Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
04.04.2006 - 20.04.2006
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.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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 is dark violet - purple crystalline powder with bronze lustre. The pH of the 1% solution is 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:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Rats were sourced from a breeding farm (BioTest s.r.o., Konarovice, 281 25 CZ RCH CA 21760152. Weight of the animals was 199.14-318.21 g. Rats were acclimatised for 15 days and housed in an animal room, one animal per cage. Ad libtum drinking tap water, room temperature of 22±3oC and relative humidity of 30-70% (both permanently monitored), 12 hour light/12 hour dark. Animals were checked for signs of disease during the acclimitisation period before the start of the study.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: test substance was moistened with the smallest amount of water
Details on dermal exposure:
Approximately 24 hours before application, the fur on the back of the animals was shaved to an area of 6x6cm, and immediately before application the animals were weighed. The test substance in delivered form (moistened with the smallest amount of water) was applied on the depilated area of the skin. The applcation site was covered by mull, plastic foil and held in contact by a plaster strapping. After 24 hours the occlusive dressing and remains of the test substance were removed with water.
Duration of exposure:
24 hours
Doses:
The study was performed as a limit test with a dose level of 2000 mg/kg.
No. of animals per sex per dose:
Two groups of animals; 5 males and 5 females.
Control animals:
no
Details on study design:
10 Wistar rats were used in this study (5 males and 5 females). Potassium permanganate was applied at a dose of 2000 mg/kg bw directly to the clipped, intact skin of the rats for 24 hours. A 14-day observation period followed application. Potassium permanganate applied at 2000 mg/kg bw did not cause any mortalities, and macroscopic changes were diagnosed during pathological examination in all animals.
Statistics:
Not relevant.

Results and discussion

Preliminary study:
No preliminary study reported.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: No deaths occurred during the 14 day observation period.
Mortality:
No deaths occurred during the 14 day observation period.
Clinical signs:
After application the animals were observed individually - the first day: twice (30 minutes and 3 hours after application), the second day: twice (in the morning and afternoon) and daily thereafter for 14 days. Observations included changes in skin and fur, eyes, viscous mucous membranes, nutritive condition, autonomic and central nervous systems, somatomotor activity, reactions to stimuli, function of respiratory, circulatory, digestive and urogenital system. Also the presence of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma was carefully observed.
Results showed no clinical signs of toxicity was observed during the study in all animals.
Body weight:
The animals were weighed at the start of the study (before application), at day 8 and at the end of the experiment (day 15). Average body weight was calculated from individual body weights. Body weight increments were calculated from body weight at the start of the study and at the end of the study. Weight increments in males were in physiological range (average increment of 63.70 g), only body weight gains of females were markedly lower (average increment of 24.42 g).
Gross pathology:
On day 15 of the study, all test animals were sacrificed (by injection of veterinary formulation T61, 1ml/animal) and gross necropsy was carried out. Size, colour, shape, structure and consistency of the organs was evaluated, and all gross macroscopic changes of organs and tissues were also recorded.
Other findings:
No other findings reported.

Any other information on results incl. tables

Summary table of toxic effects

Dose (mg/kg)

Number and sex of animals

Mortality

Clinical signs of intoxication

Pathological findings

2000

5 males

0

0

5

2000

5 females

0

0

5

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Potassium permanganate did not fall into any of the quoted catagories of toxicity and therefore has no obligatory labelling requirement Criteria used for interpretation of results: EU
Conclusions:
10 Wistar rats were used in this study (5 males and 5 females). Potassium permanganate was applied at a dose of 2000 mg/kg bw directly to the clipped, intact skin of the rats for 24 hours. A 14-day observation period followed application. Potassium permanganate applied at 2000 mg/kg bw did not cause any mortalities, and macroscopic changes were diagnosed during pathological examination in all animals. The acute dermal LD50 was found to be >2000 mg/kg bw under the conditions of this study.
Executive summary:

10 Wistar rats were used in this study (5 males and 5 females). Potassium permanganate was applied at a dose of 2000 mg/kg bw directly to the clipped, intact skin of the rats for 24 hours. A 14-day observation period followed application. Potassium permanganate applied at 2000 mg/kg bw did not cause any mortalities, and macroscopic changes were diagnosed during pathological examination in all animals. The acute dermal LD50 was found to be >2000 mg/kg bw under the conditions of this study.