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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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A reliable GPMT was available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
EC Number:
260-906-9
EC Name:
Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
Cas Number:
57693-14-8
Molecular formula:
C40H20CrN6O14S2.3Na
IUPAC Name:
trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-)
Test material form:
solid: particulate/powder

In vivo test system

Test animals

Species:
guinea pig
Strain:
Himalayan
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: BRl, Biological Research laboratories ltd. Wölferstrasse 4, 4414 Füllinsdorf/Switzerland
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation: 336 - 391 9
- Housing: single
- Diet: ad lib.
- Water: ad lib.
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 24
- Humidity (%): 52 - 74
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
intradermal: 5 %
epidermal induction: 25 %
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25 %
Day(s)/duration:
day 22
No. of animals per dose:
Control: 5
Treated: 10
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1 intradermal, 1 epidermal
- Exposure period: 8 days
- Test groups: 10 animals
- Control group: 5 animals
- Site: scapular area
- Frequency of applications: 2 at a weeks distance

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22
- Exposure period: 24 h
- Site: flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 48
Challenge controls:
Opposite flank
Positive control substance(s):
not specified

Results and discussion

Positive control results:
No data.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
no
Remarks on result:
positive indication of skin sensitisation
Group:
positive control
Remarks on result:
other: no data

Any other information on results incl. tables

Test group skin response after challenge (25 % test substance in distilled water) after 24 and 48 h

 animal sex  erythema  edema   erythema    edema
 11 male  1 1 0
 12   male 1
13   male 2 3  0
 14   male 2  0
 15   male 3 2
 16   male 1
 17   male 2
 18   male
 19   male 2
 20   male 1 0

 

Applicant's summary and conclusion

Interpretation of results:
other: skin sensitising according to the CLP Regulation (EC 1272/2008)
Conclusions:
The test item cause skin reactions after challenge in all treated animals.
Executive summary:

Method

The allergenic potential of test substance was assessed in albino guinea pigs by the maximization-test of B. Magnusson and A.M. Kligman (1969), as per OECD guideline 406 .

Five males were used as control group and 10 males were used as test group.

The highest non-irritating test article concentration used for challenge application was 25% in bi-distilled water.

Results

All treated animals of the test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure; no reactions were seen in the negative control group.

Test material is judged skin sensitising.