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Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1985-02-13 - 1985-05-29
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was not performed according to GLP. The identity and purity of the test material was not specified in the study report. During the rechallenge a high incidence of skin reactions was observed in both control and test group animals after application of distilled water only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
no
Remarks:
, several quality assurance inspections were carried out.
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study as conducted before the LLNA became the standard method for testing skin sensitisation.

Test material

Constituent 1
Chemical structure
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

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
not indicated

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: distilled water
Concentration / amount:
Primary induction (intradermal): 1% w/v in distilled water and in Freunds Complete adjuvant, respectively
Secondary Induction (epicoutaneous): 0.6 ml 15% w/v KMPS triple salt in distilled water
First Challenge: 0.2 ml 6% w/v KMPS triple salt in distilled water
Second Challenge: 0.2 ml 3% w/v KMPS triple salt in distilled water

Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: distilled water
Concentration / amount:
Primary induction (intradermal): 1% w/v in distilled water and in Freunds Complete adjuvant, respectively
Secondary Induction (epicoutaneous): 0.6 ml 15% w/v KMPS triple salt in distilled water
First Challenge: 0.2 ml 6% w/v KMPS triple salt in distilled water
Second Challenge: 0.2 ml 3% w/v KMPS triple salt in distilled water

No. of animals per dose:
ten males, ten females,
controls: ten males, ten females
Details on study design:
not indicated
Challenge controls:
not indicated
Positive control substance(s):
not specified

Results and discussion

Positive control results:
not indicated

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Key result
Reading:
other: first challenge, 1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
6% w/v KMPS triple salt
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: first challenge, 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 6% w/v KMPS triple salt. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.
Key result
Reading:
other: first challenge, 2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
6% w/v KMPS triple salt
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: first challenge, 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 6% w/v KMPS triple salt. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.
Key result
Reading:
other: first challenge, 1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
6% w/v KMPS triple salt
No. with + reactions:
5
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: first challenge, 1st reading. . Hours after challenge: 24.0. Group: other: concurrent control. Dose level: 6% w/v KMPS triple salt. No with. + reactions: 5.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.
Key result
Reading:
other: first challenge, 2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
6% w/v KMPS triple salt
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: first challenge, 2nd reading. . Hours after challenge: 48.0. Group: other: concurrent control. Dose level: 6% w/v KMPS triple salt. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.
Key result
Reading:
other: first challenge, 1st and 2nd reading
Group:
test chemical
Dose level:
distilled water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: other: first challenge, 1st and 2nd reading. Group: other: test group. Dose level: distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
other: first challenge, 1st and 2nd reading
Group:
negative control
Dose level:
distilled water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: other: first challenge, 1st and 2nd reading. Group: other: concurrent control group. Dose level: distilled water. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
other: rechallenge, 1st and 2nd reading
Group:
test chemical
Dose level:
3% w/v KMPS triple salt
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: other: rechallenge, 1st and 2nd reading. Group: test group. Dose level: 3% w/v KMPS triple salt. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
other: rechallenge, 1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
3% w/v KMPS triple salt
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
only slight, patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: rechallenge, 1st reading. . Hours after challenge: 24.0. Group: other: concurrent control. Dose level: 3% w/v KMPS triple salt. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: only slight, patchy erythema.
Key result
Reading:
other: rechallenge, 2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
3% w/v KMPS triple salt
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: other: rechallenge, 2nd reading. . Hours after challenge: 48.0. Group: other: concurrent control. Dose level: 3% w/v KMPS triple salt. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
Key result
Reading:
other: rechallenge: 1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
distilled water
No. with + reactions:
9
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: Reading: other: rechallenge: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: distilled water. No with. + reactions: 9.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.
Key result
Reading:
other: rechallenge: 2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
distilled water
No. with + reactions:
1
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: Reading: other: rechallenge: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: distilled water. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.
Key result
Reading:
other: rechallenge, 1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
distilled water
No. with + reactions:
3
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: rechallenge, 1st reading. . Hours after challenge: 24.0. Group: other: concurrent control. Dose level: distilled water. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.
Key result
Reading:
other: rechallenge, 2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
distilled water
No. with + reactions:
2
Total no. in group:
20
Clinical observations:
only slight or moderate patchy erythema
Remarks on result:
other: see Remark
Remarks:
Reading: other: rechallenge, 2nd reading. . Hours after challenge: 48.0. Group: other: concurrent control. Dose level: distilled water. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: only slight or moderate patchy erythema.

Any other information on results incl. tables

Primary irritation screen

Intradermal injection

Administration of 100% w/v KMPS triple salt in Freunds Complete Adjuvant proved to be impossible by injection into the dermis. Sites of intradermal injection of formulations incorporating 3% w/V KMPS triple salt in distilled water or Freunds Complete Adjuvant showed dermal changes including loss of elasticity or eschar formation which were considered to reflect substantial damage of the treated tissue. Reactions to intradermal injection of 1% w/v KMPS triple salt in either vehicle were blanching, slight or moderate erythema and or discolouration.

Occluded topical application (first phase)

Occluded topical application of 20%, 30% and 40% w/v KMPS triple salt in distilled water caused discolouration and reduced dermal pliability or eschar formation and yet treatment with 10% w/v KMPS triple salt in distilled water failed to elicit any dermal change other than pitting of the surface on one of the test sites.

Occluded topical application (second phase)

There were no irritation responses or dermal changes at the sites of occluded topical application of 3% or 6% w/v KMPS triple salt in distilled water. Formulations incorporating 12% or 20% w/v KMPS triple salt in distilled water elicit slight or moderate erythema and, in some cases, discolouration of the treated skin.

Induction

Intradermal injection

Administration of 1% w/v KMPS triple salt in distilled water or the adjuvant or of the vehicles alone or in combination, caused dermal changes such as discolouration and irritation reactions not exceeding slight erythema.

Occluded topical application

Three control males showed slight, confluent or moderate, patchy erythema 4 hours after removal of occlusive dressings which had applied distilled water to their dorsum. Contemporaenous treatment of test group animals with 15% w/v KMPS triple salt in distiled water elicited similar erythematous responses from eight guinea-pigs, but coagulated blood from injection sites disturbed during the occlusion procedure had partially obscured the dermal test sites of more than one-half of he test group animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The incidence of significant erythematous reations to challenge with 3% w/v KMPS triple salt in distilled water was not greater among animals previously subjected to induction procedures involving repeated administration of the test material than among animals of a comtemporaneous control group.
Under the conditions of this study, it was concluded that repeated administration of KMPS triple salt has failed to cause delayed contact hypersensitivity in guinea-pigs.
Executive summary:

Materials and methods


The potential of KMPS triple salt to cause delayed contact hypersinsitivity in guinea-pigs was assessed by the Magnusson-Kligman Maximisation Test.


 


The shaven dorsum of ten male and ten female Dunkin-Hartley guinea-pigs were subjected to intradermal injections of Freunds Complete Adjuvant, 1% w/v KMPS triple salt in distilled water and 1% w/v KMPS triple salt in the adjuvant on Day 1. Seven days later the same area of skin was treated by topical application of 15% w/v KMPS triple salt in distilled water and the test site was covered by an occlusive dressing for48 hours. the same induction procedures were carried out on a contemporaneous control group, except that the test material was replaced by vehicle in all doses.


On day 22 all animals were challenged by occluded application of distilled water to the left flank and 6% w/v KMPS triple salt in distilled water to the right flank. The occlusive dressings were removed on the following day and the condition of the test sites was assessed approximately 24 and 48 hours later.


The result obtained at first challenge was tested by repeating the procedure on Day 29. On this occasion the vehicle was applied to a naive site on the right flank and 3% w/v KMPS triple salt in distilled water was applied to the left flank.


 


Results and discussion


First challenge application of distilled water failed to elicit any erythematous responses.


Contemporaneous treatment of the opposite flank with 6% w/v KMPS triple salt in distilled water caused slight or moderate patchy erythema in five controls and nine test group animals examined 24hours after challenge and in single test and control group animals examined 48 hours after challenge.


The test sites subjected to the second challenge with the vehicle showed slight or moderate patchy erythema in three control and nine test group animals at the first examination and in two control and one test animal at the second examination.


Slight, patchy erythema affected a single control male 24 hours after second challenge application of 3% w/v KMPS triple salt in distilled water in the first reading and disappeared in the 2nd reading.