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EC number: 426-540-0 | CAS number: 2973-59-3
- 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:
- 1997-11-27 to 1998-01-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD 402 and EU Method B3 (Acute Toxicity Dermal) test without deviations.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- : from the Swiss GLP Monitoring Authorities
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 426-540-0
- EC Name:
- -
- Cas Number:
- 2973-59-3
- Molecular formula:
- C8 H7 Br O3
- IUPAC Name:
- 2-bromo-5-hydroxy-4-methoxybenzaldehyde
- Details on test material:
- - Name of test material (as cited in study report): T002019
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: no data
- Physical state: gray to brown powder
- Analytical purity: 91.3 % (HPLC)
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 00265786
- Expiration date of the lot/batch: 1998 July 01 (retest test)
- Stability under test conditions: Unknown, is excluded from the Statement of compliance
- Storage condition of test material: In the original container, at room temperature, aways from direct sunlight
- Other: no data
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Janssen Pharmaceutica N.V., 00265786
- Expiration date of the lot/batch: 01-JUL-1998 (retest date)
- Purity:91.3%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In original container at room temperature away from direct sunlight.
- Solubility and stability of the test substance in the solvent/vehicle: Unknown
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL., Biological Research Labolatories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks; females: 11 weeks.
- Weight at study initiation: Male: 243-2252 g; Females: 199-218 g.
- Fasting period before study: no data
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding ("Lignocel", Schill AG, CH-4132 Muttenz) during treatment and observation
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3433, batch no. 90/97 rat maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum. Results of analyses for contaminants are archived at RCC Ltd, Itingen.
- Water (e.g. ad libitum): Community tap water from Itingen, available ad libitum. Results of bacteriological, chemical and contaminant analyses are archived at RCC Ltd, Itingen.
- Acclimation period: 27-Nov-1997 to 03-Dec-1997
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3 deg C
- Humidity (%): 40-70 % (values above 70% possible during cleaning)
- Air changes (per hr): air conditioned 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hrs light / 12 hrs dark (music played during the light period).
IN-LIFE DATES: From: 1997-11-27 To: 1997-12-18
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back of the animals (free of fur)
- % coverage: 10 % of the total body surface
- Type of wrap if used: dressing (the dressing was wrapped around abdomen and fixed with an elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes (with lukewarm tap water and dried with disposable paper towels)
- Time after start of exposure: 24 hrs after the application the dressing was removed
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: no
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g/mL - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female rats per dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Mortaliy/viability: four times during test day 1 and once daily during days 2-15;
Body weights: on test days 1 ( prior to administration) , 8 and 15;
Clinical signs: each animal was examined for changes in appearance and behaviour four times during day 1, and once daily during days 2-15. All abnormalities were recorded.
- Necropsy of survivors performed: yes. All animals were killed at the end of the observation period by an intraperitoneal injection of Narcoren at a dose of at least 2.0 mL/kg/bw ( equivalent to at least 320 mg sodium pentobarbitone/kg bw) and discarded after macroscopic examinations were performed. - Statistics:
- No statistical analysis were used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: Observed over a period of 14 days.
- Mortality:
- No deaths occured during the study.
- Clinical signs:
- other: No systematic or local signs of toxicity were observed during the study period. A yellow discoloration was observed at the application site immediately after removal of the dressing up to test day 3 for the male animals and test day 6 for female animals.
- Gross pathology:
- No macroscopic findings were observed at necroscopy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The median lethal dose of T002019 after single dermal administration to rats of both sexes observed over a period of 14 days is: LD50 (rat) grater than 2000 mg/kg bw.
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