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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1991-08-07 to 1999-06-19
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All test substances were concurrently tested in the same test persons including at least one known to have possess sensitizing properties (ammoniumsalt). The concentrations of test substances during induction and challenge phase were the same; therefore, it cannot be distinguished between irritant and sensitising effect.
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

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Aqueous solutions of the three test substances (1) Peroxydisulfuric acid diammonium salt, (2) Peroxydisulfuric acid disodium salt, (3) Peroxymonosulfuric acid, monopotassium salt, mixt. with potassium bisulfate, potassium sulfate and magnesium carbonate were tested for its irritating/sensitising properties on the back of the same test persons. The individuals received 4 applications lasting for 24 h in week 1, 2 and 3. The challenge applications were done on 4 days in week 5. The same concentrations of the test substances were used for induction and challenge phase. During week 4 no treatment occurred due to damage of grade 4 magnitude in a majority of subjects.
GLP compliance:
no

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:
(1) Peroxydisulfuric acid diammonium salt
(2) Peroxydisulfuric acid disodium salt
(3) Peroxymonosulfuric acid, monopotassium salt, mixt. with potassium bisulfate, potassium sulfate and magnesium carbonate

- Description:
(1) White solid
(2) White solid
(3) White crystal powder

- Lot/batch No.:
(1) D19335
(2) D40705
(3) not indicated

- Stability under test conditions: Not stated

- No pre-test on irritant effects was performed or reported

Method

Type of population:
general
Ethical approval:
not specified
Remarks:
The test persons were thoroughly informed about the purpose of the study.
Subjects:
The skin of 109 adult humans was used for this repeated insult patch test. All of the three substances indicated above were tested in parallel in the same individuals on different sites on the back.
Clinical history:
not indicated
Controls:
non-placebo controls
Route of administration:
dermal
Details on study design:
Induction schedule:
The patches were applied to the test persons for 24 h on 4 consecutive days in weeks 1, 2 and 3.
Way of Induction: Topical induction, occlusive conditions
Concentrations used for induction: See above (Details on test material)

Challenge schedule: The patches were applied to the test persons for 24 h on 4 consecutive days in week 5
Concentrations used for challenge: Same concentrations as used for the induction phase
Rechallenge: Yes (challenge application on 4 consecutive days, i.e. three daily re-challenges with an interval of 24 hours between each challenge application)

Scoring schedule: Scoring was performed after each patch removal and at the start of a new week

The test substance was removed 24 hours after topical application
No positive control was included

Examinations
Please refer to "Any other information on materials and methods incl. tables"

Results and discussion

Results of examinations:
During the induction phase the three test compounds induced skin reactions of grade 4 in 12 % (ammonium persulfate at 5000 ppm), 13 % (sodium persulfate at 5000 ppm) and 59 % (Impact at 7100 ppm) of the test persons, respectively.
The challenge applications at naïve sites induced skin reactions in 17, 16 and 42 % of the participiants following application of ammonium sulfate, sodium sulfate and Impact, respectively.

Applicant's summary and conclusion

Conclusions:
Based on the results and the limitations of this test, the test substances (Peroxydisulfuric acid diammonium salt; Peroxydisulfuric acid disodium salt; Peroxymonosulfuric acid, monopotassium salt, mixt. with potassium bisulfate, potassium sulfate and magnesium carbonate) cannot be classified as skin sensitisers.
Executive summary:

Materials and methods

Aqueous solutions of the three test substances (1) Peroxydisulfuric acid diammonium salt, (2) Peroxydisulfuric acid disodium salt, (3) Peroxymonosulfuric acid, monopotassium salt, mixt. with potassium bisulfate, potassium sulfate and magnesium carbonate were tested for its irritating/sensitising properties on the back of the same test persons. The individuals received 4 applications lasting for 24 h in week 1, 2 and 3. The challenge applications were done on 4 days in week 5. The same concentrations of the test substances were used for induction and challenge phase. During week 4 no treatment occurred due to damage of grade 4 magnitude in a majority of subjects.

Results and discussion

Distinct skin reactions were observed after induction and challenge phase in some individuals. However, from a scientific point of view the study has several limitations which distinctly influence the reliability and significance of the results:

- Sensitisation is an immune response to the application of a test substance and sensitisation could be observed at low, non-irritating concentrations.

- As the concentrations used for the induction and challenge phase were identical and shown to be irritating in many individuals, it is not possible to distinguish between an irritant and a sensitisation skin response.

- All test substances were concurrently tested in the same individuals; therefore, no conclusion can be drawn for the sensitising properties of the individual substances. Consequently, the results obtained in this study are not scientifically robust enough to derive any conclusions on the sensitising properties of either substance tested.