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main component 1 (isomer 1): 2-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonapht-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 1 (isomer 2): 2-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-3-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 2: 2,3-bis-{6-fluoro-4-[3-(2,5-disulfo-phenylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt;main component 3: 2,3-bis-{6-fluoro-4-[3-(1,5-disulfonaphth-2-ylazo)-4-hydroxy-2-sulfonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-propane sodium salt
EC number: 422-610-1 | CAS number: -
- 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
- Surface tension
- 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
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 October 1996 to 26 November 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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 (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Test material
- Reference substance name:
- -
- EC Number:
- 422-610-1
- EC Name:
- -
- Molecular formula:
- multi constituent
- IUPAC Name:
- tetracosasodium 2-[(1E)-2-[6-({4-[(1-{[4-({6-[(1E)-2-(2,5-disulfonatophenyl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propan-2-yl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]benzene-1,4-disulfonate 2-[(1E)-2-[6-({4-[(2-{[4-({6-[(1E)-2-(2,5-disulfonatophenyl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propyl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]naphthalene-1,5-disulfonate 3-[(1E)-2-[6-({4-[(1-{[4-({6-[(1E)-2-(4,8-disulfonatonaphthalen-2-yl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propan-2-yl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]naphthalene-1,5-disulfonate 5-[(1E)-2-[6-({4-[(2-{[4-({6-[(1E)-2-(2,5-disulfonatophenyl)diazen-1-yl]-5-hydroxy-7-sulfonatonaphthalen-2-yl}amino)-6-fluoro-1,3,5-triazin-2-yl]amino}propyl)amino]-6-fluoro-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonatonaphthalen-2-yl]diazen-1-yl]naphthalene-1,6-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): FAT 40'557/A
- Lot/batch No.: PV 1
- Purity: Approx. 65%
- Expiry date: 30 September 2002
- Stability of Test Article: Stable under storage condition.
- Stability of Test Article Dilution: Stable in polyethylene glycol, saline and FCA for at least 48 hours.
- Storage: In original container at room temperature away from light.
Constituent 1
- Specific details on test material used for the study:
- Identity: FAT 40557/A
Batch-no.: PV1
Purity: 65 %
Appearance: Solid powder, red-brown
Stability of Test Article: Stable under storage condition; expiration date: 30-SEP-2002
Stability of Test Article Dilution: Stable in polyethylene glycol, saline and FCA for at least 48 hours
Expiration date: 30 September, 2002
Storage conditions: In the original container at room temperature away from direct sunlight.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Füllinsdorf / Switzerland
- Age at delivery: 5-7 weeks
- Weight at delivery: Control and test group: 291 - 416 g, Pretest: 354-431 g
- Housing: Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
- Diet: Pelleted standard Nafag Ecosan 845 25W4, batch nos. 90/96 and 105/96 guinea pig breeding/ maintenance diet ("Nafag", Nähr- und Futtermittel AG, CH-9202 Gossau), ad libitum.
- Water: Community tap water from Itingen, ad libitum.
- Acclimation period: One week for the control and test group under test conditions after health examination. No acclimatization for the animals of the pre-test.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40-70 (values above 70 % during cleaning process possible)
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 5 %; 0.1 ml/site (Three pairs of intradermal injections)
- Day(s)/duration:
- Day 1
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 400
- Concentration / amount:
- 50 %; 0.3 ml
- Day(s)/duration:
- Day 8
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Concentration / amount:
- 50 %; 2 x 2 cm) of filter paper
- Day(s)/duration:
- Day 22
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Ten females were treated with the vehicle alone and twenty females were treated with the test article.
- Details on study design:
- RANGE FINDING TESTS:
- Intradermal injections: Two pairs of intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline was made simultaneously into the shaved neck of two guinea pigs. One week later intradermal injections (0.1 mL/site) were made into the clipped flank of the same guinea pigs at concentrations of 5 %, 3 % and 1 % of the test article in polyethylene glycol 400. The resulting dermal reactions were assessed 24 hours later. For intradermal induction application in the main study a 5 % test article dilution was selected.
- Epidermal applications: Two pairs of intradermal injections (0.1 mL/site) of a 1:1 (v/v) mixture of Freund's Complete Adjuvant/physiological saline was made simultaneously into the shaved neck of four guinea pigs. One week later both flanks of each of the guinea pigs were clipped and shaved just prior to the application. Thereafter 4 patches of filter paper ( 2 x 2 cm) were saturated with the test article at 50 % (this concentration used was found to be the most qualified to assure an optimum technical application procedure), 25 %, 15 % and 10 % in polyethylene glycol 400 and applied to the clipped and shaved flanks. The volume of test article concentration applied was approximately 0.2 mL. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours. 21 hours after removal of the dressing the application site was depilated with an approved depilatory cream (VEET Cream, Reckitt & Colman AG, CH-4123 Allschwil) to clean the application site from staining produced by the test article, so that possible erythema reactions were clearly visible at that time. The depilatory cream was placed on the patch sites and surrounding areas, and left on for 3-5 minutes. It was then thoroughly washed off with a stream of warm, running water. The animals were then dried with a disposable towel, and returned to their cages. The reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema on a numerical basis according to Draize.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal injections: An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 mL/site) were made at the border of a 4 x 6 cm area in the clipped region as follows: 1) 1:1 (v/v) mixture of Freund's Complete Adjuvant and physiological saline. 2) The test article, diluted with polyethylene glycol 400. 3) The test article diluted to 5% by emulsion in a 1:1 mixture of Freund's complete adjuvant and physiological saline.
Epidermal applications: On test day 7 and approximately 22 hours prior to the epidermal application the scapular area (approximately 6 x 8 cm) of the animals of the control and test group was clipped, shaved free of hair and the test area was pre-treated with a 10 % dilution of Sodium-Lauryl-Sulfate (SLS) in paraffinum per liquidum as no primary irritation had been observed in the pre-test. The SLS was massaged into the skin with a glass rod without bandaging. This 10 % concentration of SLS enhances sensitization by provoking a mild inflammatory reaction. On test day 8, a 2 x 4 cm patch of filter paper was saturated with the test article (50 % in polyethylene glycol 400) and placed over the injection sites of the test animals. The volume of test article concentration applied was approximately 0.3 mL. The patch was covered with aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for 48 hours. The epidermal application procedure described ensured intensive contact of the test article. The guinea pigs of the control group were treated as described above with polyethylene glycol 400 only. Reaction sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing, using the numerical grading system according to Draize.
B CHALLENGE
The test and control guinea pigs were challenged two weeks after the epidermal induction application. The test and control guinea pigs were treated in the same way. Hair was clipped and shaved from a 5 x 5 cm area on the left and right flank of each guinea pig just prior to the application. Two patches ( 2 x 2 cm) of filter paper were saturated with the highest non-irritating concentration of 50 % (left flank) and the vehicle only (polyethylene glycol 400 applied to the right flank) using the same method as for the epidermal application. The dressings were left in place for 24 hours. Approximately 21 hours after removal of the dressing the test sites treated with the test article were depilated with an approved depilatory cream (VEET Cream, Reckitt & Colman AG, CH-4123 Allschwil). The cream was placed on the patch sites for 3-5 minutes and then washed off with a stream of warm running water. When the application sites were clean and any stains from the test article removed the animals were dried with a disposable paper towel and returned to their cages. Approximately 24 and 48 hours after the removal of the dressing the application sites were assessed for erythema and oedema using the numerical scoring system according to Draize. - Challenge controls:
- The control animals were treated in the same way as described above without the test substance.
- Positive control substance(s):
- yes
- Remarks:
- The positive controls were performed with 2-Mercaptobenzothiazole (RCC project 901080) from 30 April 1996 to 07 June 1996 and Alphahexylcinnamaldehyde (RCC project 901203) from 14 May 1996 to 21 June 1996.
Results and discussion
- Positive control results:
- Clear positive results were observed in treated animals after the epidermal challenge application of 2-Mercaptobenzothiazole (RCC project 901080) from 30 April 1996 to 07 June 1996 and Alphahexylcinnamaldehyde (RCC project 901203) from 14 May 1996 to 21 June 1996.
65 % (at 24-hour reading) and 60 % (at 48-hour reading) of the animals of the test group were observed with positive skin reactions after treatment with a non-irritant test article concentration of 15 % in PEG 400.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: One animal of the test group (no. 353) was found dead on test day 23
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Remarks on result:
- other: One animal of the test group (no. 353) was found dead on test day 23
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15 %
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- other: ALPHA-HEXYLCINNAMALDEHYDE
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15 %
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Clinical observations:
- Erythema
- Remarks on result:
- other: ALPHA-HEXYLCINNAMALDEHYDE
Any other information on results incl. tables
SKIN EFFECTS AFTER INTRADERMAL INDUCTION:
A normal development of the local symptoms was observed in the animals of the control and test group after the intradermal injections.
SKIN EFFECTS AFTER EPIDERMAL INDUCTION:
No erythematous or oedematous reaction was observed in the animals treated with polyethylene glycol 400 only. As the test article at 50% in polyethylene glycol 400 stained the skin orange, it was not possible to determine whether erythema was present or not. However, no oedema was observed.
SKIN EFFECTS AFTER THE CHALLENGE APPLICATION:
No positive reactions were observed in the animals neither when treated with polyethylene glycol 400 alone nor when treated with the test article at 50% in polyethylene glycol 400. An orange discoloration was noted directly after removal of the patch. To remove discoloration all animals were depilated approximately 3 hours prior to challenge reading.
MORTALITY / VIABILITY:
One animal of the test group (no. 353) was found dead on test day 23. In the lungs several dark red foci (D=3 mm) were noted. The death was considered to be treatment unrelated since no clinical signs or deaths were observed in any other animals.
CLINICAL SIGNS (SYSTEMIC):
No systemic symptoms were observed in the animals.
BODY WEIGHTS:
The body weight of the animals was within the range of physiological variability known for this strain and age.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40557/A is not a considered as skin sensitizer in GPMT.
- Executive summary:
In a GLP-compliant sensitivity study using the Maximization-Test, performed according to OECD guideline 406, guinea pigs were treated with the test substance. Twenty animals were treated with the test substance and ten animals with only the vehicle (polyethylene glycol 400). The concentrations of the test substance used in the main study were determined by the results of the preliminary study. The intradermal induction of sensitization in the test group was performed using 5 % of the test substance in both the vehicle and adjuvant/vehicle mixture. One week later this was boosted by the topical application of the test substance at 50 % concentration over the injection sites. Animals of the control group were treated in the same manner but only the selected vehicle was used. Two weeks after the second induction all animals were challenged by topical application of the test substance at 50 % concentration. No animals reacted positive after the challenge with 50 % of the test substance. One animal of the test group was found dead on test day 23, but the death was considered to be treatment unrelated since no clinical signs or deaths were observed in any other animal. Based on the study results, FAT 40557/A is not a considered as skin sensitizer in GPMT.
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