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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1991-02-01 to 1991-06-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, OECD guideline n°404 (1981 May 12th)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
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
- Substance type: pure active substance
- Physical state: liquid
- Analytical purity: 99.49%
- Purity test date: 1991-01-22
- Lot/batch No.: P90.11
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: stored at romm temperature and kept away from light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage cunicole du val de Selle, 80160 Prouzel, France
- Age at study initiation: no data
- Weight at study initiation: 2500+/-100 g
- Housing: individually
- Diet (e.g. ad libitum): ad libitum pellet diet "Rabbits sustenanceref.112C (U.A.R., 91360 Villemoisson-sur-Orge, France)"
- Water (e.g. ad libitum): ad libitum tap water filtered by a 0.22µ filter membrane (Cociété Millipore, 78140 Vélizy, France)
- Acclimation period: at least 5 days before treatment
- Other: Male rabbits were used


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 50+/-20%
- Air changes (per hr): non recycled and filtered with absolute filters
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL undiluted
Duration of treatment / exposure:
4 hours (n=3) and 3 minutes (n=1)
Observation period:
1, 24, 48, 72hours then daily until day 15
Number of animals:
4 in total
Details on study design:
TEST SITE
- Area of exposure: 6cm² dry gauze patch (Semes France, 54183 Heillecourt, France)
- Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressing (Laboratoires de Pansements et d'hygiène, 21300 Chenôve, France) attached to a gauze bandage (Promotion médicale, 27000 Evreux, France)

SCORING SYSTEM: according to the OECD guideline n° 404 (1981 May 12th)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
4-hour exposure
Basis:
animal: #1, 2 and 3
Time point:
other: 24, 48 hours
Reversibility:
not reversible
Remarks:
, sacrificed on D2 for humanitarian reasons
Remarks on result:
other: Necrosis
Irritation parameter:
edema score
Remarks:
4-hour exposure
Basis:
animal #1
Time point:
other: 24, 48 hours
Score:
2
Max. score:
4
Irritation parameter:
edema score
Remarks:
4-hour exposure
Basis:
animal: #2 and 3
Time point:
other: 24, 48 hours
Score:
4
Max. score:
4
Irritation parameter:
erythema score
Remarks:
3-min exposure
Basis:
animal #4
Time point:
other: D1 to D15
Reversibility:
not reversible
Remarks on result:
other: Necrosis
Irritation parameter:
edema score
Remarks:
3-min exposure
Basis:
animal #4
Time point:
other: 24, 48 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
The application of the test substance during 4 hours (animals O1 to O3) has induced a tissular destruction on the whole depth of the skin the 3 animals which were sacrificed for humanitarian reasons.
After the application of the test substance during 3 minutes (animal O4), severe erythema to slight eschar formation (superficial necrosis) was observed after one hour and then was irreversible during 14 days. A slight oedema (score 2) was noted during 24 hours.

Any other information on results incl. tables

Individual scoring

TD=Tissue Destruction N=Necrosis

 

D1

D2

D3

D4

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

D15

Erythema

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

O1

TD

TD

-

-

-

-

-

-

-

-

-

-

-

-

-

O2

TD

TD

-

-

-

-

-

-

-

-

-

-

-

-

-

O3

TD

TD

-

-

-

-

-

-

-

-

-

-

-

-

-

O4

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

Oedema

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

O1

2

2

-

-

-

-

-

-

-

-

-

-

-

-

-

O2

4

4

-

-

-

-

-

-

-

-

-

-

-

-

-

O3

4

4

-

-

-

-

-

-

-

-

-

-

-

-

-

O4

2

2

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
Category 1A (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DIMETHYLDIPROPYLENETRIAMINE has to be labelled as corrosive in rabbits.
Executive summary:

The acute dermal irritation of Dimethyldipropylenetriamine (DMAPAPA) was evaluated in male New Zealand White rabbits according to OECD N° 404 Guideline. 0,5mL of DMAPAPA was applied during 4 hours in 3 rabbits and during 3 minutes in 1 rabbit on clipped area. The cutaneous reaction was observed 1, 24, 48, 72 hours after removal of the dressing and then daily to day 15 (for 1 animal).

After application of the substance during 4 hours, tissular destruction on the whole depth of the skin was observed in the three animals, which were sacrificed for ethical reasons. The application of DMAPAPA during 3 minutes induced a severe erythema and a slight eschar formation in 1 hour that were irreversible during 14 days. A slight oedema was noted during 24 hours.

Under these experimental conditions, DMAPAPA has to be classified as corrosive in rabbits.