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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:
27.3.-11.4.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was carried out in accordance with internationally valid GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Potassium permanganate
- Molecular formula (if other than submission substance): KMnO4
- Molecular weight (if other than submission substance): 158.03
- Batch No.: 69
- Substance type: technical product
- Physical state: solid crystals
- Analytical purity: 99.42 % wt.
- Impurities (identity and concentrations): Manganese dioxide ca 0.1 % wt.
- Appearance: dark violet-purple crystalline powder with bronze lustre
- pH: 1% solution-6.1

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: breeding farm BioTest s. r. o., Konárovice 281, Czech Republic
- Weight at study initiation: 2.6 kg
- Age at study initiation: 3-4 months
- Housing: individually in cages without bedding in conventional animal room
- Diet (e.g. ad libitum): pelleted standard diet TM-MAK 1 for rabbits and guinea-pigs ad libitum, made by Bergman, Kocanda Mill, 252 42 Jesenice u Prahy
- Water: drinking tap water, ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: 7days
- Identification of animals: code number on inner side of ear of animal, number of study on each cage
-Health condition: certificate of good health condition – from breeding farm; no signs of diseases were observed at clinical check-in,
in acclimatization period and before the start of experiment.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23 °C, permanently monitored
- Humidity (%): 30 - 70 %, permanently monitored
- Air changes (per hr): approximatly 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

Study time schedule
Animal supply: 20. 3. 2006
Experimental part of study: 27. 3. – 11. 4. 2006
Evaluation of results and final report elaboration: 12. 4. – 28. 4. 2006

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): The test substance was weighed (0.5 g) and applied in delivered form.
- Concentration (if solution): only moistened with smallest amount of water
- Application of the test substance: The test substance was covered by gauze patch, foil and cellulose cotton and held in place with non-irritating tape - Spofaplast

Duration of treatment / exposure:
3min
1hour
4 hour
Observation period:
Skin reaction were evaluated after patch removal and at 1, 24, 48 and 72 hours after exposure.
The test animal was observed for 14 days of the observation period (according to guideline).
Number of animals:
1
Details on study design:
TEST SITE
- Area of exposure: fur from area 6x6 cm was removed
- % coverage: is not mentioned in study report
- Type of wrap if used: gauze patch, foil and cellulose cotton held in place with non-irritating tape Spofaplast

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of each exposure period patch was removed and remaining sample was washed with water
- Time after start of exposure: 1st patch - 3 minutes
2nd patch - 1 hours
3rd patch - 4 hours

Exposed rabbit was examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal.
During the 14 days observation period, the lesion on the skin was almost healed without complications (gleet, erythema and oedema). It is possible to predict, that if the observation period will last for further few days, the lesion would be full healed.

SCORING SYSTEM: According to EU method B.4 Acute Toxicity: Dermal Irritation/Corrosion

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritation parameter:
edema score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritation parameter:
edema score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: full thickness destruction of skin occurred
Irritant / corrosive response data:
See table No. 1
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
No histopathology was performed.

Any other information on results incl. tables

Table No. 1 Skin reactions in experimental animals –grades

Time after

 4-hours exposure

Observation

Rabbit No. 1

 

1 hour

Erythema      0

 Oedema       0

Full thickness destruction of skin tissue occurs

24 hours

Erythema      1

 Oedema       0

Lesion – dry, without gleet

Surroundings of the lesion – slight erythema, no oedema

48 hours

 Erythema     1

 Oedema       0

Lesion – dry, without gleet

Surroundings of the lesion – slight erythema, no oedema

72 hours

Erythema      4

 Oedema       0

Lesion - dry, crust, eschar formation

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance Potassium permanganate was tested for acute dermal irritation/corrosion.
After 4-hour exposure of the test substance on the intact skin of the test animal, full thickness destruction of skin tissue occurs. Then the testing was stopped – no other animal was used.
No extinction of corrosive lesions was recorded in 72 hours after exposure, the test animal was then observed until the end of observation period (14 days). During the 14-day observation period, the lesions on the skin were almost healed without complications.
No other signs of intoxication were observed.
Executive summary:

The test substance Potassium permanganate was tested in the study for acute dermal irritation/corrosion. Rabbit (New Zealand Albino breed) was used for the test.

Test was performed according to EU method B.4 Acute Toxicity: Dermal Irritation/Corrosion, which is analogous to OECD Test Guideline No. 404 Acute Dermal Irritation/Corrosion.

 

One rabbit was exposed to 0.5 g of the test substance, applied onto clipped skin for 3 minutes, 1 hour and 4 hours using a semi-occlusive dressing. Skin reactions were evaluated after patch removal and at 1, 24, 48 and 72 hours after exposure.

At 3-minute and 1-hour exposure no skin lesions were observed after removing of the patch.

After 4-hour exposure of the test substance on the intact skin of the test animal, full thickness destruction of skin tissue occurs. Then the testing was stopped – no other animal was used.

No extinction of corrosive lesions was recorded in 72 hours after exposure, the test animal was then observed until the end of observation period (14 days). During the 14-day observation period, the lesions on the skin were almost healed without complications.

No other signs of intoxication were observed.