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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was carried out in accordance with the Health Effects Test Guideline of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 33-39 (August 1982) and following the conditions of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Health Effects Test Guideline of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 33-39 (August 1982)
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was done in the USA and was reported in 1990. The study was not done for REACH purposes.

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
EC Number:
239-707-6
EC Name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
Cas Number:
15630-89-4
Molecular formula:
CH2O3.3/2H2O2.2Na
IUPAC Name:
disodium carbonate, compound with hydrogen peroxide (2:3)
Details on test material:
- Name of test material (as cited in study report): FB (TM) sodium percarbonate SO 2544
- Physical state: white granules
- Purity test date: The sponsor assumes responsibility for purity and stability determinations (including under test conditions)
- Lot/batch No.: I2439101
- Storage condition of test material: at room temperature
- Other:

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hra:(DH)SPF
Sex:
male/female
Details on test animals and environmental conditions:
Twenty-four acclimated male and female albino guinea pigs weighing from 420 to 550 g were used for this study. They were divided equally by sex into three groups consisting of a test group of 10 animals, a naive control group of 10 animals, and a positive control group of four animals. The animals were individually housed in screen-bottom cages in a temperature- and humidity-controlled room (67-79 °C, 31-65 % humidity), and provided continuous access to certified Guinea Pig Chow 5026, Purina Mills, Inc., and water.

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
75% w/v mixture for induction
25% w/v mixture for challenge
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
75% w/v mixture for induction
25% w/v mixture for challenge
No. of animals per dose:
10 per dose, 10 per naive control, 4 per positive control
Details on study design:
The test material was applied to one area on each animal by placing 0.4 mL of a 75 % w/v mixture of test material and deionised water on an adhesive pad and placing the pad on the test site along the anterior left flank. The patch was covered with rubber dam and overwrapped with Elastoplast tape. The dressing remained in place for a period of 6 hours after which it was removed. The test sites were wiped with a wet disposable paper towel. The positive control material was administered as 0.4 mL dose in the same manner as for the test group. Due to the strong irritation present in the test site of the positive control animals, a third induction dose for these animals was applied to a test site slightly posterior to the initial site. The animals received one aplication per week for 3 weeks. The naive control animals were not treated during this phase of the study.
Challenge controls:
Two weeks following the administration of the third induction dose, a challenge dose of the 25 % w/v mixture of the test material in deionised water was administered along the anterior right flank of the test group animals in the same manner as during the induction phase. At this time the 10 naive control animals were also treated with a challenge application of the test material in the same manner as for the test group. The positive control material was administered as a 0.4 mL dose at a concentration of 0.1 % w/v in acetone. The method used for the positive control group was the same as that of the test group.
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: first and second
Hours after challenge:
48
Group:
test chemical
Dose level:
75 % in deionised water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
all test animals appeared normal throughout the study
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
test chemical
Dose level:
25 % in deionised water
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
all animals appeared normal throughout the study
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 25 % in deionised water. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: all animals appeared normal throughout the study.
Reading:
other: first and second
Hours after challenge:
48
Group:
negative control
Dose level:
none
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
one naive control animal was found dead on day 3 of the study. The gross necropsy revealed no visible lesions
Remarks on result:
other: see Remark
Remarks:
Reading: other: first and second. . Hours after challenge: 48.0. Group: negative control. Dose level: none. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: one naive control animal was found dead on day 3 of the study. The gross necropsy revealed no visible lesions.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
25 % in deionised water
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
all animaly appeared normal throughout the study
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 % in deionised water. No with. + reactions: 0.0. Total no. in groups: 9.0. Clinical observations: all animaly appeared normal throughout the study.
Reading:
other: first and second
Hours after challenge:
48
Group:
positive control
Dose level:
0.3 % DNCB in 80' % ethanol/deionised water
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
all animals appeared normal throughout the study
Remarks on result:
other: see Remark
Remarks:
Reading: other: first and second. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.3 % DNCB in 80' % ethanol/deionised water. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: all animals appeared normal throughout the study.
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
0.1 % w/v of DNCB in acetone
No. with + reactions:
4
Total no. in group:
4
Clinical observations:
all animals appeared normal throughout the study
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1 % w/v of DNCB in acetone. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: all animals appeared normal throughout the study.

Any other information on results incl. tables

Very faint to faint dermal reactions were elicited from all ten test animals during the induction phase. None of the test or naive control animals reacted to the challenge application of the test material.

All four animals in the positive control group reacted during the induction and challenge phases of the study. The positive control animals were considered to be sensitised because of the strong reactions they exhibited to the 0.1 % w/v concentration of DNCB in acetone. Historical data produced at the performing laboratory had indicated that a 0.1 % w/v concentration of DNCB in acetone would produce no irritation or very slight irritation in previously untreated animals when treated in the same manner as for the challenging application.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Based upon the results obtained, sodium percarbonate is not considered to be a skin sensitiser in guinea pigs.
Executive summary:

The skin sensitisation potential of sodium percarbonate was tested in male and female guinea pigs according to the Health Effects Test Guideline of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 33-39 (August 1982) and following the conditions of GLP.

Very faint to faint dermal reactions were elicited from all ten test animals during the induction phase. None of the test or naive control animals reacted to the challenge application of the test material.

All four animals in the positive control group reacted during the induction and challenge phases of the study. The positive control animals were considered to be sensitised because of the strong reactions they exhibited to the 0.1 % w/v concentration of DNCB in acetone.

Based upon the results obtained, sodium percarbonate is not considered to be a skin sensitizer in guinea pigs.

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