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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-01-29 until 2003-02-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
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
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sandhofer Weg 7, 97633 Sulzfeld; Germany
- Age at study initiation: Young adult animals - approx. 14- 18 weeks
- Weight at study initiation: 195 g mean weight in the first experiment and 201g in the following experiment
- Fasting: Feed was withdrawn from the animals at least 16 hours before administration of the test substance.
- Housing: Single housing in stainless steel wire mesh cages, type DK-lll (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation for at least 5 days
ENVIRONMENTAL CONDITIONS
-The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a temperature range of 20 - 24°C and of 30- 70% relative humidity.
- Photoperiod (hrs dark / hrs light): 12 h /12 h
IN-LIFE DATES: From: 2003-01-30 (first administration) To: 2003-02-19
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE- Olive oil Ph.Eur./DAB
- Concentration in vehicle: 40 g test substance / 100 mL
- Amount of vehicle: 5 mL/kg
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity of the preparation.
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
DOSAGE PREPARATION:
The test substance preparation was produced for each administration group shortly before administration by stirring with a magnetic stirrer. For a better handling the test substance was melted at about 60°C. The preparation was cooled down to body temperature.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The selection of dose was based on the physical and chemical characteristics of the test substance and its composition. As no pronounced acute oral toxicity was expected, a starting dose of 2,000 mg/kg body weight has been chosen to be given to 3 animals of a single sex per step (as instructed by the OECD 423 guideline for a acute toxic class method).
Regarding the use of the class method in the study: As none of those animals died, 2,000 mg/kg body weight were administered to another group of 3 female animals in a second step. Because no mortality occurred either the study fulfilled the criteria for a limit test and was terminated. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- In total: 6 female animals at 2000 mg/kg.
3 female animals in the first step (first experiment)
3 female animals in the second step (second experiment) - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms were done at least once a day. Individual body weights was measured shortly before administration (day 0), after one week and at the end of the study. A check for any dead or moribund animal was made twice a day.
- Necropsy with gross-pathology examination was done on the last day of the observation period after killing the animals with CO2. - Statistics:
- Not indicated (regarding body weight)
Results and discussion
- Preliminary study:
- There was no need of a preliminary study. The study was performed according to the Acute Toxic Class method
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical observations were noticed during the clinical examinations.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in the 6 examined animals.
- Other findings:
- No other findings.
Any other information on results incl. tables
No remarks.
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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