Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
27.03.2006 - 11.04.2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the guideline.

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
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
Appearance of Potassium permanganate: dark violet - purple crystalline powder with bronze lustre, pH of 1% solution was 6.1.

Potassium permanganate has been used as a surrogate for sodium permanganate where data are not available. Read-across from potassium permanganate to sodium permanganate is appropriate from the toxicological point of view as the most toxicologically relevant part of the substances is the same (permanganate). The contribution of the sodium/potassium ions to the toxicity of the respective substances is likely to be minimal. The toxicity of both substances is therefore likely to be very similar and will be dominated by local (site of contact) irritant/corrosive effects and systemic toxicity due to the absorption of manganese ions. This toxicophore similarity is adequate justification for waiving the conduct of specific studies with sodium permanganate and the dossier reflects this waiving proposal by including summaries of read-across studies where appropriate.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The source of the rabbit was from a breeding farm, BioTest s.r.o., Konarovice, 281 25, Czech Republic, RCH CZ 21760152. One female rabbit, weighing 2.6 kg prior to the application and 3.0 kg at completion, 7 days of acclimitisation housed in a individual cage in a conventional animal room with unrestricted drinking water. No signs of disease were observed at clinical check-in, during the acclimitisation period or at the start of the experiment.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: moistened with the smallest amount of water
Controls:
no
Amount / concentration applied:
The test substance was weighed (0.5g) and moistened with the smallest amount of water, then applied onto intact skin and covered by a gauze patch, foil and cellulose cotton and held in place with non-irritating tape (Spofaplast).
Duration of treatment / exposure:
Three patches were first applied sequentially to one animal (rabbit no 1) in the initial test. The first patch was removed after three minutes. No serious skin reaction was observed, so the second patch was applied for one hour. The observations indicated that exposure can humanely be allowed to extend to four hours, so the third patch was applied for four hours. After removing the patch, a response was graded. Because the corrosive effect was observed after a 4 hour exposure, the testing was stopped and no other test animal was used.
Observation period:
The exposed rabbit was examined for signs of erythema and oedema at 1, 24, 48 and 72 hours after patch removal. Dermal irritation was scored and recorded according to the Table of Grading for skin reactions (see Table below).
Number of animals:
1 female rabbit
Details on study design:
Clinical observation of the animal was carried out before application and then daily during the study.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 0-72h
Score:
>= 1 - <= 4
Max. score:
4
Reversibility:
other: almost fully reversible within 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-72h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Potassium permanganate applied at 0.5g caused full destruction of the skin tissue after 4 hours, therefore the testing was stopped and no further animals were used. No extinction of corrosive lesions was recorded following 72 hours after exposure, and during the 14 day observation period, the lesions on the skin were almost healed without complications. No other signs of intoxication were recorded.
Other effects:
No further information provided.

Any other information on results incl. tables

Skin reactions in the experimental animal

Time after 4-hours exposure

Observation

Rabbit No 1

 

1 hour

Erythema 

Oedema

0

0

Full thickness destruction of skin tissue occurs

24 hours

Erythema 

Oedema

1

0

Lesion – dry, without discharge

Surroundings of the lesion – slight erythema, no oedema

48 hours

Erythema 

Oedema

1

0

Lesion – dry, without discharge

Surroundings of the lesion – slight erythema, no oedema

72 hours

Erythema 

Oedema

4

0

Lesion – dry, crust, eschar formation

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results the test substance Potassium permanganate is classified as corrosive and the risk phrase 'R34: causes burns' should be assigned.
Executive summary:

One female Albino New Zealand rabbit was used in this study. 0.5 g of potassium permanganate was applied directly to the clipped, intact skin of the rabbit for 4 hours. A 14-day observation period followed application. Potassium permanganate applied at 0.5g caused full destruction of the skin tissue after 4 hours, therefore the testing was stopped and no further animals were used. No extinction of corrosive lesions was recorded following 72 hours after exposure, and during the 14 day observation period, the lesions on the skin were almost healed without complications. No other signs of intoxication were recorded.

Based on the results the test substance Potassium permanganate is classified as corrosive and the risk phrase 'R34: causes burns' should be assigned.