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Diss Factsheets
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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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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