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EC number: 443-860-6 | CAS number: 302776-68-7
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-11-26 until 2008-05-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Objective of study:
- other: Absorption, distribution and excretion of 14C- Uvinul A Plus in rats at dose level of 100 mg/kg bw.
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.36 (Toxicokinetics)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.7485 (Metabolism and Pharmacokinetics)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan/ MAFF: Guidelines on the Compiling of Test Results on Toxicity; Tests on In Vivo Fate in Animals, 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 443-860-6
- EC Name:
- -
- Cas Number:
- 302776-68-7
- Molecular formula:
- C24 H31 N O4
- IUPAC Name:
- hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Sulzfeld Germany
- Age at study initiation: At least about 8 weeks at the date of administration
- Weight at study initiation: Mean weight for the female rats: 235.3 g. Mean weight for the male rats: 328.4 g.
- Housing: During the acclimatization and prior to the experiment in type III Macrolon cages.
During balance experiment in all-glass metabolism cages; type Metabowl (Jencons, Leighton Buzzard, UK).
During the experiment animals were housed individually with the cages being labelled with the project number, animal number, dose and time of first administration.
- Individual metabolism cages: yes
- Diet: Kliba lab diet (mouse/ rat "GLP") either pelleted (e.g . during acclimatization or in steel wire mesh cages) or as meal (e.g. in metabolism cages).
Origin: Provimi Kliba SA, 4303 Kaiseraugst, Switzerland ad libitum prior to and during the experiments.
- Water: Tap water ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20- 24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): Natural day/ light rhythm with additional artificial light as required during working hours.
IN-LIFE DATES: From: 2007-11-26 To: 2007-11-29
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- The requested details in this field are not relavent for the present study (NA- not applicabe)
- Duration and frequency of treatment / exposure:
- A single oral administration (5mL/ kg bw; 0.5-2 MBq/ animal)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Nominal dose level of 100 mg/kg bw.
- No. of animals per sex per dose / concentration:
- 24 animals
3 groups, 8 rats in each group (4 females, 4 males)
Group 1: Experiment group (bile duct cannulated at the testing laboratory) - one oral dose of 100 mg/kg bw
Group 2: Same as group 1- Repetition of the experiment
Group 3: Same treatment as in the other 2 groups (animals were delivered with bile duct catheters from the breeding lab) - Confirmation experiment - Control animals:
- no
- Positive control reference chemical:
- No positive control
- Details on study design:
- - Dose selection rationale: 100 mg/kg bw was selected to be applied in this study as it was considered to exert no adverse effects based on a subchronic toxicity study in rats (OECD 408) and it represents a technically appropriate dose for the assessment of the bioavailability of radiolabelled test substance via the oral route.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: Urine, feces, bile, cage wash
- Time and frequency of sampling: Bile excretion was collected in three-hour time intervals up to 72 hours. Urine and feces were collected in 24 hours intervals up to 72 hours.
- Other: After the experiment, animals were sacrificed and the following tissues were checked for remaining radioactivity: stomach and stomach contents, gut and gut contents, carcass.
- Statistics:
- Mean values and SD were the only (required) calculated statistical parameters in the study.
Results and discussion
- Preliminary studies:
- No preliminary studies
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- In the present study the bioavailability after single oral administration of 14C-Hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl)benzoate to rats at a dose level of 100 mg/kg bw was examined. The bioavailability was calculated as the sum of radioactivity found within 72 hours in bile (males: 11.28% , females: 19.76% of dose applied), urine (males: 13.79%, females: 22.62% of dose applied), cage wash (recoveries of 0.71% in males and 1.46% in females) and carcass (recoveries of 0.46% in males and 1.26% in females). Altogether the bioavailability was 26% and 45% of the administered dose in male and female rats respectively.
- Details on distribution in tissues:
- Not determined but radioactivity in the residual carcass was 0.46% in male animals and 1.26% of dose in female animals.
- Details on excretion:
- Total excretion of radioactivity within 72 hours:
Via bile: 11.28 % of the administered dose for male rats and 19.76 % of the administered dose for female rats.
Via urine: 13.79% of the administered dose for male rats and 22.62 % for female rats.
Via feces: 51.47% of the administered dose for male rats and 32.78% for female rats.
In cage wash: 0.71% (male rats) and 1.46 % (female rats) of the administered dose were recovered.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
The mean total recovery of radioactivity was found to be 79.84% and 88.05% of the applied dose after single oral administration of 100 mg/kg bw Hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl)benzoate
to male and female rats, respectively.Applicant's summary and conclusion
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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