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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
Study period:
1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A valid guinea pig maximization study is available.

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[4-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonamide, reaction products with aqueous organic chromium(III) complex sodium salt, then laked with acidified C10-14-tert-alkyl(linear and branched) amines
EC Number:
939-383-2
Molecular formula:
UVCB substance
IUPAC Name:
3-[4-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonamide, reaction products with aqueous organic chromium(III) complex sodium salt, then laked with acidified C10-14-tert-alkyl(linear and branched) amines
Test material form:
solid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- lot/batch No.of test material: Misch.PA1+3/91
- Expiration date of the lot/batch: January 1997

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, Stein, Switzerland
- Age at study initiation:
- Weight at study initiation: 321 to 408 g.
- Housing: 1 animals per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2 °C
- Humidity: 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1992-12-14 To: 1993-01-14

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Remarks:
20%
Concentration / amount:
5%
Route:
epicutaneous, semiocclusive
Vehicle:
other: vaseline
Concentration / amount:
50 %
Day(s)/duration:
48 h for 4 Weeks
Challenge
Route:
epicutaneous, semiocclusive
Vehicle:
other: vaseline
Concentration / amount:
30% and 50%
Day(s)/duration:
Two weeks after epidermal application/ 24 h
No. of animals per dose:
20 (test item)
10 (control)
Details on study design:
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Exposure period: 48h (epidermal eposure)
- Test groups: yes
- Control group: yes
- Site: neck
- Frequency of applications: once per week
- Duration: 4 weeks
- Concentrations: see above

During weeks 3 and 4 no treatments were performed.

B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: 1
- Exposure period: 24h
- Test groups: yes
- Control group: yes
- Site: flank
- Concentrations: 20%
- Evaluation (hr after challenge): 24 and 48h

OTHER:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- test article in 20 % propylene glycol in water (w/v)
- test article in the adjuvant/saline mixture (w/v)
Challenge controls:
vehicle (vaseline)
Positive control substance(s):
yes
Remarks:
Potassium dichromate

Results and discussion

Positive control results:
A sensitization rate of 90% was observed in the experimental animals after the challenge with 1% (w/w) potassium dichromate in vaseline.

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
19
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
20%
No. with + reactions:
0
Total no. in group:
19
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10

Any other information on results incl. tables

On experimental day 17 female guinea pig No. 53 was found dead. Macro pathological investigation did not reveal any changes. Since no clinical signs were observed in all other treated guinea pigs and with respect to the low incidence of this finding, no toxicological relevance is attributed to this death.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met