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Diss Factsheets
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EC number: 807-350-0 | CAS number: 1161009-88-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 31, 2016 - March 28, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- Council Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No. 1907/2006 of the European Parliament and the council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 5-bromo-9,9'-spirobi[fluorene]
- EC Number:
- 807-350-0
- Cas Number:
- 1161009-88-6
- Molecular formula:
- C₂₅H₁₅Br
- IUPAC Name:
- 5-bromo-9,9'-spirobi[fluorene]
Constituent 1
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test item preparation was prepared directly before administration. Appropriate amounts of the test item were moistened sufficiently with the vehicle and grounded in a mortar using a pestle. The test item preparation was administered within less than 1 hour after preparation. The stability of the test item in the vehicle was not investigated.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld, Germany
- Age at study initiation: 9 weeks (males), 12 weeks (females)
- Weight at study initiation: The mean initial body weight at the start of study was 226 g (range from 199 to 265 g).
- Fasting period before study: no
- Housing: separately in type III Makrolon cages with a shelter, placed on mobile racks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 – 23.1°C
- Humidity (%): 40.9 – 59.7%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 h
IN-LIFE DATES: From: day 1 To: day 15
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- paraffin oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 39 cm2
- % coverage: approx. 10%
- Type of wrap if used: self-adhesive fabric (Fixomull stretch, Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50, 200, 1000 and 2000 mg/kg bw
- For solids, paste formed: yes
VEHICLE
Designation: Art. 1.07174
Synonym: Liquid paraffin
Supplier: Merck KGaA, Germany
Batch: K45409474
Released until: April 30, 2019 - Duration of exposure:
- 24 h
- Doses:
- 50, 200, 1000 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 50 mg/kg bw: 5 (f)
200 mg/kg bw: 5 (f)
1000 mg/kg bw: 5 (f)
2000 mg/kg bw: 5 (m) / 5 (f) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Standard statistical methods have been applied for data processing.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the course of this study.
- Clinical signs:
- other: No clinical signs of toxicity were observed.
- Gross pathology:
- Gross pathological examination revealed no organ alterations in all animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item has no acute dermal toxic potential under the conditions of the present study, and the LD50 value exceeds 2000 mg/kg body weight after single dermal administration in rats.
- Executive summary:
Objective
The objective of the present study was to identify potential toxic effects of the test item, after single dermal administration to rats in a stepwise procedure.
Study Design
Groups of 5 female rats each were dermally treated with the test item for 24 hours at dose levels of 50, 200, 1000 and 2000 mg/kg bw. The study was started with the lowest dose level of 50 mg/kg bw. As no mortalities were observed up to the highest dose, a further group of 5 male rats was exposed at a dose level of 2000 mg/kg bw.
Mortality and clinical signs were monitored for at least 6 hours after administration and then daily. All animals were weighed before treatment (day 1) and on days 2, 4, 6, 8, 11, 13, and 15. At the end of the observation period, all surviving rats were sacrificed and subjected to a detailed necropsy.
Results
No mortality occurred during the course of this study.
No clinical signs of toxicity were observed.
One female rat treated with 2000 mg/kg bw showed a decrease of the body weight during the observation period. The body weight development of all other rats was inconspicuous throughout the study.
Gross pathological examination revealed no organ alterations in all animals.
Conclusion
The test item has no acute dermal toxic potential under the conditions of the present study, and the LD50 value exceeds 2000 mg/kg body weight after single dermal administration in rats.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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