Pentapotassium bis(peroxymonosulphate) bis(sulphate)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001-01-04 - 2001-09-03

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Pentapotassium bis(peroxymonosulphate) bis(sulphate)

EC Number:

274-778-7

EC Name:

Pentapotassium bis(peroxymonosulphate) bis(sulphate)

Cas Number:

70693-62-8

Molecular formula:

H3K5O18S4

IUPAC Name:

pentapotassium bis((hydroperoxysulfonyl)oxidanide) hydrogen sulfate sulfate

Test material form:

solid

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan U. K. Ltd, Bicester, Oxon, UK
- Age at study initiation: 8 11 weeks
- Weight at study initiation: 234 g (males); 216 g (females)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: distilled water

Details on dermal exposure:

TEST SITE
Area of exposure: approx. 10 % of the total body surface

REMOVAL OF TEST SUBSTANCE
Removal of dressing 24 hours after topical application of test substance. Skin was washed with warm water. The treated area was blotted dry with absorbent paper.

TEST MATERIAL
- Amount(s) applied: 1.20 mL test substance dilution/kg bw (corresponding to 2000 mg/kg bw)
- Concentration (in vehicle): 166.7 % w/v (corresponding to 1.667 g/mL)

Duration of exposure:

24 hours

Doses:

1.20 mL test substance dilution/kg bw (corresponding to 2000 mg/kg bw)

No. of animals per sex per dose:

5 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Toxicity was estimated without use of a statistic model

Results and discussion

Preliminary study:

not indicated

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

male/female

Dose descriptor:

other: LOAEL

Effect level:

2 000 mg/kg bw

Mortality:

No lethal effect at maximal dose.
LD50: > 2000 mg/kg bw

Clinical signs:

other: No deaths and no systemic response to treatment (please refer to Table 1, which is presented under "Remarks on results including tables and figures"). Severe dermal irritation was seen in three animals following removal of the dressings persisting until s

Gross pathology:

Macroscopic examination revealed a necrotic area on the dose site of three animals and scabbing on the dose site of two animals. No abnormalities were recorded for the remaining animals.

Other findings:

- No deaths occurred during the entire study period
- Loss of body weight was recorded for one female and low body weight gains were recorded for two females on day 8

Any other information on results incl. tables

Table 1: Summary of Acute Dermal Toxicity

ose [mg/kg bw]	Sex	Number of dead / number of investigated	Time of death (range)	Observations
2000	male	0/5	n.a.	-        No clinical signs of systemic toxicity, local irritations at the application site, no effect on body weights and necrotic area or scabbing on the dose site in some animals
2000	female	0/5	n.a.	-        No clinical signs of systemic toxicity, local irritations at the application site, loss of body weight in one and low body weight gains in two animals and necrotic area or scabbing on the dose site in some animals
LD50 value	> 2000 mg/kg bw

 

Table 2: Dermal reactions

Dose (mg/kg)

Sex

Animal No.

Erythema / Oedema

Day

2

3

4

5

6

7

8

9

10

11

12

13

14

15

2000

male

1

E O

ef 0

bf 2

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

2

E O

2ac 1f

0a 1

0a 1

0a 1

0a 1

0a 1

0c 0

0c 0

0c 0

0c 0

0c 0

0c 0

0c 0

0c 0

3

E O

1c 0

1c 0

1c 0

0c 0

0c 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

4

E O

1d 1

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

5

E O

ef 4

bf 4

bf 3

bf 2

bf 2

bf 1

bf 2

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

female

6

E O

1c 1

1a 1

1a 1

0a 1

0a 1

0a 1

0c 0

0c 0

0c 0

0c 0

0c 0

0c 0

0 0

0 0

7

E O

2d 2

b 2

b 2

bf 2

bf 2

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bf 1

bg 1

8

E O

2a 2d

1a 2

1a 1

0a 1

0a 1

0a 1

0a 0

0a 0

0a 0

0a 0

0a 0

0a 0

0a 0

0c 0

9

E O

0d 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

0 0

10

E O

2d 2

1a 2

1a 2

0a 1

0a 1

0a 1

0d 0

0d 0

0d 0

0d 0

0d 0

0d 0

0d 0

0 0

E = Erythema; O = Oedema
a   Localised necrosis (assessment of erythema not impaired)
b   Necrosis over majority of treatment site (assessment of erythema precluded)
c   Localised spots and/or scabbing
d   Spots and/or scabbing over the majority of the treatment site
e   Blanching over majority of treatment site
f    Cracking of the skin at edge of blanched area
g   Wet ulceration on dose site

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). LD50: > 2000 mg/kg bw. No classification and labelling with respect to acute dermal toxicity is required according to Regulation 1272/2008/EC (CLP).

Executive summary:

Materials and methods

A single dose of 2000 mg of KMPS triple salt/kg bw was topically applied under occlusive conditions onto the clipped dorsal skin of 5 male and 5 female Sprague Dawley (CD) rats for a period of 24 hours. Animals were regularly observed for clinical signs of toxicity, mortality/viability and local reactions. Body weights were recorded on day 1, 8 and 15, respectively. Following a 24 hour exposure period, the test material was removed and animals observed for another 14 days. Thereafter, animals were necropsied and examined macroscopically.

 

Results and discussion

No deaths and no clinical signs of systemic toxicity were reported following administration of a single dermal dose of 2000 mg KMPS triple salt/kg bw to 5 male and 5 female Sprague Dawley (CD) rats. Severe dermal irritation was seen in three animals following removal of the dressings persisting until study termination. Slight to well‑defined dermal irritation was observed in six animals following removal dressings. These reactions had resolved completely by Day 3 in one animal, Day  5 in one animal and Day 8 in four animals. In addition, localised necrosis, localised spots and/or scabbing, spots and/or scabbing over the majority of the treatment site, blanching over the majority of the treatment site, cracking of the skin at the edge of the blanched area and wet ulceration on the dose site were noted in a number of animals during the study. Loss of body weight was recorded for one female and low body weight gains were recorded for two females on day 8. Macroscopic examination revealed a necrotic area on the dose site of three animals and scabbing on the dose site of two animals. No abnormalities were recorded for the remaining animals.