Potassium perchlorate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 March - 21 July 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 21.4 ± 1.1g
- Housing: Disposable crystal polystyrene cages (22.00x8.5x8.0cms) containing autoclaved sawdust
- Diet: SSNIFF R/M-H pelleted maintenance diet batch no. 3016578 (SSNIFF Spezialdiaten GmbH, Soest, Germany)
- Water: Tap water (filtered using a 0.22 µm filter) ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 -70
- Air changes (per hr): 12 cycles/hr of non-recycled air
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr (7:00 - 19:00)


IN-LIFE DATES: From: 25 March 2008 To: 07 April 2008

Vehicle:

dimethylformamide

Concentration:

Vehicle (0% test item); 1%. 2.5%, 5%, 10%, 25%, HCA 25%

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: Due to the unsatisfactory solubility of the test item in the first recommended vehicle
(acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles.
A solution was obtained at the maximum concentration of 25%.
- Irritation: The test item was non-irritant in the preliminary test, whatever the concentration.
The highest concentration retained for the main test was therefore the maximal practicable
concentration (25%), according to the criteria specified in the International Guidelines.
- Lymph node proliferation response:


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine Local Lymph Node Assay (LLNA)

- Criteria used to consider a positive response:
% increase in ear thickness
between day 1 and day 3 or 6 Irritation level Interpretation
< 10% I Non-irritant
10 - 30% II Slightly irritant
> 30% III Irritant

TREATMENT PREPARATION AND ADMINISTRATION: On days 1, 2 and 3, a dose-volume of
25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears,
using an adjustable pipette fitted with a plastic tip. In order to avoid licking and to ensure an
optimized application of the test materials, the animals were placed under light isoflurane
anesthezia during the administration. No massage was performed but the tip was used to
spread the preparation over the application sites. No rinsing was performed between each application.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

no data

Positive control results:

In the positive control group given HCA at the concentration of 25%, a moderate increase in
cellularity and a stimulation index exceeding the threshold value of 3 (SI = 8.83) were noted.
The study was therefore considered valid.

Key result

Parameter:

SI

Remarks on result:

other: Test item 1% 1.59 Test item 2.5% 1.49 Test item 5% 1.71 Test item 10% 1.21 Test item 25% 0.54 HCA 25% 8.83

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: dpm per group: Vehicle 589.6 Test item 1% 935.26 Test item 2.5% 878.25 Test item 5% 1007.9 Test item 10% 715.00 Test item 25% 319.85 HCA 5205.31

Key result

Parameter:

SI

Value:

1.59

Test group / Remarks:

concentration of the test item: 1 %

Key result

Parameter:

SI

Value:

1.49

Test group / Remarks:

concentration of the test item: 2.5 %

Key result

Parameter:

SI

Value:

1.71

Test group / Remarks:

concentration of the test item: 5 %

Key result

Parameter:

SI

Value:

1.21

Test group / Remarks:

concentration of the test item: 10 %

Key result

Parameter:

SI

Value:

0.54

Test group / Remarks:

concentration of the test item: 25 %

Due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles. A solution was obtained at the maximum concentration of 25%. Consequently, the concentrations selected for the preliminary test were 2.5, 5, 10 and 25%. Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (25%). No mortality and no clinical signs were observed during the study. No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the treated groups.

Treatment	Concentration (%)	Irritation level	Stimulation index (SI)
Test item	1	non-irritant	1.59
Test item	2.5	non-irritant	1.49
Test item	5	non-irritant	1.71
Test item	10	non-irritant	1.21
Test item	25	non-irritant	0.54
HCA	25	-	8.83

Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.

Executive summary:

A GLP study was conducted at CIT Laboratories France to evaluate the potential of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA). Evaluation of local irritation was also carried out in parallel. Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay and is therefore considered as non sensitising.

Reference 2

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

25 March - 21 July 2008

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

In water, potassium perchlorate will rapidly dissolve and completely dissociate into the perchlorate anion and the corresponding cation. Toxicity is determined only by the perchlorate moiety of the salt. as potassium is known to be non-toxic. Based on that, read-across is possible to other perchlorate salt dissociating in water without any toxic cation.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across: supporting information

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 9-10 weeks
- Weight at study initiation: 21.4 ± 1.1g
- Housing: Disposable crystal polystyrene cages (22.00x8.5x8.0cms) containing autoclaved sawdust
- Diet: SSNIFF R/M-H pelleted maintenance diet batch no. 3016578 (SSNIFF Spezialdiaten GmbH, Soest, Germany)
- Water: Tap water (filtered using a 0.22 µm filter) ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 30 -70
- Air changes (per hr): 12 cycles/hr of non-recycled air
- Photoperiod (hrs dark / hrs light): 12 hr/12 hr (7:00 - 19:00)


IN-LIFE DATES: From: 25 March 2008 To: 07 April 2008

Vehicle:

dimethylformamide

Concentration:

Vehicle (0% test item); 1%. 2.5%, 5%, 10%, 25%, HCA 25%

No. of animals per dose:

4

Details on study design:

RANGE FINDING TESTS:
- Compound solubility: Due to the unsatisfactory solubility of the test item in the first recommended vehicle
(acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles.
A solution was obtained at the maximum concentration of 25%.
- Irritation: The test item was non-irritant in the preliminary test, whatever the concentration.
The highest concentration retained for the main test was therefore the maximal practicable
concentration (25%), according to the criteria specified in the International Guidelines.
- Lymph node proliferation response:


MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: murine Local Lymph Node Assay (LLNA)

- Criteria used to consider a positive response:
% increase in ear thickness
between day 1 and day 3 or 6 Irritation level Interpretation
< 10% I Non-irritant
10 - 30% II Slightly irritant
> 30% III Irritant

TREATMENT PREPARATION AND ADMINISTRATION: On days 1, 2 and 3, a dose-volume of
25 µL of the control or dosage form preparations was applied to the dorsal surface of both ears,
using an adjustable pipette fitted with a plastic tip. In order to avoid licking and to ensure an
optimized application of the test materials, the animals were placed under light isoflurane
anesthezia during the administration. No massage was performed but the tip was used to
spread the preparation over the application sites. No rinsing was performed between each application.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Statistics:

no data

Positive control results:

In the positive control group given HCA at the concentration of 25%, a moderate increase in
cellularity and a stimulation index exceeding the threshold value of 3 (SI = 8.83) were noted.
The study was therefore considered valid.

Key result

Parameter:

SI

Remarks on result:

other: Test item 1% 1.59 Test item 2.5% 1.49 Test item 5% 1.71 Test item 10% 1.21 Test item 25% 0.54 HCA 25% 8.83

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: dpm per group: Vehicle 589.6 Test item 1% 935.26 Test item 2.5% 878.25 Test item 5% 1007.9 Test item 10% 715.00 Test item 25% 319.85 HCA 5205.31

Key result

Parameter:

SI

Value:

1.59

Test group / Remarks:

concentration of the test item: 1 %

Key result

Parameter:

SI

Value:

1.49

Test group / Remarks:

concentration of the test item: 2.5 %

Key result

Parameter:

SI

Value:

1.71

Test group / Remarks:

concentration of the test item: 5 %

Key result

Parameter:

SI

Value:

1.21

Test group / Remarks:

concentration of the test item: 10 %

Key result

Parameter:

SI

Value:

0.54

Test group / Remarks:

concentration of the test item: 25 %

Due to the unsatisfactory solubility of the test item in the first recommended vehicle (acetone/olive oil (4/1, v/v)), dimethylformamide was chosen from the other proposed vehicles. A solution was obtained at the maximum concentration of 25%. Consequently, the concentrations selected for the preliminary test were 2.5, 5, 10 and 25%. Since the test item was non-irritant in the preliminary test, the highest concentration retained for the main test was the maximal practicable concentration (25%). No mortality and no clinical signs were observed during the study. No cutaneous reactions and no noteworthy increase in ear thickness were observed in the animals of the treated groups.

Treatment	Concentration (%)	Irritation level	Stimulation index (SI)
Test item	1	non-irritant	1.59
Test item	2.5	non-irritant	1.49
Test item	5	non-irritant	1.71
Test item	10	non-irritant	1.21
Test item	25	non-irritant	0.54
HCA	25	-	8.83

Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
Based on the read-across justification potassium perchlorate can be considered as not skin sensitisating.

Executive summary:

A GLP study was conducted at CIT Laboratories France to evaluate the potential of the test item ANHYDROUS SODIUM PERCHLORATE (batch No. lot moyen du 10/01/08 test) to induce delayed contact hypersensitivity using the murine Local Lymph Node Assay (LLNA). Evaluation of local irritation was also carried out in parallel. Under the experimental conditions of this study, the test item ANHYDROUS SODIUM PERCHLORATE did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay and is therefore considered as non sensitising.

Reference 3

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)