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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:
key study
Study period:
1991-04-03 - 1992-01-13
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The identity and purity of the test material was not specified in the study report. This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Cross-reference
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

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(peroxymonosulphate) bis(sulphate)
Details on test material:
- Name of test material (as cited in study report): Caroate
- Description: White powder
- Analytical purity: see section 1 of IUCLID
- Impurities (identity and concentrations): No known impurities
- Batch No./Date of Production: 05 02 90-1
- Stability under test conditions: According to the information from the sponsor the test substance was stable throughout the experimental period
- Storage condition of test material: closed container and refrigerator

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-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:
physiological saline
Concentration / amount:
Induction
- Intradermal: 0.05%
- Epicutaneous: 10%

Challenge
- Epicutaneous: 3%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Induction
- Intradermal: 0.05%
- Epicutaneous: 10%

Challenge
- Epicutaneous: 3%
No. of animals per dose:
Control group 1: 6 animals (identical treatment of animals of the test substance group)
Control group 2: 6 animals (as the result of the first challenge was unequivocal, a second challenge was not performed. The animals of the control group 2 were left untreated)
Treatment group: 10 animals
Details on study design:
not indicated
Challenge controls:
not indicated
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no systemic toxic effects
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no systemic toxic effects.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
3%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no systemic toxic effects
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 3%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no systemic toxic effects.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
none observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: none observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
6
Clinical observations:
none oberved
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: none oberved.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability). KMPS triple salt has no sensitizing properties on the skin of the guinea pig. No classification as sensitiser is necessary according to Regulation 1272/2008/EC (CLP) and Directive 67/548/EC (DSD).
Executive summary:

Materials and methods

KMPS triple salt was applied to the skin of guinea pigs to determine its sensitizing properties by the maximization test method. The test substance was dissolved in physiological saline solution 0.9%. The concentrations were 0.5% (intradermal) or 10% (epidermal) during induction and 3 % (epidermal) during challenge.

Results and discussion

Following epidermal challenge, none of the animals of the test substance group showed any findings at the treated skin sites.

None of the animals of the control group showed changes at the exposed skin areas. Systemic toxic effects could not be detected. The general condition and body development of the test animals were not affected.