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Diss Factsheets
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EC number: 450-630-9 | CAS number: -
- 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:
- 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed in accordance with validated guidelines and in GLP compliance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-(4-bromophenyl)-2-methylpropionic acid methyl ester
- EC Number:
- 450-630-9
- EC Name:
- 2-(4-bromophenyl)-2-methylpropionic acid methyl ester
- Cas Number:
- 154825-97-5
- Molecular formula:
- C11H13BrO2
- IUPAC Name:
- methyl 2-(4-bromophenyl)-2-methylpropanoate
- Test material form:
- other: liquid
- Details on test material:
- The test material was a liquid with a degree of purity >99%.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Body weight at the commencement of the study: male 223-249 g and female 209-220 g. 5 male and 5 female animals were used.
The animals were derived from a controlled full barrier maintained breeding system (SPF).
The animals were barrier maintained (semi-barrier) in an air conditioned room
- temperature: 22 ± 3 °C
- Rel. humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: 10 x/hour
- Feeding ad libitum, ssniffRIM-H, 10 mm Vl534-000, complete diet for rats/mice- maintenance, totally-pathogen-free (TPF)
- Free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- The animals were kept in Macrolon cages on Lignocel bedding
- Certificates of food, water and bedding are filed at BSL Bioservice
- Adequate acclimatization period
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- The test item was applied as a single dose, uniformly over an area which was approx. 10% of the total body surface. The test item was held in contact with the skin with a gauze-dressing and no-irritating tape and was fixed with additional dressing in a suitable manner.
- Duration of exposure:
- 24 h
- Doses:
- The test item was applied at a single dose (2000 mg/kg bw) by applying uniformly over an area which was approx. 10% of the total body surface.
- No. of animals per sex per dose:
- 5 male animals (HsdRccHan : WIST rats) and 5 female animals (HsdRccHan: WIST rats) were used.
- Control animals:
- not required
- Details on study design:
- Animals were observed for 14 days after dosing. A careful clinical examination was made at least twice on the day of dosing and once a day thereafter.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
At the end of the observation period the animals were sacrificed by an overdosage of pentobarbital.
All animals were subjected to gross necropsy. All gross pathological changes were recorded.
Individual reactions of each animal were recorded at each observation time. Toxic response data were recorded by sex and dose level. Nature, severity and duration of clinical observations were described. Body weight changes were summarized in tabular form. Necropsy findings were described.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- Signs of toxicity related to dose levels:
no treatment related effects observed - Body weight:
- Weight gain of all animals was within the expected range
- Gross pathology:
- Effects on organs:
no treatment related effects observed - Other findings:
- Signs of toxicity (local):
no treatment related effects observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Considering the reported data of this dermal toxicity test it can be stated that the test item FEXO-03 has no acute dermal toxic characteristics. The dermal LD50 was determined to be > 2000 mg/kg bw.
- Executive summary:
The test item was administered topically at a single dose (2000 mg/kg bw) by applying uniformly over an area which was approx. 10% of the total body surface. 5 male animals (HsdRccHan : WIST rats) as well as 5 female animals (HsdRccHan: WIST rats) were used. The test item was held in contact by an occlusive dressing with the skin throughout a 24-hour period. The occlusive dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner. At the end of the exposure, residual test item was removed by using tap water. A careful clinical examination was made at least twice on the day of dosing and once a day thereafter. At the end of the observation period the animals were sacrificed and necropsy was carried out to record gross pathological changes. No clinical signs of toxicity were observed throughout the observation period. Except for acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection no special gross pathological changes were found in any animals. Weight gain of all animals was within the expected range (table 1). Therefore, according to the intemationally accepted guidelines, a sufficient estimation of the acute dermal toxicity of the test item FEX0-03 was provided.
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