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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
end 2004-01-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The temperature and relative humidity recorded in the animal room were somtetimes outside of the target ranges specified in the Study plan. The test item was not protected from light.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyldiisopropylamine
EC Number:
230-392-0
EC Name:
Ethyldiisopropylamine
Cas Number:
7087-68-5
Molecular formula:
C8H19N
IUPAC Name:
ethylbis(propan-2-yl)amine
Details on test material:
- Name of test material (as cited in study report): Ethyldiisopropylamine
- Physical state: liquid
- Analytical purity: 99.65%
- Purity test date: 2002-10-09
- Lot/batch No.: JT010101
- Expiration date of the lot/batch: June 2004
- Stability under test conditions: no data
- Storage condition of test material: in dark, protected from moisture and at temperature < 50°C
- Other: Atofina-La Chambre

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: CEVAG, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 month old
- Weight at study initiation: 3.1+/-0.1kg
- Housing: indidually in polystyrene cages (48.2x58x36.5cm)
- Diet (e.g. ad libitum): ad libitum 110 pellet diet (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum water filtered by a FG Miliipore membrane (0.22µ)
- Acclimation period:at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3°C
- Humidity (%): 30-70%
- Air changes (per hr): approximately 12 cycles / hour
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: To: 2003-08-12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: auto-control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5mL
Duration of treatment / exposure:
3 minutes and 4 hours
Observation period:
1 hour, 24, 48, 78 hours after removal of the dressing then daily until D15.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: no data
- Type of wrap if used: dry gauze pad held in contact by an adhesive hypoallergenic aerated semi occlusive dressing and a restraining bandage.

SCORING SYSTEM: according to the OECD N°404 Guideline scoring scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: 3min of exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 3-min exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 11 days
Remarks on result:
other: 4-hour exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: 4-hour exposure
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Remarks on result:
other: 4-hour exposure
Irritation parameter:
edema score
Basis:
animal: #1, 2 and 3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: 4-hour exposure
Irritant / corrosive response data:
After a 3-minute exposure (one animal), a very slight or slight erythema (grade 1 or 2) was observed from day 1 up to day 14. Dryness of the skin was noted from day 6 up to the end of the observation period (day 15).
After a 4-hour exposure (three animals), a very slight or slight erythema (grade 1 or 2) was recorded in all animals from day 1 up to day 10 or 12. A slight oedema (grade 2) was noted in 1/3 animals on days 5 and 6. Dryness of the skin, sometimes together with crusts in 1/3 animals, was also observed in 2/3 animals between days 5 and 10 or between days 6 and 12.

Any other information on results incl. tables

3 min exposure

1h

24h

48h

72h

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

D15

Erythema

951

1

1

2

2

2

2

2

2

2

2

1

1

1

1

0

Oedema

951

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Other

951

*

*

*

*

*

S

S

S

S

S

S

S

S

S

S

* = none

S = dryness of the skin

 

4 h exposure

1h

24h

48h

72h

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

D15

Erythema

951

1

1

2

2

2

1

1

1

1

1

0

-

-

 

 

 

926

2

2

2

2

2

2

2

1

1

1

1

1

0

 

 

 

927

2

2

2

2

2

2

2

2

2

2

1

1

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oedema

951

0

0

0

0

0

0

0

0

0

0

0

-

-

 

 

 

926

0

0

0

0

2

2

0

0

0

0

0

0

0

 

 

 

927

0

0

0

0

0

0

0

0

0

0

0

0

0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

951

*

*

*

*

*

*

*

*

*

*

*

-

-

 

 

 

926

*

*

*

*

S

S

S

S

S

S

*

*

*

 

 

 

927

*

*

*

*

*

S

S

S/A

S/A

S/A

S

S

*

 

 

 

* = none

S = dryness of the skin

A = crust

- = cutaneous examination performed

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information not classified according to CLP, R38 according to DSD Criteria used for interpretation of results: EU
Conclusions:
Mean scores over 24, 48 and 72 hours for each animal were 1.7, 2.0 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Executive summary:

The dermal irritation of Ethyldiisopropylamine (EDIPA) was evaluated in male New Zealand White rabbits according to OECD N°404 Guideline.

0,5mL of EDIPA was applied during 4 hours in 3 rabbits and during 3 minutes in 1 rabbit on clipped area. The cutaneous reaction was observed one hour, 24, 48, 72 hours after removal of the dressing and then daily to day 15.

After a 3-minute exposure of 0.5mL of EDIPA (one animal), a very slight or slight erythema was observed from day 1 up to day 14. Dryness of the skin was noted from day 6 up to the end of the observation period (day 15). After a 4-hour exposure (three animals), a very slight or slight erythema was recorded in all animals from day 1 up to day 10 or 12. A slight oedema was noted in 1/3 animal on days 5 and 6. Dryness of the skin, sometimes together with crusts in 1/3 animal, was also observed in 2/3 animals between days 5 and 10 or between days 6 and 12.

Mean scores over 24, 48 and 72 hours for each animal were 1.7, 2.0 and 2.0 for erythema and 0.0, 0.0 and 0.0 for oedema.