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EC number: 442-640-7 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-01-18 to 2002-03-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- -
- EC Number:
- 442-640-7
- EC Name:
- -
- Cas Number:
- 479541-17-8
- Molecular formula:
- Hill formula: C32H26CuFN9Na4O19S5
- IUPAC Name:
- Tetrasodium 2-(4-fluoro-6-(2-(2-sulfonatoethansulfonyl)ethyl amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(2-(2-hydroxy-5- sulfonatophenylazo)-4,5-dimethoxyphenylazo)-7-sulfonatonaphthalene-1-sulfonatocuprate(II)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Oliv F00-0149
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: M & B A/S P.O. box 1079 DK-8680 Ry Denmark
- Weight at study initiation: 3.4 kg
- Housing: In transparent macrolon® cages (type V) on soft wood granulate in an air-conditioned room, 5 animals per cage
- Diet (e.g. ad libitum): ssniff Ms-H (V 2233), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 hours light / dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: 50 % Freund´s Complete Adjuvant emulsion or deionized water
- Concentration / amount:
- Concentration of test material and vehicle used at induction: a) I. Intradermal: 5 % deionized water
b) II. Intradermal: 25 % deionized water
Concentration of test material and vehicle used for each challenge: 25 % deionized water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 50 % Freund´s Complete Adjuvant emulsion or deionized water
- Concentration / amount:
- Concentration of test material and vehicle used at induction: a) I. Intradermal: 5 % deionized water
b) II. Intradermal: 25 % deionized water
Concentration of test material and vehicle used for each challenge: 25 % deionized water
- No. of animals per dose:
- Determination of the tolerance of the intradermal injections: 2
Determination of the primary non-irritant concentration: 3
Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- RANGE FINDING TESTS:
DETERMINATION OF THE PRIMARY NON-IRRITATING CONCENTRATION
-3 animals each received 4 intradermal injections of a 50% Freund’s Complete Adjuvant emulsion into the dorsal area, since Freund’s Complete Adjuvant may lower the threshold of primary irritation. The test substance was then administered to the flanks of the guinea pigs. 0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch, which was fixed to the flank and covered occlusively for 24 hours with a bandage and film. 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
- 5%, 1%, or 0.2% was administered twice by intradermal injection to 2 guinea pigs. The injection sites were all within a dorsal area measuring 2 x 4 cm near the shoulders. 24, 48, 72 and 96 hours after administration the injection sites were examined for local tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two intradermal injections
- Test groups: 50 % Freund's Adjuvants, 5% substance in deionized water, or 5% substance in 50 % Freund's Adjuvants
- Control group: 50 % Freund's Adjuvants, deionized water, or equal volume of deionized water and 50 % Freund's Adjuvants
- Site: dorsal area of 2 x 4 cm
- Frequency of applications: two injections
- Duration: 7d
- Concentrations: 5% substance in deionized water or 5% substance in 50 % Freund's Adjuvants in test groups
A1: DERMAL INDUCTION TREATMENT
- No. of exposures: one 2 x 4 cm cellulose patch
- Day(s) of challenge: study day 8
- Test groups: 25 % test substance in deionized water
- Control group: deionized water
- Site: the patch covered the area where the intradermal injection had been placed
- Concentrations: 0.5mL containing 25 % test substance in deionized water
- Evaluation (hr after challenge): bandage was removed on study day 10 and animals were observed study days 11-21
B. CHALLENGE EXPOSURE
- No. of exposures: one 2 x 2 cm cellulose patch
- Day(s) of challenge: study day 22
- Exposure period: 24h
- Test groups: 25 % Reaktiv Oliv F00-0149 in deionized water
- Control group: 25 % Reaktiv Oliv F00-0149 in deionized water
- Site: One area of approx. 5 x 5 cm on the left flank
- Concentrations: 0.5mL containing 25 % Reaktiv Oliv F00-0149 in deionized water
- Evaluation (hr after challenge): 24 and 48h after removal of the patches - Challenge controls:
- The challenge control group received 25 % Reaktiv Oliv F00-0149 in deionized water on the left flank
- Positive control substance(s):
- no
Results and discussion
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
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this GLP guideline study accordign to OECD 406, the test item is not a dermal sensitizer.
- Executive summary:
In a dermal sensitization study with 25% Reactive Olive F00-0149 in 50 % Freund´s Complete Adjuvant emulsion or deionized water, 10 guinea pigs were tested using the method of the Magnusson and Kligman. 25% was the maximum concentration not causing irritating effects in preliminary test.
Intradermal induction of FCA (with and without test item) led to moderate edema and erythema, also to hardenings and incrustations. At dermal induction the parts treated with FCA before showed strong erythema and edema after 10 days. The parts of the skin that were just treated with testing substance in the vehicle showed no signs of an irritation.
There was no evidence of sensitisation of each challenge concentration in the treatment or control group.
Under conditions of this study, Reactive Olive F00-0149 is not a dermal sensitizer.
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