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Diss Factsheets

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:
1994
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)
Version / remarks:
adopted 17.7.1992
Deviations:
not specified
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Information not available.

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
EC Number:
233-311-7
EC Name:
Disodium 2,2'-(azodi-p-phenylene)bis[6-methylbenzothiazole-7-sulphonate]
Cas Number:
10114-47-3
Molecular formula:
C28H20N4O6S4.2Na
IUPAC Name:
disodium 2,2'-(diazene-1,2-diyldi-4,1-phenylene)bis(6-methyl-1,3-benzothiazole-7-sulfonate)
Test material form:
solid: particulate/powder
Details on test material:
- Appearance: orange powder- Batch No.: 31/94- Prevailing particle size: 2 - 4 µm

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Anlab, Prag, Czech Republic- Females (if applicable) nulliparous and non-pregnant: yes- Microbiological status of animals, when known: without parasites, microorganisms, viruses and fungi- Weight at study initiation: 300 - 366 g- Housing: T4 cages (5 animals per cage)- Diet (e.g. ad libitum): granulated commercially produced feed mixture- Water (e.g. ad libitum): drinking water with addition of ascorbic acid (20 mg/animal/day)- Acclimation period: 1 week

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1 % w/w Reactive Orange 13
Day(s)/duration:
day 0
Adequacy of induction:
not specified
Route:
intradermal
Vehicle:
other: Freund's Complete Adjuvant
Concentration / amount:
1 % w/w Reactive Orange 13
Day(s)/duration:
day 0
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
25 % w/w Reactive Orange 13
Day(s)/duration:
day 7
Adequacy of induction:
not specified
Challengeopen allclose all
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
1 % w/w Reactive Orange 13
Day(s)/duration:
day 20
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
1 % w/w Reactive Orange 13
Day(s)/duration:
day 27
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Treated group: 20 animalsControl group: 10 animals
Details on study design:
MAIN STUDY A. INDUCTION EXPOSURE - No. of exposures: 2 (intradermal and epicutaneous) - Test groups: 1 (20 animals) - Control group: 1 (10 animals) - Site: nape - Concentrations: 1 % (intradermal exp.), 25 % (epicutaneous exp.) B. CHALLENGE EXPOSURE - No. of exposures: 2 - Day(s) of challenge: day 20 and 27 - Test groups: 1 (20 animals) - Control group: 1 (10 animals) - Site: nape - Concentrations: 1 % - Evaluation (hr after challenge): 1, 24, 48 and 72 hours after application
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Hours after challenge:
1
Group:
test chemical
Dose level:
1 % w/w Reactive Orange 13
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin or any clinical reaction
Remarks on result:
no indication of skin sensitisation
Key result
Hours after challenge:
24
Group:
test chemical
Dose level:
1 % w/w Reactive Orange 13
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin or any clinical reaction
Remarks on result:
no indication of skin sensitisation
Key result
Hours after challenge:
48
Group:
test chemical
Dose level:
1 % w/w Reactive Orange 13
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin or any clinical reaction
Remarks on result:
no indication of skin sensitisation
Key result
Hours after challenge:
72
Group:
test chemical
Dose level:
1 % w/w Reactive Orange 13
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no skin or any clinical reaction
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to results of Guinea Pig Maximisation Test, the test substance, Reactive Orange 13, need not be classified as skin sensitiser, pursuant to Regulation (EC) No. 1272/2008.