maximal Non Irritant Concentration (MNIC) by cutaneous route at increasing concentrations (5%, 10%, 25%, 50%, 75%, 100%). Result: MIC= 25%, MNIC=10%.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction D1
3injections on the scapular area:
. 0.1mL of Freund's complete adjuvant 50% in 0.9% NaCl
. 0.1mL of the test item 0.1% in water (treated group) or vehicle (control group)
. 0.1mL of a mixture 50/50 (V/V) of Freund complete adjuvant 50% in 0.9% NaCl and vehicle (for control group) or test item 1% in vehicle (for treated group)
Cutaneous induction D8
. On day 7, the irritation created with the application of sodium Laurylsulfate 10% in vaseline.
. On day 8, occlusive application on the scapular area of 0.5mL of the test item 25% (for treated group) or vehicle (for control group) for 48hours.
B. CHALLENGE EXPOSURE D22
On day 22, 24-hour occlusive application on the scapular area of 0.5mL of the test item 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. - Positive control substance(s):
- yes
- Remarks:
- Dinitro 2,4 Chlorobenzene: Positive result in recent study (July 1993- CIT/Study No. 10829 TPG) on 5 females. Induction: test substance injected intradermally 0.05% (d1) and applied cutaneously 0.5% (d8) concentration. Challenge: 0,1% r flank 0.5% l flank
Study design: in vivo (LLNA)
- Positive control substance(s):
- other: Dinitro 2,4 chlorobenzene
- Statistics:
- no
Results and discussion
- Positive control results:
- Positive skin sensitization reactions in 5/5 female Guinea pigs (July 1993- CIT/Study No. 10829 TPG).
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema/oedema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No erythema/oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No erythema/oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No erythema/oedema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 6
- Total no. in group:
- 19
- Clinical observations:
- well defined erythema/no oedema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 6.0. Total no. in groups: 19.0. Clinical observations: well defined erythema/no oedema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 3
- Total no. in group:
- 19
- Clinical observations:
- well defined erythema/no oedema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 3.0. Total no. in groups: 19.0. Clinical observations: well defined erythema/no oedema.
Any other information on results incl. tables
Group |
Sex |
Animal |
24h |
48h |
||||||
Erythema |
Oedema |
Erythema |
Oedema |
|||||||
RF |
LF |
RF |
LF |
RF |
LF |
RF |
LF |
|||
Control |
M |
21 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
22 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
23 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
25 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Control |
F |
36 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
37 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
38 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
39 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
40 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Treated |
M |
26 |
0 |
2 |
0 |
0 |
0 |
2/S |
0 |
0 |
27 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
28 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
29 |
0 |
2 |
0 |
0 |
0 |
2/S |
0 |
0 |
||
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
31 |
0 |
2 |
0 |
0 |
0 |
1/S |
0 |
0 |
||
32 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
34 |
0 |
1 |
0 |
0 |
0 |
1/S |
0 |
0 |
||
35 |
0 |
1 |
0 |
0 |
0 |
1/S |
0 |
0 |
||
|
||||||||||
Treated |
F |
41 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
42 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
43 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
44 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
||
45 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
46 |
- |
- |
- |
- |
- |
- |
- |
- |
||
47 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
||
48 |
0 |
2 |
0 |
0 |
0 |
1/S |
0 |
0 |
||
49 |
0 |
2 |
0 |
0 |
0 |
1/S |
0 |
0 |
||
50 |
0 |
3 |
0 |
0 |
0 |
3/S |
0 |
0 |
||
S=Skin dryness
Applicant's summary and conclusion
- Interpretation of results:
- other: Sensitiser cat. 1B
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- DIMETHYLDIPROPYLENETRIAMINE induced positive skin sensitization cutaneous reactions in 6/19 (32%) guinea pigs. The allergenicity level of the test substance was moderate (III) in guinea-pigs.
- Executive summary:
The delayed contact hypersensivity of dimethyldipropylenetriamine (DMAPAPA) was evaluated in Guinea pigs according to OECD N°406 guideline (Magnusson and Kligman test). The induction phase has been realized both by intradermal route on day 1 (DMAPAPA 1% in vehicle) and by cutaneous route on day 8 (DMAPAPA 25%) 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 22 by cutaneous application of DMAPAPA 10%; the cutaneous reactions were scored 24 and 48 hours after the challenge phase. Only one female of the treated group died on day 9 but this death was not considered to be treatment-related. No cutaneous reaction was observed in the animals of the control group. In the treated group, inconclusive evidence of sensitisation skin reactions (very slight erythema: score of 1) were noted in 6/19 animals after 24 hours. Positive response characterised by a well defined and moderate erythema (scores of 2 and 3) were noted in 6/19 animals after 24 hours. In addition, a dryness of the skin was noted after 48 hours in 8/19 animals.
No oedema was noted. In conclusion, the allergenicity level of Dimethyldipropylenetriamine was moderate (III) in guinea pigs.
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