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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
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2001-01-22 until 2001-01-26
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
- Principles of method if other than guideline:
- Evaluation of endocrine (estogenic) effects
- GLP compliance:
- no
- Type of method:
- in vivo
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 Laboratories, Germany
- Age of the test animals (immature females) at study initiation: 20+/- 1days
- Weight at study initiation: 30.0 - 40.0 g.
- Housing: Makrolon cages, type M-ll (Becker & Co., Castrop-Rauxel Germany). 2 animals per cage.
- Diet: Pelleted Kliba maintenance diet rat/mouse/hamster, Provimi Kiba SA, Kaiseraugst, Switzerland; ad libitum
- Water: Drinking water (tap water) ad libitum
- Acclimation period: At least one day.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 2001-01-23 To: 2001-01-26
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The preparations were carried out in olive oil. For this purpose, a defined amount of the test substance was weighed into a calibrated beaker, topped up with the vehicle and then mixed with the magnetic stirrer. The test substance preparation was made once, on day of first administration.
VEHICLE
Olive oil EP/DAB
- Concentration in vehicle: 50 mg/mL and 200 mg/mL in olive oil.
- Amount of vehicle (if gavage): 5 mL/kg bw/day
- Origin and lot/batch no.: Henry Lamotte GmbH, batch: 2047001. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples were diluted in acetone. Aliquots of the dilutions were used for HPLC-analysis. The results demonstrated the correctness of the homogeneity and concentrations of 2-(4-DiethyIamino-2-hydroxybenzoyI)-benzoesäurehexylester in olive oil Ph.Eur./DAB.
- Duration of treatment / exposure:
- 3 days
- Frequency of treatment:
- Once daily
- Duration of test:
- 3 days.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 per dose.
- Control animals:
- yes, concurrent no treatment
- other: A positive control, a group with 10 rats, that received 5 µg/kg bw diethylstilbestrol dipropionate (DES-DP) that induces a distinct uterotrophic effect.
- Details on study design:
- The study included 4 groups, 10 female rats in each group. The first group was a negative control group. The rats in this group received only olive oil by gavage. The second group was used as positive control, receiving DES-DP 5µg /kg bw in olive oil. The third group received 250 mg/kg bw of the test substance in olive oil and the forth group received 1000 mg/kg bw of the test substance in olive oil. The different treatments were given once a day by gavage for three days. Body weights and any other clinical symptoms were recorded once a day. At the end of the study all rats were sacrificed and the uterus weight was examined and histopatological examination was conducted.
- Statistics:
- The mean body and uterus weights were statistically evaluated by the Dunnett-test (two sided) or the Wilcoxon-test (two-sided) with a P <=0.05 or P<0.01.
Results and discussion
Observed effects
The test substance showed no increased uterus weights as compared between the carrier control and the dosed groups (250 and 1,000 mg/kg bw). As was expected, the positive control DES-DP (5 µg/kg) led to a statistically significant increase in the absolute and relative uterus weights with a 4.7- and 4.9-fold increase respectively when compared with the control (olive oil). Histopathologically, no changes were detected in the uterus of the animals that received 250 and 1,000 mg/kg bw of DHE.
The positive control (5 µg/kg DES-DP) morphologically showed the expected changes in the uterus:
1. Endometrial epithelium extended and hypertrophic
2. Uterus lumen partially clearly dilated
3. Uterus wall thickened without any of the muscular layers or particularly the stroma being prominent.
Applicant's summary and conclusion
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