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EC number: 220-816-2 | CAS number: 2906-12-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- end 1998-05-28
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, OECD 406 (July 17th 1992)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (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 reach regulation.
Test material
- Reference substance name:
- 3-isopropoxypropylamine
- EC Number:
- 220-816-2
- EC Name:
- 3-isopropoxypropylamine
- Cas Number:
- 2906-12-9
- Molecular formula:
- C6H15NO
- IUPAC Name:
- 3-(propan-2-yloxy)propan-1-amine
- Details on test material:
- - Name of test material (as cited in study report): 3-isopropoxypropylamine
- Physical state: liquid
- Analytical purity: 99.78%
- Purity test date: 1997-08-07
- Lot/batch No.: 9708P0073
- Expiration date of the lot/batch: December 1998
- Stability under test conditions: no data
- Storage condition of test material: at room temperature and protected from light
- Other: origin: Usine de Maurienne, 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: Charles River France, 76410 Saint Aubin lès Elbeuf, France
- Age at study initiation: approx. 3months old
- Weight at study initiation: 353+/-10g (males) and 355+/-21g (females)
- Housing: individually in polycarbonates cages (48x27x20cm)
- Diet (e.g. ad libitum): ad libitum 106pelleted diet (U.A.R. 91360 Villemoisson sur Orge, France)
- Water (e.g. ad libitum): ad libitum drinking water filtered with a F.G. Millipore (0.22µ)
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21+/-2°C
- Humidity (%): 30-70%
- Air changes (per hr): approx. 12 cycles
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1997-10-09 To: 1997-11-10
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 0.1%
cutaneous induction: 25%
cutaneous challenge:10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- intradermal induction: 0.1%
cutaneous induction: 25%
cutaneous challenge:10%
- No. of animals per dose:
- control group: 5males and 5females
treated group: 10males and 10females - Details on study design:
- RANGE FINDING TESTS: determination of the maximum non irritant concentrations
Intradermal: injection of 0.1mL of formulations at 0.1, 1, 5 and 10mg/kg +/-FCA on clipped area. Evaluation of cutaneous reactions at 24 and 48hours after removal of the dressing.
Cutaneous: occlusive application for 24h of 0.5mL of formulations at 5, 10, 25 and 50mg/kg on clipped area. Evaluation of cutaneous reactions at 24 and 48hours after removal of the dressing.
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 IPOPA 0.1% in 0.9% NaCl (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 IPOPA 0.1% in 0.9% NaCl (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 IPOPA 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 IPOPA 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:
- Dinitrochlorobenzene and Mercaptobenzothiazole
Results and discussion
- Positive control results:
- CIT Study N°16065 TSG: Spetember 1997. Under these experimental conditions, Dinitrochlorobenzene at the concentration of 1% induced positive skin sensitization reactions in 90% of the guinea pigs. Mercaptobenzothiazole at the concentration of 20% induced positive skin reaction in 30% of the guinea pigs.
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
- 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.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- 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: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 13.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- dryness of the skin (14/20), crusts (1/20)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: dryness of the skin (14/20), crusts (1/20).
Any other information on results incl. tables
Scoring of skin reactions
LF=left flank
RF=right flank
S=dryness of the skin
A=crusts
Group |
Sex |
Animal |
24h |
48h |
||||||
Erythema |
Oedema |
Erythema |
Oedema |
|||||||
LF |
RF |
LF |
RF |
LF |
RF |
LF |
RF |
|||
Control |
M |
136 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
137 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
138 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
139 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
140 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Control |
F |
141 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
142 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
143 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
144 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
145 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||
|
||||||||||
Treated |
M |
146 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
147 |
0 |
2 |
0 |
2 |
0 |
2/S |
0 |
0 |
||
148 |
0 |
1 |
0 |
0 |
0 |
1/S |
0 |
0 |
||
149 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
150 |
0 |
2 |
0 |
2 |
0 |
1/S/A |
0 |
0 |
||
151 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
152 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
153 |
0 |
2 |
0 |
2 |
0 |
1/S |
0 |
0 |
||
154 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
155 |
0 |
1 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
|
||||||||||
Treated |
F |
156 |
0 |
2 |
0 |
0 |
0 |
1/S |
0 |
0 |
157 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
158 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
159 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
160 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
161 |
0 |
1 |
0 |
0 |
0 |
1/S |
0 |
0 |
||
162 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
163 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||
164 |
0 |
2 |
0 |
0 |
0 |
0/S |
0 |
0 |
||
165 |
0 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
||
Applicant's summary and conclusion
- Interpretation of results:
- other: sensitising Cat. 1A
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- 3-Isopropoxyproylamine induces delayed contact hypersensitivity in 65% and should be considered as a strong sensitiser.
- Executive summary:
The delayed contact hypersensivity of 3-isopropoxypropylamine (IPOPA) was evaluated in Guinea pigs according a protocol similar to OECD N°406 guideline (Magnusson and Kligman test) (Manciaux, 1998b). The induction phase has been realized both by intradermal route on day 1 (IPOPA 0.1% in vehicle) and by cutaneous route on day 8 (IPOPA 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 IPOPA 10%; the cutaneous reactions were scored 24 and 48 hours after the challenge phase. No cutaneous reaction was observed in the animals of the control group. In the treated group, a very slight or well-defined erythema (grade 1 or 2) was noted at the 24hour reading in 6/20 and 13/20 guinea pigs respectively. A slight oedema (grade 2) was recorded in 3/20 animals. At the 48hour reading, a very slight or well-defined erythema (grade 1 or 2) persisted in 5/20 and 1/20 animals respectively. Dryness of the skin was observed in 14/20 animals and crusts were noted in one animal. 3-isoproxypropylamine induces delayed contact hypersensitivity in 65% and should be considered as a strong sensitiser.
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