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EC number: 471-980-9 | CAS number: 1016986-95-0
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study test phase 2005-09-12 to 2005-09-27. Report completed and signed off 2005-12-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets criteria for classification as reliable without restriction according to Klimisch et al (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- -
- EC Number:
- 471-980-9
- EC Name:
- -
- Cas Number:
- 1016986-95-0
- Molecular formula:
- Hill formula: C42 H24 Lim N9 Nan O15 S6 m+n=5 3=
- IUPAC Name:
- 7-{2-[2-(2-{5-cyano-4-methyl-2,6-bis[(4-sulfophenyl)amino]pyridin-3-yl}diazen-1-yl)-4-(naphthalen-2-yl)-1,3-thiazol-5-yl]diazen-1-yl}naphthalene-1,3,5-trisulfonic acid trilithium hydride disodium hydride
- Details on test material:
- Identification: FSM-003B (S196439)
Description: black powder
Batch number: CE-501-2
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- Female CBA/Ca (CBA/CaBkl) strain mice were supplied by B & K Universal Ltd, Hull, UK. On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals were in the weight range of 15 to 23 g, and were eight to twelve weeks old.
The animals were individually housed in suspended solid-floor polypropylene cages furnished with softwood woodflakes. Free access to mains tap water and food (Certified Rat and Mouse Diet (Code 5LF2) supplied by BCM IPS Limited, London, UK) was allowed throughout the study.
The temperature and relative humidity were controlled to remain within target ranges of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0, 5, 10 and 25% w/w
- No. of animals per dose:
- four per dose group
- Details on study design:
- Following a preliminary screening test groups of four mice were treated with the test material at concentrations of 5%, 10% or 25% w/w in dimethyl formamide. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 uI of the appropriate concentration of the test material to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette. A further group of four mice received the vehicle alone in the same manner.
Five days following the first topical application of the test material (Day 6) all mice were injected via the tail vein with 250ul of phosphate buffered saline (PBS) containing 3H-methyl thymidine giving a total of 20 uCi to each mouse. Five hours following the administartion of 3HTdR all mice were killed and the draining auricular lymph nodes from the mice were excised and pooled for each experimental group. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation. The pooled lymph node cells were pelleted and resuspended. To precipitate out the radioactive material the pellet was resuspended in Trichloroacetic acid (TCA). After approx. 18h incubation the precipitates were recovered by centrifugation and transferred to scintillation fluid. HTdR incorporation was measured by B-scintillation counting. Following a period of time in darkness, the number of radioactive disintegrations per minute was then measured. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- None used.
Results and discussion
- Positive control results:
- The positive control responded as expected and confirmed that the test system was operating as expected.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 5 % = 1.54 10% = 1.71 25% = 2.41
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Vehicle = 5670.65 5% = 8729.5 10% = 9678.43 25% = 13687.24
Any other information on results incl. tables
Clinical observations and Mortality Data
There were no deaths during this study. No signs of systemic toxicity were noted in the test or control animals during the test. Black staining of the fur and ears was noted one hour post dosing on Days 1, 2 and 3.
Bodyweight
Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test.
- Executive summary:
Introduction
This study was undertaken to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical administration to the dorsal surface of the ear. The method was designed to meet the requirements of the following guidelines:
OECD Guidelines for the Testing of Chemicals 429 'Skin Sensitisation: Local Lymph Node Assay' (adopted 24 April 2002)
Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Directive 2004/73/EC
Results and Conclusion
All three test concentrations (5% w/w, 10% w/w, 25% w/w) gave a negative result. The test material was considered to be a non-sensitiser under the conditions of the test.
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