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EC number: 281-866-9 | CAS number: 84045-65-8
- 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:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted May 12, 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Directive 84/449
- Deviations:
- no
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- This study was carried out in 1990.
Test material
- Reference substance name:
- Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate
- Cas Number:
- 84045-65-8
- Molecular formula:
- C31H21Na3ClN7O10S3
- IUPAC Name:
- Trisodium 5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfonatonaphthalen-2-yl)diazenyl]naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Identification: FAT 40'147/F
Description: red, solid
Batch Number: Op. 1/1990
Stability of test article: expiration date: March 1992
Stability of test article dilutions: stable for at least 48 hours in the solvents used
Storage Conditions: in the original container, protected from light, at approximately +20°C
Safety precautions: Gloves, goggles and face mask were sufficient to assure personnel health and safety.
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI; SPF-quality guinea pigs (synonym: Himalayan spotted)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Source: BRL, Biological Research Laboratories Ltd., Wölferstrasse 4, CH-4414 Fullinsdorf
Total Number of Animals per Test: 15 males, 15 females
Age at Acclimatization Start: males : 7 weeks, females: 8 weeks
Body Weight at Acclimatization Start: males: 304 - 384 g, females: 337 - 404 g
Identification: By unique cage number and corresponding ear tags.
Randomization: Randomly selected at time of delivery.
Acclimatization: One week under test conditions after veterinary examination.
The animals were distributed as follows: 5 males, 5 females for the control group and 10 males, 10 females for the test group.
Standard Laboratory Conditions:
Air-conditioned with 10-15 air changes per hour and hourly monitored environment with temperature 22 ± 3 °C, relative humidity 40-70 %, 12 hours artificial fluorescent light/12 hours dark, music during the light period.
Accommodation:
Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz).
Diet
Pelleted standard Kliba 342, Batch 57/90 guinea pig breeding/ maintenance diet ("Kuba", Klingentalmühle AG, CH-4303 Kaiseraugst), ad libitum. Results of analysis for contaminants are included in this report.
Water
Community tap water from Itingen, ad libitum. Once weekly additional supply of ascorbic acid via the drinking water.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other:
- Concentration / amount:
- 5 % test item in Freund's complete adjuvant and physiological saline (1:1) / 0.1 ml
- Day(s)/duration:
- Week 1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: petrolatum-oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- Week 2
- Adequacy of induction:
- non-irritant substance, but skin pre-treated with 10% SDS
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: petrolatum-oil
- Concentration / amount:
- 25 %
- Day(s)/duration:
- Week 4
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- The test was performed on 10 male and 10 female guinea pigs in the test group and 5 males and 5 females in the control group, respectively,
- Details on study design:
- RANGE FINDING TESTS:
The following concentrations of FAT 40138/D have been examined on separate animals for the determination of the maximum subirritant concentration: 1, 5, 10, 20, 30, and 50% in vaseline.
Erythema reactions were observed with 20, 30, and 50 % FAT 40138/D in vaseline.
MAIN STUDY
A. INDUCTION EXPOSURE - INTRADERMAL
- No. of exposures: 1
- Exposure period: Intradermal injection
- Test groups: 1
- Control group: 1
- Site: shaved neck
- Frequency of applications: once
- Duration: -
- Concentrations: 5 %
A. INDUCTION EXPOSURE - EPIDERMAL
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: 1
- Control group: 1
- Site: neck
- Frequency of applications: once
- Duration: 48 hours
- Concentrations: 25 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Week 4
- Exposure period: 24 hours
- Test groups: 1
- Control group: 1
- Site: flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 - Positive control substance(s):
- yes
- Remarks:
- solution of formaldehyde
Results and discussion
- Positive control results:
- 1) In the study with FORMALDEHYDLOESUNG (HCHO) 70 % of the animals were positive at 24 hours after treatment.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 20
Any other information on results incl. tables
TEST GROUP:
No positive reactions were evident after the first challenge application, neither when treated with the vehicle alone nor when treated with the test article diluted to 25 % in petrolatum-oil.
MORTALITY / VIABILITY:
One died spontaneously on day 22 of test.
SYMPTOMS, SYSTEMIC:
No systemic symptoms were observed during the study.
BODY WEIGHTS:
The body weight gain of the animals was not affected adversely during the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40147/F is not a skin sensitiser.
- Executive summary:
The sensitisation potential of the test substance was evaluated in a study conducted according to the maximisation test described in OECD Guideline 406 and EU Method B.6, in compliance with GLP. Five males and 5 females were used in the control group and 10 males and 10 females were used in the test group. Intradermal and epidermal inductions were carried out in week 1 and week 2 at 5 and 25 % test concentrations, respectively. The test and control guinea-pigs were challenged in week 4 with the epidermal application. The test concentration used for challenge was 25 %. 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. None of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, FAT 40147/F is not a skin sensitiser.
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