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Description of key information

DMIPA was considered as non skin sensitizing in an OECD 406 performed according to GLP (Magnusson and Kligman).

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
Study period:
end 1986-07-20
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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:
An OECD 406 was performed before implementation of the LLNA method.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Iffa credo, Les Oncins, 69120 L'arbresle, France, and
Bantin et Kingman, aldbrough Hull, HU 4QE Great Britain, and
David Hall, Burton on Trent DE 13 8RJ, Great Britain, and
Shamrock Bioservices, 12, rue de Saint Côme, 78950 Gambais, France.
- Age at study initiation: no data
- Weight at study initiation: 300-500g
- Housing: by groups of 5 in polystyrene cages (56x35.5x31.5cm) with perforated floor
- Diet (e.g. ad libitum): ad libitum guinea pig completepelleted maintenance food (Extra Labo formule "C.15.50 - Ets Pietrement, Sainte Colombe - 77650 Longueville- France)
- Water (e.g. ad libitum): Ad libitumsoftened and filtered (15µ) drinking water
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: no data
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
1st administration: Induction 0.25 % intracutaneous
2nd administration: Induction 5 % occlusive epicutaneous
3rd administration: Challenge 2.5 % occlusive epicutaneous
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
1st administration: Induction 0.25 % intracutaneous
2nd administration: Induction 5 % occlusive epicutaneous
3rd administration: Challenge 2.5 % occlusive epicutaneous
No. of animals per dose:
5males and 5females (control group)
10males and 10females (treated group)
Details on study design:
RANGE FINDING TESTS:
intracutaneous: 0.25, 0.5, 1%
epicutaneous: 1, 2.5, 5, 10%
epicutaneous

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 DMIPA 0.25% 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 DMIPA 0.50% in 0.9% NaCl (for treated group)

Cutaneous induction D8
. On day 8, the irritation created with the application of sodium Laurylsulfate 10% in vaseline.
. On day 9, occlusive application on the scapular area of 0.5mL of the test item 5% (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 2.5% on the right flank and 0.5mL of the vehicle on the left flank.
Reactions are evaluated 6, 24 and 48 hours after removal of the dressing.

Dihydrocoumarine (100% sensitization), Paraphenylenediamine (55%), Formol (70%), Penicilline G(70%), Benzocaine (45%), Propyleneglycol (0%)
Positive control substance(s):
yes
Reading:
1st reading
Hours after challenge:
6
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: 6.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd 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: 2nd reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
other: 3rd 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: other: 3rd 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:
6
Group:
test chemical
Dose level:
2.5
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 6.0. Group: test group. Dose level: 2.5. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
2.5%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Interpretation of results:
GHS criteria not met
Conclusions:
In these experimental conditions, DMIPA is considered as not sensitizing in guinea pigs.
Executive summary:

The delayed contact hypersensivity of Dimethylisopropylamine (DMIPA) was evaluated in Guinea pigs according a protocol similar to OECD N°406 guideline (Magnusson and Kligman test).

The induction phase has been realized both by intradermal route on day 1 (DMIPA 0.25 % in water) and by cutaneous route on day 9 (DMIPA 5%) 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 DMIPA 2.5 %; the cutaneous reactions were scored 6, 24 and 48 hours after removal of the dressing.

A female guinea pig from control group has been found dead 24hours after the challenge exposure. No cutaneous reaction was observed in the other 29 animals after the challenge exposure.

In conclusion, Dimethylisopropylamine was considered as not sensitizing in guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
The delayed contact hypersensivity of N,N-dimethylisopropylamine (DMIPA) was evaluated in Guinea pigs according a protocol similar to OECD N°406 guideline (Magnusson and Kligman test) (Guillot, 1986). The induction phase has been realized both by intradermal route on day 1 (DMIPA 0.25 % in water) and by cutaneous route on day 9 (DMIPA 5%) 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 DMIPA 2.5 %; the cutaneous reactions were scored 6, 24 and 48 hours after removal of the dressing. A female guinea pig from control group has been found dead 24hours after the challenge exposure. No cutaneous reaction was observed in the other 29 animals after the challenge exposure. In conclusion, Dimethylisopropylamine was considered as not sensitizing in guinea pigs.

Migrated from Short description of key information:
In a maximization assay, N,N-dimethylisopropylamine was not sensitizing in guinea pigs.

Justification for selection of skin sensitisation endpoint:
Key study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:
Migrated from Short description of key information:
This information is not available.

Justification for classification or non-classification

In a test performed following the GPMT's method, N,N-dimethylisopropylamine didn't induce skin sensitiziation in guinea pigs. On the basis of this study and in accordance with Regulation (EC) No 1272/2008 and with Annex VI of Commission Directive 2001/59/EC, no classification is warranted for skin sensitization.