Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
Buehler test

Test material

Constituent 1
Reference substance name:
Sodium Perborate Monohydrate
IUPAC Name:
Sodium Perborate Monohydrate
Details on test material:
-Physical state: White granules
-Analytical purity: no data
-Lot/batch No.: no data
-Storage condition of test material: At ambient room temperature and humidity

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
-Source: Ace Animals
-Weight at study initiation: Pre-test body weight range: 272-350 g for males and 289-344 g for females
-Housing: One per cage in suspended wire mesh cages
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled
-Humidity (%): controlled
-Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
No. of animals per dose:
10 (5 m / 5 f) per group
Details on study design:
Site preparation

Treated animals:
24 hours prior to each induction, the left flank of each animal was clipped free of hair. The area was approximately 5 x 5 cm. 24 hours after each induction dose, the same area was depilated. 24 hours prior to challenge, a new area on the right flank was clipped. 24 hours after the challenge, the right flank was depilated.

Controls:
During the induction phase of the study, one group of 5 male and 5 female animals served as an untreated control. 24 hours prior to challenge, a new area on the right flank was clipped. 24 hours after the challenge, the right flank was depilated.

Experimental design:
0.5 mL/animal of the test article was applied beneath gauze patches, to the prepared sites of ten test group animals. The sites were occluded. The guinea pigs were restrained for 6 hours after which time the patches were removed. This procedure was performed once every 7 days for a total of three 6 hour insults with the test article.

Screen:
Between the induction and challenge, a screen was conducted to determine the highest non-irritating concentration of the test article. One to four animals were used. 24 hours prior to dosing, the right flank of each animal was clipped. The appropriate concentrations were applied per animal. 24 hours after exposure, the right flank was depilated. The sites were scored for redness and oedema at 1, 24 and 48 hrs after exposure.

Challenge:
14 days after the last induction exposure, both the test article and control group animals were challenged at the highest non-irritating concentration as determined by the screen. All animals were challenged at a new site on the right flank in the same manner as the induction.

Type and frequency of observations:

Induction:
Test Article Group: The treated site of each animal was examined and scored for erythema and oedema at 1 h and 24 hrs after each induction exposure period.

Challenge:
Test Article and Control Groups: The treated sites of both the test article animals and the control group animals were scored for erythema and oedema at 24 and 48 hrs after challenge exposure.

All test article and control group animals were observed once daily during the study for mortality and toxicity. Body weights were recorded pre-test and at termination in the test article and control animals. Body weights were not recorded for screen animals.

Analysis of data:
Scores greater than the greatest score seen in the control group were considered positive. Based on the percent of animals exhibiting positive scores, the test article was classified as follows:
0 – 8 %: non-sensitizer
9 – 28 %: weak sensitizer
29 – 64 %: moderate sensitizer
65 – 100 %: potent sensitizer
Challenge controls:
Yes (see above)
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5 % solution
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
very slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5 % solution. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: very slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5 % solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5 % solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
very slight erythema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: very slight erythema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
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: 10.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
There was no indication for a sensitising potential of Sodium Perborate Monohydrate.
Executive summary:

In this test according to OECD Guideline 406, five healthy male and female Hartley albino guinea pigs were treated with Sodium Perborate Monohydrate three times over three weeks in an attempt to induce a sensitizing response. Another group of 5 male and 5 female albino guinea pigs were used as controls.

Two weeks after the last induction treatment the guinea pigs were challenged at the highest non-irritating concentration. The treated sites of the test article group were examined and scored for erythema and oedema at 1 and 24 hrs after each induction exposure period. The treated sites of the test article animals and the control group animals were scored for erythema and oedema at 24 and 48 hrs after the challenge exposure. Body weights were recorded pre-test and at termination in the test article and control animals. Scores greater than the highest score observed in the control group were considered positive.

Induction:

During the induction period, erythema was absent to moderate and oedema was absent to slight.

Challenge:

After the challenge of a 5 % dilution in distilled water, erythema responses in the test group were absent to very slight. Oedema was absent. In the control group, erythema was absent to very slight and oedema was absent.

Under the conditions of this study, the test article is a non-sensitizer.