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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-10-22 and 1992-01-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to OECD guideline and EU method, GLP-conform

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)
Version / remarks:
1981
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Version / remarks:
1984
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Chemical structure
Reference substance name:
[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt
EC Number:
811-773-6
Cas Number:
1713250-52-2
Molecular formula:
C32 H14 N6 O17 S4. xNa. xNH4
IUPAC Name:
[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Himalayan spotted
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: Control and test group (393 - 502 g), Pretest (402-473 g)
- Housing: Individually in Makrolon type-3 cages (size: 27 x 42 x 15 cm) with standard softwood bedding ("Lignocel")
- Diet: Pelleted standard Kliba 342 (ad libitum)
- Water: tap water (ad libitum); once weekly additional supply of ascorbic acid (1 g/L via the drinking water)
- Acclimation period: one week under test conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: physiol. saline (intradermal injection), vaselinum album (epidermal application)
Concentration / amount:
- Intradermal injection: 5% in physiol. saline
- Epidermal application: 25% in vaselinum album
- Challenge, epidermal: 25% in vaselinum album
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: physiol. saline (intradermal injection), vaselinum album (epidermal application)
Concentration / amount:
- Intradermal injection: 5% in physiol. saline
- Epidermal application: 25% in vaselinum album
- Challenge, epidermal: 25% in vaselinum album
No. of animals per dose:
control group: 10
test group: 20
Details on study design:
RANGE FINDING TESTS:
Two females were used for the intracutaneous pretest and 4 females for the epicutaneous pretest.
A. Intradermal injections
- 5, 3 and 1% of the test article in physiol. saline
- site: flank
- dermal reactions were assessed 24 hours later

B. Epidermal applications
- 25, 15, 10 and 5% of the test article in vaselinum album
- site: flank
- exposure period: 24 hours
- examination was performed 24 and 48 hours after removal of the dressing

MAIN STUDY
A.1. INDUCTION EXPOSURE (intradermal); day 0
- No. of exposures: three pairs of intradermal injections (0.1 mL/site) were made
- Test groups: Freund's complete adjuvant 50:50 with physiol. saline, 5% test article in physiol. saline, 5% test article in a mixture of Freund's complete adjuvant and physiol. saline (50:50)
- Control group: Freund's complete adjuvant 50:50 with physiol. saline, physiol. saline, Freund's complete adjuvant 50:50 with physiol. saline
- Site: area of dorsal skin from the scapular region
- Frequency of applications: single injection

A.2. INDUCTION EXPOSURE (epidermal); day 8
- Test group: 25% of the test article in vaselinum album
- Control group: vaselinum album only
- Site: the injection sites of the test animals
- Duration: 48 hours

B. CHALLENGE EXPOSURE; two weeks after the epidermal induction application (day 22)
- No. of exposures: 1
- Exposure period: 24 hours
- Test groups: left flank: 25% test substance in vaselinum album, right flank: vaselinum album only
- Control group: treated in the same way as described at the test group
- Site: flank
- Evaluation (hr after challenge): 24 and 48


Challenge controls:
yes
Positive control substance(s):
yes
Remarks:
formaldehyde

Results and discussion

Positive control results:
8 of 10 animals showed skin reactions after 24 h and 48 h after removing the dressings.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0.

Any other information on results incl. tables

Viability/Mortality: No death were occurred during the study.

Clinical signs, local:

Control group

Application area around the injection sites was found to show erythema and oedema from day 2 to 7; additionally around two of three injection sites necroses were observed from day 8 to 20; encrustation from day 19 to 21 and exfoliation from day 21 to 25 (termination of test). In addition staining was observed in the challenge application area from day 23 to 25.

Test group

Application area around one of the injection sites was found to show erythema and oedema from day 2 to 7. Application area around the other two injection sites showed oedema and staining from day 2 to 7. For the 3 injection sites necroses were observed from day 8 to 20; encrustation from day 19 to 21 and exfoliation from day 21 to 25. In addition epidermal induction and challenge application area showed staining from day 10 to 25 and 23 to 25 respectively.

On day 9 of test no observation could be performed because the animals were bandaged semi-occlusively.

Clinical signs, systemic

No systemic symptoms were observed in the animals.

Body weights

Two out of 10 control animals, 4 out of 20 test animals and the both animals of the intradermal pretest lost weight during the acclimatization period. The body weight gain of the other animals was not affected during the entire study.

Applicant's summary and conclusion