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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:
19 Feb - 16 Apr 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(adopted 1981)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
2-Hydroxy-4,6-diphenyl-1,3,5-triazin
IUPAC Name:
2-Hydroxy-4,6-diphenyl-1,3,5-triazin
Details on test material:
Test article: FAT 92376/A
Additional specification: 2-Hydroxy-4,6-diphenyl-1,3,5-triazin
Batch No: 10.26
Analytical purity: 98%
Physical properties: white crystals
Storage conditions: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Pirbright White Strain (Tif: DHP) guinea pigs from CIBA-GEIGY Limited, Animal Production, 4332 Stein/Switzerland
- Age at study initiation: no data
- Weight at study initiation: 326 - 403 g
- Housing: single housing in Makrolon Type 3 cages
- Diet: standard guinea pig pellets (NAFAG No. 845, Gossau SG), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Photoperiod: 12 hrs dark / 12 hrs light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
Induction:
Intradermal:
5% FAT 92376/A in Oleum arachidis (w/v)
5% FAT 92376/A in the adjuvant/saline mixture (w/v)
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.4 g per patch

Challenge:
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.2 g per patch
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
Induction:
Intradermal:
5% FAT 92376/A in Oleum arachidis (w/v)
5% FAT 92376/A in the adjuvant/saline mixture (w/v)
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.4 g per patch

Challenge:
Epicutaneous:
50% FAT 92376/A in vaseline (w/w), 0.2 g per patch
No. of animals per dose:
Control: 5 animals per sex
Dose groups: 10 animals per sex
Details on study design:
RANGE FINDING TESTS:
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 92376/A have been examined on separate animals for the determination of the maximum subirritant concentration: 80% in vaseline was the highest applicable concentration of the test article. The tested concentrations did not induce erythema reactions, therefore a concentration of 50% (w/w) was chosen.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous, occlusive)

- Control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: Oleum arachidis
Injection 3: a 1:1 mixture (v/v) FCA/water
Epicutaneous: 50% in vaseline

- Tests groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/water
Injection 2: test substance in Oleum arachidis (w/v)
Injection 3: test substance in a 1:1 mixture (v/v) FCA/water
Epicutaneous: 50% in vaseline

- Site: into the neck region

- Frequency of applications: Every 7 days
- Duration: Days 0-9
- Concentrations:
Intradermal:
Test group: 5%
Epicutaneous:
Test group: 50% in vaseline (0.4 g paste per patch)


B. CHALLENGE EXPOSURE
- No. of exposures: 1(epicutaneous, occlusive)
- Day of challenge: 4 weeks after first induction
- Exposure period: 24 h
- Test groups:
Epicutaneous: 50% in vaseline

- Control group:
Epicutaneous: 50% in vaseline and vaseline alone

- Site: on the flank
- Concentrations: 0 and 50%
- Evaluation (hr after challenge): 24 and 48 h

OTHER:
The application site was pretreated with 10% sodium-laurylsulfate (open application) 24 hours prior to the epidermal induction application.
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
yes
Remarks:
potassium dichromate

Results and discussion

Positive control results:
No positive controls were included in this study. The reference values with potassiumdichromate were reported (experimental date Nov-Dec 1992).
Potassiumdichromate (Intradermal induction: Concentration of compound: 0-2%; Vehicle: physiological saline; Epidermal induction: Concentration of compound: 5%; Vehicle: vaseline; Epidermal challenge: Concentration of compound: 1%; Vehicle: vaseline) induced reactions in 9/10 animals, thus meeting the reliability criteria (>= 15% positive responders).

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no findings.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no findings
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no findings
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no findings.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information