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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:
1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study predates availability of the LLNA method.

Test material

Constituent 1
Reference substance name:
-
EC Number:
431-830-5
EC Name:
-
Molecular formula:
C28H18F2N8Na4O16S5
IUPAC Name:
reaction mass of: tetrasodium 4-amino-6-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate tetrasodium 4-amino-6-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): Reaktiv Marineblau FC 63805

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Remarks:
Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HARLAN WINKELMANN Gartenstr. 27 D-33178 Borchen SPF breeding colony
- Weight at study initiation: mean=381g
- Housing: fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): ssniff Ms-H (V2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 7d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 degrees C
- Humidity (%): 50± 20%
- Photoperiod (hrs dark / hrs light): 12 hrs lighting time daily

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
5% / 4*0.1 mL
Day(s)/duration:
Day 1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25 % / 0.5 mL
Day(s)/duration:
Day 8 for 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
25% / 0.5 mL
Day(s)/duration:
Day 22 for 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Test Groups:
- Number of animals in test group: 10
- Number of animals in negative control group: 5
- Number of animals to determine the primary non-irritant concentration: 3
- Number of animals to determine the tolerance of the intradermal injections: 2

10 animals in the treatment group and 5 animals in the control group were used. In case of a questionable result additional animals will be tested to give a total of 20 test and 10 control animals.
Details on study design:
RANGE FINDING TESTS:
- Determination of the primary non-irritant concentration:
Prior to the determination of the primary non-irritation concentration in a dermal occlusive test the animals received 4 intradermal injections of a 50% Freund's
Complete Adjuvant emulsion (4 x 0.1 ml) into the dorsal area. Two guinea pigs then received either 25%, 5%, or 1% test substance in dionized water. Flank hair was mechanically removed and 0.5 ml of the test substance preparation was administered to a 2 x 2 cm cellulose patch covered occlusive for 24 hours. 24 hours after removal of the patches, the treated skin areas were examined for erythema and edema.
- Determination of the tolerance of the intradermal injections:
To determine the tolerance of intradermal injections, 5%, 1%, or 0.2% of the test substance was administered twice by intradermal injection to 2 guinea pigs. 24, 48, 72 and 96 hours after administration the injection sites were examined for local tolerance.


MAIN STUDY
A1. INTRADERMAL INDUCTION EXPOSURE
- No. of exposures: 2 intradermal injections per animal
- Test groups: 5% test substance in dionized water or in 50% Freund's Adjuvant
- Control group: 50% Freund's Adjuvant
- Site: within a dorsal area of 2 x 4 cm
- Concentrations: 5% test substance
A2. DERMAL INDUCTION EXPOSURE
- Exposure period: 48 h
- Test groups: 25.0 % test substance in deionized water
- Control group: deionized water
- Site: The cellulose patch including the test substance covered the area where the intradermal injection had been placed
- Concentrations: 25.0 % test substance

B. CHALLENGE EXPOSURE
- Exposure period: 24h
- Test groups: 25.0 % test substance
- Site: One area of approx. 5 x 5 cm on the left flank, shaved mechanically
- Concentrations: 25.0 % test substance
- Evaluation (hr after challenge): 24h
Positive control substance(s):
yes
Remarks:
benzocaine

Results and discussion

Positive control results:
Testing for sensitizing properties of Benzocain was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN.
Intradermal induction was performed using 1.0 % Benzocain in sesame oil. Dermal induction and challenge treatment were carried out with 25.0 % Benzocain in sesame oil.
Based on the results of this study Benzocain may cause sensitization by skin contact.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
25 %
No. with + reactions:
2
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
24
Group:
positive control
Dose level:
25 %
No. with + reactions:
5
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Reading:
rechallenge
Hours after challenge:
48
Group:
positive control
Dose level:
25 %
No. with + reactions:
4
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

Maximum concentration not causing irritating effects in preliminary test: 25 % 

Signs of irritation during induction:

The intradermal inductions of FCA (with and without test substance) lead to moderate edema and erythema, and further to callus and incrustations. During the dermal induction the areas pre-treated with FCA showed severe erythema and edema after 10 days. The skin areas treated only with the test substance showed no signs of irritation.

Evidence of sensitisation of each challenge concentration:

Treated group:0/10 
Control group:0/5

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Reactive Navy FC63805 is not a dermal sensitizer based on results from a guinea pig maximization test.
Executive summary:

In a dermal sensitization study with Reactive Navy FC63805 in dionized water or in 50% Freund's Adjuvant, 10 female Pirbright-White guinea pigs were tested using the guinea pig maximization test (GPMT). Under the conditions of the present study, none of ten animals of the treatment group showed a positive skin response after the challenge procedure.

Maximum concentration not causing irritating effects in preliminary test: 25 % 

Signs of irritation during induction:

The intradermal inductions of FCA (with and without test substance) lead to moderate edema and erythema, and further to callus and incrustations. During the dermal induction the areas pre-treated with FCA showed severe erythema and edema after 10 days. The skin areas treated only with the test substance showed no signs of irritation.

Evidence of sensitisation of each challenge concentration:

Treated group:0/10 
Control group:0/5

Under conditions of these study, Reactive Navy FC63805 is not a dermal sensitizer.