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Reaction mass of copper complex of [(2,6-difluoroheterocycl-4-yl)amino]hydroxy{[2-hydroxy-3-sulfonato-5-(vinylsulfonyl)phenyl]diazenyl}naphthalene sulfonic acid, dialkali salt and copper complex of [(2,6-difluoroheterocycl-4-yl)amino]-hydroxy{[2-hydroxy-3-sulfonato-5-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl]diazenyl}naphthalene sulfonic acid, trialkali salt
EC number: 479-550-2 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 October 2002 to 14 January 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in accordance with EC B.6 method, OECD 406 and US EPA OPPTs 870.2600 methods in accordance with GLP
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study has been conducted when the LLNA was not yet the standard method.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: M & B A/s, PO Box 1079, DK-8680 Ry Denmark
- Weight at study initiation: 355 g. Minimum 324g, maximum 404g
- Housing: Macrolon cages (type 4) on soft wood granulate in groups of 5 animals
- Diet: ssniff Ms-H (V2233), ad libitum
- Water: Tap water in plastic bottles, ad libitum
- Acclimation period: At least 7 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
IN-LIFE DATES: From: Oct. 29, 2002 To: Oct. 29, 2002 - Route:
- intradermal
- Vehicle:
- water
- Remarks:
- deionized
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 5 % test substance in deionized water mixed with Freunds complete adjuvant emulsion
b) dermal: 25 % in deionizes water
Concentration of test material and vehicle used for each challenge:
25 % in deionized water - Concentration / amount:
- Concentration of test material and vehicle used at induction:
a) intradermal: 5 % test substance in deionized water mixed with Freunds complete adjuvant emulsion
b) dermal: 25 % in deionizes water
Concentration of test material and vehicle used for each challenge:
25 % in deionized water - No. of animals per dose:
- Determination of tolerance of the intradermal injections: 2
Determination of the primary non iritating 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-irritant concentration:
The following test concentrations were administered to the left and right flanks of three guinea pigs respectively:
Animal 1: 25.0 % in deionized water (left flank), 5% in deionzed water (right flank)
Animal 2: 25.0 % in deionized water (left flank), 1% in deionzed water (right flank)
Animal 3: 5.0 % in deionized water (left flank), 1% in deionzed water (right flank)
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 h with a bandage and film. 24 h after removal of the patches, the treated skin areas were examined for erythema and edema.
Determination of the tolerance of the intradermal injections:
The following preparations were administered twice by intradermal injection to 2 guinea pigs:
Site 1. 2X0.1 mL 5.0 % test substance in deionized water
Site 2. 2X0.1 mL 1.0 % test substance in deionized water
Site 3. 2X0.1 mL 0.2 % test substance in deionized water
24, 48, 72 and 96 h after administration the injection sites were examined for local tolerance.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal)
- No. of exposures: 2
- Exposure period: 1-7 d
- Test groups: Yes
- Control group: Yes, (50 % Freund's Adjuvant)
- Site: Dorsal area
- Frequency of applications: 2 in 7 d
- Duration: 7 d
- Concentrations: 5.0% in deionized water (site 2) and 5% in 50% Freunds adjuvants
INDUCTION EXPOSURE (Dermal)
- No. of exposures: 0.5 mL of the test substance preparation as cellulose patch
- Test groups: Yes, 25.0 % test substance in deionzed water
- Control group: Yes, deionized water
- Site: Dorsal area
- Frequency of applications: Single on Day 8
B. CHALLENGE EXPOSURE (Dermal)
- No. of exposures: One
- Day(s) of challenge: Day 22
- Exposure period: 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
- Test groups: 5.0 % test substance in deionized water
- Control group: 5% test substance in deionized water
- Site: Left flank
- Evaluation (hr after challenge): 24 and 48 h after removal of the patches
OTHER:
The substance is considered to be sensitizing if 30 % or more of the animals in the treatment group definitely showed a positive skin reaction and at the same time no irritant effects have emerged in the control group. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
- Positive control results:
- The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexylcinnamaldehyde for the maximization test.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- 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: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- 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: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 5 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- 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: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- 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: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, none of ten animals of the treatment group showed a positives skin response after the challenge procedure.
- Executive summary:
A study was conducted to assess the sensitizing potential of the test substance in female Pimol:DH Moellegaard guinea pigs, according EU Method B.6. and OECD guideline 406, using the Magnusson & Kligman method, in compliance with GLP.
Intradermal induction was performed using 5 % test substance in deionized water. Dermal induction was carried out with 25 % test substance in deionised water and the challenge test carried out with 5 % test substance in deionized water.
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexylcinnamic aldehyde for the maximization test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to assess the sensitizing potential of the test substance in female Pimol:DH Moellegaard guinea pigs, according to EU Method B.6. and OECD guideline 406, using the Magnusson & Kligman method, in compliance with GLP.
Intradermal induction was performed using 5 % test substance in deionized water. Dermal induction was carried out with 25 % test substance in deionised water and the challenge test carried out with 5 % test substance in deionized water.
The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the maximization test.
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
Migrated from Short description of key information:
A study was performed to determine the skin sensitizing potential of the test substance in guinea pigs according to EU method B.6 and OECD 406 guideline using the Magnusson & Kligman method in compliance with GLP. The test showed no evidence for sensitizing properties in guinea pigs
Justification for selection of skin sensitisation endpoint:
GLP guideline study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test substance showed no evidence for sensitizing properties in guinea pigs in an appropriate GLP guideline study.
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