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EC number: 205-027-3 | CAS number: 131-54-4
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October 1965
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October 1965
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA procedure
- Version / remarks:
- The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
- Deviations:
- not specified
- Principles of method if other than guideline:
- Test item was applied as powder onto intact and abraded skin of rabbits.
- GLP compliance:
- no
- Remarks:
- conducted prior to GLP implementation
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- none stated
- Type of coverage:
- not specified
- Preparation of test site:
- other: intact and abraded
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- and 16, 8, and 4 % in each dimethyl phthalate and petrolatum
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100% powder - Duration of treatment / exposure:
- The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
- Observation period:
- The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
- Number of animals:
- 6
- Details on study design:
- The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 16% in dimethyl phthalate
- Time point:
- other: not specified
- Score:
- 0.25
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 16% in petrolatum
- Time point:
- other: not specified
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 8% in both solvents
- Time point:
- other: not specified
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- 4% in both solvents
- Time point:
- other: not specified
- Score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: information not given
- Irritation parameter:
- edema score
- Time point:
- 24/48/72 h
- Remarks on result:
- other: information not given
- Interpretation of results:
- other: not irritating
- Conclusions:
- Given information indicates that the study was performed scientifically reasonable, so the results are considered sufficiently reliable to assess the irritating potential of the registered substance in rabbits. The information is given as primary irritation index, which does not allow classification according to Regulation 1272/2008 in its classic sense. However, the regulation allows to retrieve information on classification also from other sources. As the PMII was consistently zero except once (0.25), it can be reasonably concluded that the substance would also not meet the classification criteria as set out in the regulation, so the substance can be considered non-irritating to the skin.
- Executive summary:
The rabbit irritation test followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act. The substance was applied to intact and abraded rabbit skin undiluted, or as 16, 8, or 4% solution in each dimethyl phthalate and petrolatum. The substance was found to be non-irritating.
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 1965
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA procedure
- Version / remarks:
- The rabbit tests followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act.
- Deviations:
- not specified
- Principles of method if other than guideline:
- 0.1 ml / 100 mg of the test item were istilled into the eyes of rabbits
- GLP compliance:
- no
- Remarks:
- conducted prior to GLP implementation
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- none stated
- Vehicle:
- other: undiluted or 16, 8, or 4% in each dimethyl phthalate and petrolatum
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml / 100 mg
- Duration of treatment / exposure:
- no wash-out
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- at any observation timepoint or concentration
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- positive indication of irritation
- Remarks:
- at any observation timepoint or concentration
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- at any observation timepoint or concentration
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- at any observation timepoint or concentration
- Irritant / corrosive response data:
- The test material produced no discernible effects in the eyes of the rabbits.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Given information indicates that the study was performed scientifically reasonable, so the results are considered sufficiently reliable to assess the irritating potential of the registered substance in rabbits. The information is given as overall mean irritation value including all four scores (cornea, iris, conjunctivae, chemosis), which was consistently zero, so these results may be used nevertheless for classification according to Regulation 1272/2008. As all values were zero over all observation time points, it can b ereasonably concluded that no classification as eye irritant according to Regulation 1272/2008 is triggered.
- Executive summary:
The rabbit irritation test followed the protocols described in the regulations for the U.S. Federal Hazardous Substances Labeling Act. 0.1 ml of each of the six concentrations (16, 8, or 4% in each dimethyl phthalate and petrolatum) was instilled into the left eye of albino rabbits (six rabbits for each concentration). The eyes were not washed. No effects at all were observed.
In addition, when tested as the 100% powder (100 mg in right eye of each of six rabbits, unwashed, as above), no discernible effects were observed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 965
- Report date:
- 1965
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not applicable
- Principles of method if other than guideline:
- The test item (Benzophenone-6 25% in corn oil) was administered in various doses to groups of 5 rats.
- GLP compliance:
- no
- Remarks:
- conducted prior to GLP implementation
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2,2'-dihydroxy-4,4'-dimethoxybenzophenone
- EC Number:
- 205-027-3
- EC Name:
- 2,2'-dihydroxy-4,4'-dimethoxybenzophenone
- Cas Number:
- 131-54-4
- Molecular formula:
- C15H14O5
- IUPAC Name:
- 2-(2-hydroxy-4-methoxybenzoyl)-5-methoxyphenol
- Test material form:
- other: suspension in corn oil
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino Sherman-Wistar
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Fasting period before study: 24h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: test item is a 25% suspension of the registered substance in corn oil
- Details on oral exposure:
- test item is a 25% suspension of the registered substance in corn oil
- Doses:
- 1, 2, 4, 8, 16 g/kg of a 25% suspension of the registered substance in corn oil
- No. of animals per sex per dose:
- 5 / dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortalities, daily
Results and discussion
Effect levelsopen allclose all
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 16 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Remarks:
- act. ingr. is registered substance
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- >= 16 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortalities observed
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD0
- Effect level:
- >= 4 000 mg/kg bw
- Based on:
- act. ingr.
- Remarks on result:
- other: no mortalities observed
- Remarks:
- act. ingr. is registered substance
- Mortality:
- no mortalities observed
- Clinical signs:
- other: not stated
- Gross pathology:
- not stated
Any other information on results incl. tables
No mortalities observed in all dose groups at every observation time point.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- EU implementation
- Conclusions:
- Given information indicates that the study was performed scientifically reasonable, so the results are considered sufficiently reliable to assess the acute toxicity of the registered substance in rats. No mortalities were observed up to the highest dose tested, i.e. 16 g/kg of a 25% suspension of the registered subtance in corn oil, so the relevant effective dose levels can be calculated for Benzophenone-6 to be LC50 > 4000 mg/kg, LD0 ≥ 4000 mg/kg, which is beyond the limit for classification as acutely toxic acc. Regulation 1272/2008 and amendments.
- Executive summary:
When dosed as a 25% mixture in corn oil, the LD50 in white rats was found to be greater than 16 g/Kilo. (No fatalities observed at highest doses practicable).
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