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Registration Dossier
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EC number: 209-940-8 | CAS number: 598-56-1
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- no data on the use of a positive control substance
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The LLNA test was not perfomed as the guideline study was adopted in 2010 after the GPMT study was performed in 1989.
Test material
- Reference substance name:
- Ethyldimethylamine
- EC Number:
- 209-940-8
- EC Name:
- Ethyldimethylamine
- Cas Number:
- 598-56-1
- Molecular formula:
- C4H11N
- IUPAC Name:
- ethyldimethylamine
- Details on test material:
- - Name of test material (as cited in study report): Dimethylethylamine
- Physical state: liquid
- Analytical purity: 99.5%
- Purity test date: 1989-07-20
- Lot/batch No.: 8907P0193
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other: origin: 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 (78950 Gambais, France)
- Age at study initiation: no data
- Weight at study initiation: 345+/-13g (males) and 326+/-17g (females)
- Housing: individually in polycarbonate cage (48x27x20cm)
- Diet (e.g. ad libitum): ad libitum pelleted diet "Cobaye entretien référence 106" (U.A.R. 91360 Villemoisson sur Orge, France)
- Water (e.g. ad libitum): ad libitum drinking water filtered on 0.22µ membrane (Société Millipore, 78140 Velizy, France)
- Acclimation period: at least 5days
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: 1989-09-08 (D1) To: 1989-10-02 (D25)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 0.1 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 1%
- No. of animals per dose:
- Control group: 5males and 5females
Treated group: 10males and 10females - Details on study design:
- RANGE FINDING TESTS:
intradermal: 0.02 and 1%
cutaneous: 1 and 10%
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal induction (D1)
- No. of exposures: 1
- Exposure period: -
- Test groups: -
- Control group: -
- Site: scapular area
- Frequency of applications: -
- Duration: -
- Concentrations:
0.1mL Freund's complete adjuvant 50% in 0.9%NaCl
0.1mL dimethyletylamine 1% (for treated group) or vehicle (for control group)
0.1mL mixture 50/50(V/V) Freund 's complete adjuvant 50% in 0.9%NaCl and Dimethylethylamine (for treated group) or vehicle (for control group)
Cutaneous induction (D8)
- No. of exposures: 1
- Exposure period: -
- Test groups: 0.5mL Dimethylethylamine 1%
- Control group: 0.5mL vehicle
- Site: scapular area
- Frequency of applications: -
- Duration: 48hours occlusive
- Concentrations: -
B. CHALLENGE EXPOSURE
- No. of exposures: -
- Day(s) of challenge: D22
- Exposure period:
- Site: scapular area
- Concentrations: 1%
- Evaluation (hr after challenge): 24 and 48hours after removal of the dressing
0.5mL vehicle on the left flank
0.5mL dimethylethylamine on the right flank - 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:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
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 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
27 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
28 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
29 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
30 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
31 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
32 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
33 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
34 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
35 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Treated |
F |
41 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
42 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
43 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
44 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
45 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
46 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
47 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
49 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
50 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Individual scoring
RF=right flank
LF=left flank
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under these experimental conditions, Dimetylethylamine is considered to be not sensitizing.
- Executive summary:
The delayed contact hypersensivity of Dimethylethylamine (DMEA) was evaluated in Guinea pigs according to the Magnusson and Kligman test.
The induction phase has been realized both by intradermal route on day 1 (DMEA 0.1% in vehicle) and by cutaneous route on day 8 (DMEA 1%) 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 DMEA 1%; the cutaneous reactions were scored 24 and 48 hours after the removal of the dressing.
The body weight gain in treated animals was slightly lower than in control animals. No clinical signs (erythema or oedema) were recorded during the study.
In conclusion, under these experimental conditions, DMEA is considered to be not sensitizing.
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