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Diss Factsheets

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Current guideline, GLP, full report performed on the analogue substance

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:
At the time of testing LLNA was not available

Test material

Constituent 1
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
Test material form:
other: solid and liquid preparations

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 (e.g. ad libitum): ad lib.- Water (e.g. ad libitum): ad lib.- Acclimation period: 1 weekENVIRONMENTAL 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)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
intradermal: 5 %epidermal induction: 25 %epidermal challenge: 25 %
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
intradermal: 5 %epidermal induction: 25 %epidermal challenge: 25 %
No. of animals per dose:
Control: 5Treated: 10
Details on study design:
MAIN STUDYA. 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 distanceB. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: 22- Exposure period: 24 h- Site: flank- Concentrations: 25 %- Evaluation (hr after challenge): 24 & 48
Challenge controls:
Opposite flank
Positive control substance(s):
not specified

Results and discussion

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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
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:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.
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:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
other:
Group:
positive control
Remarks on result:
other: see remarks

Any other information on results incl. tables

Test Group Skin Response after challenge TEST ARTICLE-TREATED, 25% in distilled water

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

 

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The analogue substance was tested for skin sensitizing properties following OECD 406 (GMPT). Under the experimental conditions the substance is considered as strong skin sensitizer.
Executive summary:

To assess the allergenic potential of the analogue substance in albino guinea pigs the Maximization-Test of B. Magnusson and A.M. Kligman (1969) was used.

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.

All treated animals of the test group showed erythematous skin reactions 24 and 48 hours after epidermal challenge exposure and the test material is judged skin sensitising.