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Diss Factsheets
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EC number: 421-450-8 | CAS number: 154702-15-5
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: estimated
- Reliability:
- 1 (reliable without restriction)
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Data source
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline followed
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- 2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
Constituent 1
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- The results of the toxicity study conducted with the test substance by gavage showed that it was absorbed and distributed systemically while when administered by dermal route, lack of absorption did not lead to any toxic effect. Excretion in urine is deemed to be realistic when absorbed.
- Executive summary:
The present assessment of the absorption, distribution, metabolism and excretion of UVASORB HEB is derived from data produced for the notification submitted as for EEC 92/32 as well as the OECD 421 combined study performed as for the Annex VIII of the REACH regulation.
Toxicity
Acute oral toxicity in rats: in the limit test at a fixed dose of 2000 mg/kg no significant treatment related effects were seen. In such study LD50 was higher than 2000 mg/kg.
The repeated administration in the 13-week toxicity study in rodent by oral (into the diet) did not showed any effects. NOAEL is considered to be 831 mg/kg/day for males and 963 mg/kg/day for females.
The lack of general effects and of the target organ toxicity does not lead to concluded that the test item is adsorbed and distributed systemically.
A combined OECD 421 Reproduction/Developmental Toxicity Screening Test by gavage showed some effects related to treatment at the high dose applied (1000 mg/kg/day). NOAEL was recorded at 500 mg/kg/day for toxicity. It is therefore clear that the substance was absorbed via gastro-enteric mucosa and distributed systematically. No effect were seen on mating activity (fertility) and on F1 animals.
No information are available concerning excretion rates.
Skin and eye irritation did not show any local or systemic toxicity; in the eye irritation study the animals treated showed slight redness fully reversible within 48 hours post instillation. In the skin sensitisation study the test item did not show any degree of allergenicity.
Mutagenicity
The test substance was not mutagenic in the bacterial mutation assay and in the "in vitro" chromosome aberration study using CHO, with and without metabolic activation system as well as in the mouse lymphoma test. These studies also demonstrated that no difference of behaviour has been showed after metabolic activation of the substance with S9mix. Toxicity is therefore not induced or enhanced by the metabolism of the substance.
Assessment
The effects seen suggest a possible absorption by GI tract ; the log Pow value suggests that the test substance probably will not bioaccumulate in aquatic organisms and that no secondary poisoning through the food chain may be realistic.
The acute and repeated dermal toxicity study in rats were not carried out on the basis of the very low absorption rate (less than 0.1%) seen in the “in vitro” percutaneous absorption study using human skin. In such study UVASORB HEB has been showed to have a percentage of absorption lower than 0.1 % when applied with oil-in water emulsion or isopropyl myristate after 24 hours. No skin absorption was observed when applied as a powder. The test substance is not absorbed systemically and hence could not show toxic potential.
Skin sensitisation study did not show a sensitisation potential.
Conclusion
The results of the toxicity study conducted with the test substance by gavage showed that it was absorbed and distributed systemically while when administered by dermal route, lack of absorption did not lead to any toxic effect.
Excretion in urine is deemed to be realistic when absorbed.
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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