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Diss Factsheets

Administrative data

Description of key information

A skin sensitisation test was performed according to OECD 406 following GLP guidelines. The test substance does not have skin sensitising properties.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
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
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.
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
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
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
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.
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

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

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. 

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a dermal sensitization study with Reactive Navy FC 63805 in deionized water or in 50% Freund's Adjuvant, 10 female Pirbright-White guinea pigs were tested using the guinea pig maximization test. No animals had reactions to the test substance. Therefore, Reactive Navy FC 63805 is not considered a dermal sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In a dermal sensitization study according to OECD 406, none of ten animals of the treatment group showed a positive skin response after the challenge procedure. Thus, the test item is not considered a dermal sensitizer. No classification applies.