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EC number: 276-634-9 | CAS number: 72391-23-2
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1995
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:
- 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:
- Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate
- EC Number:
- 276-634-9
- EC Name:
- Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate
- Cas Number:
- 72391-23-2
- Molecular formula:
- C36H36ClN3O7S.Na
- IUPAC Name:
- sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate
- Test material form:
- other: solid
- Details on test material:
- - Name of test material : FAT 21016/C
- Analytical purity: 96 %
- Lot/batch No.: 400047.32
- Storage condition of test material: Room temperature
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 400047.32
- Expiration date of the lot/batch: December, 1998
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: between 317 to 408 g
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet : standard guinea pig pellets - NAFAG No. 845, Gossau SG, ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Oleum arachidis
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 0
- Adequacy of induction:
- highest technically applicable concentration used
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Remarks:
- Vaseline
- Concentration / amount:
- 50 %
- 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:
- petrolatum
- Remarks:
- (vaseline)
- Concentration / amount:
- 5 %
- Day(s)/duration:
- Day 21
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test Group: 10/sex
Control group:
10 animals of same sex - Details on study design:
- RANGE FINDING TESTS:
Intradermal Induction:
The concentration for the intradermal injections was selected on account of the solubility of the test article in standard vehicles and its local and systemic tolerability in a pretest. The following concentration of test article has been used for intradermal injection:
5 % in Oleum arachidis (w/v).
Since 5 % FAT 21016/C in Oleum arachidis could be injected and was well tolerated, this concentration was used for the intradermal induction.
Epidermal Applications (induction and challenge)
The concentrations for the epidermal applications were selected on account of the primary irritation potential of the test article. The following concentrations of FAT 21016/C have been examined on separate animals for the determination of the maximum subirritant concentration (see also Table 4):
1, 5, 10, 20, 30, and 50 % in vaseline.
50 % was the highest possible concentration of the test article in vaseline.
Reactions were observed with 10, 20, 30, and 50 % FAT 21016/C in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE
DAY 0: INDUCTION, intradermal injections:
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the left and right side of the shaved neck of the test and control group animals.
Test group:
- adjuvant/saline mixture 1:1 (v/v)
- 5 % FAT 21016/C in Oleum arachidis (w/v)
- 5 % FAT 21016/C in the adjuvant/saline mixture (w/v)
Control group:
- adjuvant/saline mixture 1:1 (v/v)
- adjuvant/saline mixture 1:1 (v/v)
- Oleum arachidis
DAY 8: INDUCTION, epidermal application
In the test group FAT 21016/C was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g per patch; occluded administration for 48 hours).
The control group was treated with the vehicle only.
Test group:
- 50 % FAT 21016/C in vaseline
Control group:
- vaseline only
B. CHALLENGE EXPOSURE
- Exposure period: 24 hrs
- Test groups: The test group animals were tested on one flank with FAT 21016/C in vaseline (w/w) and on the other flank with the vehicle alone
- Control group: The control group animals were tested on one flank with FAT 21016/C in vaseline (w/w) and on the other flank with the vehicle alone
- Site: flank
- Concentrations: 0.2 g per patch
- Evaluation (hr after challenge): 24 h - Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
Results and discussion
- Positive control results:
- Positive control groups showed weak sensitisation potential
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- intradermal induction: 5 %; epidermal induction: 50 % and challenge: 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- intradermal induction: 5 %; epidermal induction: 50 % and challenge: 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- intradermal induction: 0 %; epidermal induction: 0 % and challenge: 5 % FAT 21016/C and vehicle on separate flanks
- 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:
- negative control
- Dose level:
- intradermal induction: 0 %; epidermal induction: 0 % and challenge: 5 % FAT 21016/C and vehicle on separate flanks
- 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:
- positive control
- Dose level:
- intradermal induction: 5 %; epidermal induction: 50 % and challenge: 30 %
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- intradermal induction: 5 %; epidermal induction: 50 % and challenge: 30 %
- No. with + reactions:
- 13
- Total no. in group:
- 20
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
Induction reactions:
After removal of the dressing on day 10, irritation of the epidermal application site was observed in 20/20 test group animals.
Challenge reactions:
Twenty four and forty eight hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. The challenge reactions showed 0 score for erythma and edema.
General
The body weight was recorded at start and end of the test. Body weights were not affected by treatment.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21016/C did not show skin sensitising potential in albino guinea pigs.
- Executive summary:
Evaluation of the skin sensitisation potential of FAT 21016/C was performed in the albino guinea-pigs according to OECD TG 406 (GPMT method) and EU Method B. 6, using maximisation technique. Based on the results of the pre-test, the test group was exposed to following concentrations during the different phases of the study: intradermal induction: 5 % in Oleum arachidis, epidermal induction: 50 % in vaseline and challenge: 5 % in vaseline on one flank and vaseline only on the other flank. None of the animals of the test group showed skin reactions 24 and 48 hours after challenge exposure. Hence it was concluded that, FAT 21016/C did not show skin sensitising (contact allergenic) potential in albino guinea pigs.
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