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EC number: 221-573-5 | CAS number: 3147-75-9
- 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
Endpoint summary
Administrative data
Description of key information
- LD50 acute oral toxicity (male; rat): > 10000 mg/kg bw (reliability score: 2)
- LD50 acute dermal toxicity (male; rabbit): > 5000 mg/kg bw (reliability score: 2)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity, only males tested)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (limited documentation, maximal applicated volume > 20mL/kg bw)
- Principles of method if other than guideline:
- 5 male rats per group fasted for 24 h were dosed with a 10% aqueous dispersion of the test substance. Signs of intoxication were documented and animals were necropsied at study termination.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data - Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Mean weight at study initiation: 153 g
- Fasting period before study: 24 h - Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 10%
MAXIMUM DOSE VOLUME APPLIED: 100 mL/kg bw - Doses:
- 10,000; 5,000; 2,500; 1,250 mg/kg bw
- No. of animals per sex per dose:
- 5 (only males)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: no data
- Frequency of weighing: at initiation and termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 10 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality occurred in the highest dose group.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 10 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited documentation, no data on test substance purity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- (limited documentation, occlusive treatment), dose of 5000 mg/kg bw
- Principles of method if other than guideline:
- 10 male rabbits were treated with a paste, prepared with the test substance and diethyl succinate, for 24 h under occlusive conditions. The skin was shaved before application. Signs of intoxication as well as skin irritation were documented and animals were necropsied at study termination.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Ultraviolet Absorber P-541; Cyasorb UV-5411; 2-(2'-Hydroxy-5'-tert-octylphenyl) benzotriazole
- Physical state: solid
- Analytical purity: no data - Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Further characterisation: Albino rabbits
- Mean weight at study initiation: 2.88 kg - Type of coverage:
- occlusive
- Vehicle:
- other: diethyl succinate
- Details on dermal exposure:
- REMOVAL OF TEST SUBSTANCE
- Washing: no data
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 5000 mg/kg bw
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 h
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 10 (only males)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: no data
- Frequency of weighing: at initiation and termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortality
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No clinical signs of toxicity were observed up to the end of the observation period.
- Gross pathology:
- Necropsy revealed no substance-related findings.
- Other findings:
- Skin irritation:
Well-defined erythema were observed. - Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 5 000 mg/kg bw
Additional information
Acute Oral Toxicity
In a standard acute oral toxicity study performed similarly to OECD TG 401, groups (5 male rats/dose) of young Wistar rats were administered the test substance (no data on purity) after a 24 h fasting period. The test substance was administered at doses of 1,250, 2,500, 5,000 and 10,000 mg/kg bw in water. Animals were subsequently observed (no data on duration of observation) and clinical signs of toxicity, body weight changes and cases of mortality were noted.
Deaths did not occur at any dose level. Hence the LD50 is higher than 10,000 mg/kg bw. There were no treatment related clinical signs of toxicity, necropsy findings or changes in body weight.
This study is suitable for assessment of acute oral toxicity as it was performed using a protocol which is similar and equivalent to the deleted OECD guideline (401). Because of the high doses applied that did not induce mortality in males it can be assumed that treatment of females would not have caused mortality, either. The documented weight changes indicate an adequate observation period duration.
Acute Dermal Toxicity
In an acute dermal toxicity study a group of 10 male Albino rabbits were dermally exposed to the test substance (no data on purity) in diethyl succinate for 24 hours at a limit dose of 5,000 mg/kg bw and observed (no data on duration of observation) after treatment. Death did not occur. Hence the LD50 is higher than 5,000 mg/kg bw. Except well-defined erythema as an irritating effect, there were no treatment related clinical signs of toxicity, necropsy findings or changes in body weight.
This study is suitable for assessment of acute dermal toxicity as it was performed using a protocol which is similar and equivalent to the OECD guideline. The weight gain of the animals indicates an adequate observation period, although the information on duration is lacking. Due to the high LD 50 it can be presumed, that no female would have died, either.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data are considered reliable and suitable for the purpose of classification. Based on the criteria for classification of Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC, classification for acute toxicity is not warranted.
Classifiation, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification. Based on the criteria laid down in Regulation (EC) No. 1272/2008, as amended for the fifth time in Directive EC 944/2013, classification for acute toxicity is not warranted.
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