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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 1997-06-09 to 1997-07-16
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted July 17, 1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
92/69/EEC
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
edition November 1984
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
425-180-1
EC Name:
-
Cas Number:
66170-10-3
Molecular formula:
C6H6O9P.3Na
IUPAC Name:
trisodium (2R)-2-[(1S)-1,2-dihydroxyethyl]-5-oxo-4-(phosphonatooxy)-2,5-dihydrofuran-3-olate
Details on test material:
- Name of test material (as cited in study report): Sodium Ascorbyl Phosphate
- Physical state: Solid (Powder), beige
- Analytical purity: 85.4 g/100 g (HPLC)
- Date of Manufacturing: 1997-05-02
- Lot/batch No.: 28600/37-9
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Weight at study initiation: 3.96 kg
- Housing: single housing, stainless steel wire mesh cages with grating, floor area: 3000 CM2, no bedding in the cages, Sawdust in the waste trays
- Diet (e.g. ad libitum): Kliba-Labordiaet 341, Klingentalmuehle AG, Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (e.g. ad libitum): about 250 ml tap water per animal per day
- Acclimation period: acclimatization for at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12 H/12 H (6.00 A.M. - 6.00 P.M. / 6.00 P.M. - 6.00 A.M.)


IN-LIFE DATES: From: 1997-06-09 To: 1997-06-12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: no vehicle used, but moistened with water
Controls:
other: untreated skin sites of the treated animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 g Substance and has been moistened with aqua bidest because of the natural moisture of the skin, distilled water was used so that the test has been carried out under as physiological conditions as possible

VEHICLE
No vehicle used. Substance was moistened with bidest water (see above).
Duration of treatment / exposure:
4 hrs
Observation period:
72 hrs
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks (2.5 cm x 2.5 cm)
- Type of wrap if used: Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern und Fixomull(R) Stretch (Adhesive fleece), Beiersdorf AG


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test substance was removed at the end of the exposure period with Lutrol and Lutrol/Water ( 1:1 )
- Time after start of exposure: 4 hrs


SCORING SYSTEM:
Erythema and Eschar Formation
no Erythema Erythema..................................................................................................................0
very slight Erythema (Barely perceptible) .................................................................................1
well defined Erythema...................................................................................................................2
moderate to severe Erythema.....................................................................................................3
Severe Erythema (beet redness) to Eschar formation preventing Grading of Erythema...4

Edema formation
no Edema...................................................................................................................................... 0
very slight Edema (barely perceptible) ................................................................................... 1
slight Edema (Edges of area well defined by definiteraising)...............................................2
moderate Edema (raised approx. 1 mm) ............................................................................... 3
severe Edema (raised more than 1 mm and extending beyond area of exposure)......... 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h, 48 h, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h, 48 h, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 h, 48 h, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 h, 48 h, 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h, 48 h, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The average score (24 to 72 hours) for irritation was calculated to be 0.6 for Erythema and 0.0 for Edema. The skin findings were reversible in all animals within 72 hours after removal of the patches, thus the study was terminated. Symptoms observed together with the average score for irritation do not indicate an irritant property of the test substance to the skin.
Other effects:
No mortality.

Any other information on results incl. tables

Readings

Animal

Erythema

Edema

Symptoms

1 h

01

2

0

10

02

1

0

10

 -

03

1

0

10

 -

04

1

0

10

 -

05

2

0

10

 -

06

1

0

10

24 h

01

2

0

10

 -

02

1

0

10

 -

03

1

0

10

 -

04

1

0

10

 -

05

2

0

10

 -

06

1

0

10

48 h

01

1

0

10

 -

02

0

0

-

 -

03

0

0

-

 -

04

0

0

-

 -

05

0

0

-

 -

06

1

0

10

72 h

01

0

0

-

 -

02

0

0

-

 -

03

0

0

-

 -

04

0

0

-

 -

05

0

0

-

 -

06

0

0

-

mean

01

1.0

0.0

-

 -

02

0.3

0.0

-

 -

03

0.3

0.0

-

 -

04

0.3

0.0

-

 -

05

0.7

0.0

-

 -

06

0.7

0.0

-

mean

 -

0.6

0.0

-

EXPLANATION OF SYMPTOMS

10 : Mechanical skin lesions due to adhesive test substance

CALCULATION OF MEAN VALUES:

Calculation of the mean according to 93/21/EEC criteria of April 27th, 1993 (for calculation of the means of Erythema and Edema only the readings of 24, 48 and 72 hours are used).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test substance sodium ascorbyl phosphate is not irritating to the rabbit skin.