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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Ascorbic acid
EC Number:
200-066-2
EC Name:
Ascorbic acid
Cas Number:
50-81-7
Molecular formula:
C6H8O6
IUPAC Name:
5-(1,2-dihydroxyethyl)-3,4-dihydroxyfuran-2(5H)-one (non-preferred name)
Specific details on test material used for the study:
- Name of test material: Ascorbic Acid
- CAS number: 50-81-7
- Analytical purity: > 99%
- Impurities (identity and concentrations): not specified
- Isomers composition: > 99% L-Ascorbic Acid
- Lot/batch No.: B 12014

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, 4414 Füllingsdorf, Switzerland
- Age at study initiation: 14 (male) weeks to 15 weeks (female)
- Weight at study initiation: 2.3 (male), 2.2 - 2.3 kg (female)
- Housing: Stainless steel cages equipped with automatic cleaning and drinking system
- Water: ad libitium
- Diet: Pelleted standard Kliba 341, Batch 53/90 rabbit maintenance diet ("Kliba", Klingenthalmuehle AG, 4303 Kaiseraugst, Switzerland)
- Acclimatisation period: 4 days under test conditions after veterenary examination

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Remarks:
shaved and abraded
Vehicle:
water
Remarks:
bi-distilled tap water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
0.5 g was applied to the intact and the abraded skin of the shaved area

VEHICLE: The test item was applied using bi-distilled water as vehicle. Homogeneity of the test article in the vehicle was maintained during treatment using a magnetic stirrer. The preparation was made immediately prior to dosing.

NEGATIVE CONTROL: Not performed

POSITIVE CONTROL: Not performed
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 - 1 male, 2 females
Details on study design:
TEST SITE
- Area of exposure: dorsal fur, 10 x 10 cm
- Coverage: 3 x 3 cm
- Type of wrap if used: Surgical gauze, covered with filter paper and semi-occlusive dressing (dressing wrapped around abdomen and anchored with an elastic bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: With lukewarm tap water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: 1, 24, 48 and 72 hours after the removal of the dressing, gauze patch and the test item
SCORING SYSTEM: Erythema, edema and primary dermal irritation index
- Method of calculation: Mean values and standard deviations were calculated whenever possible.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation response in any animal at any time noted. No destructions or irreversible alterations of the treated skin were observed. No corrosion effect was evident on the skin.
Other effects:
The body weight gain of all rabbits was similar. No acute clinical symptoms were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table: Skin irritation scores

Time period Animal No. Sex Erythema Edema Cummulative score Mean cummulative score
Intact Abraded Intact skin Abraded skin Intact skin Abraded skin Intact skin Abraded skin
1 hour 42 M 0 0 0 0 0 0 0.00 0.00
43 F 0 0 0 0 0 0 0.00 0.00
44 F 0 0 0 0 0 0 0.00 0.00
24 hours 42 M 0 0 0 0 0 0 0.00 0.00
43 F 0 0 0 0 0 0 0.00 0.00
44 F 0 0 0 0 0 0 0.00 0.00
48 hours 42 M 0 0 0 0 0 0 0.00 0.00
43 F 0 0 0 0 0 0 0.00 0.00
44 F 0 0 0 0 0 0 0.00 0.00
72 hours 42 M 0 0 0 0 0 0 0.00 0.00
43 F 0 0 0 0 0 0 0.00 0.00
44 F 0 0 0 0 0 0 0.00 0.00

M = male

F = female

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Ascorbic acid is not irritating to the rabbit's skin.
Executive summary:

The acute skin irritating property of ascorbic acid was tested in vivo according to the OECD test guideline 404 and under GLP conditions. Following a single treatment of intact (and abraded) rabbit skin with ascorbic acid (1.0 g/animal; 3 animals) under semi-occlusive patch for 4 hours, the treated sites were scored at 24, 48, and 72 hours after cessation of the treatment. No irritation was seen in any animal at any reading. The overall irritation score was therefore 0.0 (RCC, 1990). In summary, ascorbic acid caused no skin reactions and GHS criteria for classification are not met.