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EC number: 432-550-6 | CAS number: 243858-01-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
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- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
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- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
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- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From August 24, 1999 to September 24, 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- study was already available
Test material
- Reference substance name:
- -
- EC Number:
- 432-550-6
- EC Name:
- -
- Cas Number:
- 243858-01-7
- Molecular formula:
- Hill formula: C25H22FN7Na4O16S5 CAS formula: C25H26FN7O16S5.4Na
- IUPAC Name:
- tetrasodium 2-({4-fluoro-6-[methyl({2-[2-(sulfonatooxy)ethanesulfonyl]ethyl})amino]-1,3,5-triazin-2-yl}amino)-5-hydroxy-6-[2-(4-methyl-2-sulfonatophenyl)diazen-1-yl]naphthalene-1,7-disulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv Orange F97-0318
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Gartenstr. 27, 0-33178 Borchen, SPF breeding colony.
- Body weight at start of study: 312-420 g
- Housing: In fully air-conditioned rooms in 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
- Animal identification: Fur marking with KMn04 and cage numbering
- Randomization procedure: Randomization scheme 1999.0310
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: 50±20%
- Photoperiod: 12 h light/dark cycle
IN-LIFE DATES: From: To: August 24, 1999 to September 24, 1999
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- water
- Concentration / amount:
- 5% / 0.1 mL per injection
- 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 / 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 / 24 h
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- Test groups
The following test groups were used for the study:
Test group Number of animals
Determination of the primary non-irritant concentration 3
Determination of the tolerance of the intradermal injections 2
Control group 5
Treatment group 10
Test procedure
The following preparations were used for the intradermal injections:
Control group
1.) 50% Freund's Complete Adjuvant (i.e., FCA) emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed immediately before use with an equal volume of deionized water.
2.) Deionized water (i.e., vehicle)
3.) 50% Freund's Complete Adjuvant emulsion mixed with an equal volume of the vehicle
Treatment group
1.) 50% Freund's Complete Adjuvant emulsion
Original Freund's Complete Adjuvant (Sigma Chemical Company) was mixed immediately before use with an equal volume of deionized water.
2.) 5% test substance in deionized water
3.) 5% test substance in a 50% Freund's Complete Adjuvant emulsion
For the intradermal injections of the test substance in 50% Freund's adjuvant, test substance was dissolved in deionized water and then mixed with an equal volume of Freund's Original Adjuvant [percentages w/v].
For the dermal treatments, test substance was suspended in deionized water [percentages w/v].
Main test for the sensitizing properties
Chronological description of the test procedure indicating the day, at which procedure was carried out:
Study Day 0
The body weight of the animals was determined. The guinea pigs were shaved mechanically over a dorsal area of 4 x 6 cm in the vicinity of the shoulders.
Study Day 1
Intradermal induction treatment
Two intradermal injections per animal of the following preparations were applied. The injection sites were all within a dorsal area of 2 x 4 cm. The injection sites were left uncovered.
Treatment group:
Site Appl. vol. Conc Preparation
1 2 x 0.1 mL _ 50% Freund's Adjuvant
2 2 x 0.1 mL 5% Test substance in deionized water
3 2 x 0.1 mL 5% Test substance in 50% Freund's Adjuvant
Control group:
Site Appl. Vol. Preparation
1 2 x 0.1 mL 50% Freund's Adjuvant
2 2 x 0.1 mL Deionized water
3 2 x 0.1 mL Equal volume of deionized water and 50% Freund's Adjuvant
Study Day 2-7
The administration area was examined for local tolerance. Systemic toxic effects were recorded, when apparent.
Study Day 8
Dermal induction treatment
An amount of 0.5 mL of the test substance preparation (i.e., treatment group) or the vehicle (i.e., control group) was administered to a 2 x 4 cm cellulose patch. This patch covered the area where the intradermal injection had been placed. The administration area was then kept under an occlusive bandage covered with an impermeable film and an elastic bandage for 48 h.
Treatment group 25.0% test substance in deionized water
Control group Deionized water
Study Day 10
Occlusive bandage was removed, irritant effects were recorded, when apparent.
Study Day 11-21
No treatment of control or treatment group. Test animals were kept under observation.
Study Day 22
Dermal challenge treatment
One area of approximately 5 x 5 cm on the left flank was shaved mechanically. An amount of 0.5 mL of the test substance preparation was administered to a 2 x 2 cm cellulose patch. The administration area was then kept for 24 h under an occlusive bandage covered with an impermeable film and an elastic bandage.
Treatment and control group (left flank):
25.0% test substance in deionized water
Study Day 23
Occlusive bandage was removed. Any remnants of the test substance were carefully washed off with warm water.
Study Day 24
Examination of the skin approximately 24 h after removal of the patches.
Study Day 25
Examination of the skin approximately 48 h after removal of the patches. Body weight of the test animals was determined. - Positive control substance(s):
- yes
- Remarks:
- (alpha-hexyl cinnamic aldehyde tested in another study)
Results and discussion
- Positive control results:
- After the challenge treatment positive response was observed in 80% of the treated animals.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control
- Dose level:
- 25% dermal application
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Determination of the primary non-irritant concentration
No signs of irritation occurred after administration of the different test concentrations. Based on these results, a concentration of 25%test substance in deionized water was chosen for the challenge at Day 22.
Determination of the tolerance of the intradermal injections
-The intradermal injections with the 5.0% preparation caused well-defined erythema and edema as well as encrustions.
-The intradermal injections with the 1.0% and 0.2%preparation caused well-defined up to slight erythema and edema.
-Based on this preliminary test, a 5% preparation was selected for the intradermal injections in the main test.
Main test for the sensitizing properties
Body weight gains and clinical signs
-The body weight gains of the animals were not impaired.
-The treated animals showed no clinical signs of intoxication throughout the study.
Intradermal induction treatment
-The intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and edema as well as indurations and encrustations. The administration sites treated with the test substance in deionized water showed well-defined erythema and edema and encrustions. Intradermal injections of the vehicle alone exhibited no signs of irritation.
-Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not administered at Day 7.
Dermal induction treatment
-After the removal of the patches at Day 10, severe erythema and edema, indurated and encrusted skin as well as necrosis were observed at the sites previously treated with Freund's Adjuvant. The administration sites treated with the test substance showed well-defined erythema.
-The administration sites treated with the vehicle alone showed no signs of irritation.
Dermal challenge treatment
-No skin reactions were observed in the control and the treatment group 24 and 48 h after removal of the occlusive bandage.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance showed no evidence of sensitizing properties.
- Executive summary:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP.
Based on the results of a preliminary study, 5 and 25% of test substance in deionized water were selected as intradermal and dermal induction doses. The highest non-irritating concentration used for challenge application was 25% test substance in deionized water.
None of the animals of the test group showed skin reactions 24 and 48 h after removing the dressings. 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 study conditions, the test substance showed no evidence of sensitizing properties.
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