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EC number: 425-180-1 | CAS number: 66170-10-3
Skin irritation / corrosion
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:
- 1 997
- 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
- 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
Constituent 1
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.
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