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EC number: 223-095-2 | CAS number: 3734-33-6
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Justification for type of information:
- data is from experimental reports following standard procedures
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Acute dermal toxicity study of denatonium benzoate (3734-33-6) was performed in rats.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: limit test
- Limit test:
- yes
Test material
- Reference substance name:
- Denatonium benzoate
- EC Number:
- 223-095-2
- EC Name:
- Denatonium benzoate
- Cas Number:
- 3734-33-6
- Molecular formula:
- C21H29N2O.C7H5O2
- IUPAC Name:
- N-benzyl-2-[(2,6-dimethylphenyl)amino]-N,N-diethyl-2-oxoethanaminium benzoate hydrate
- Test material form:
- solid: granular
- Details on test material:
- - Name of test material: Denatonium benzoate
- Molecular formula: C21H29N2O.C7H5O2
- Molecular weight : 446.58 g/mol
- Substance type: organic
- Physical state: Solid
- SMILES: CCN{+}(CC)(Cc1ccccc1)(CC(=O)Nc1c(C)cccc1C).O{-}C(=O)c1ccccc1
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N-benzyl-2-[(2,6-dimethylphenyl)amino]-N,N-diethyl-2-oxoethanaminium benzoate hydrate
-Common name: Denatonium benzoate
- Molecular formula: C21H29N2O.C7H5O2
- Molecular weight: 446.58 g/mol
- Substance type: organic
- Physical state: Solid
- Form: white granular solid
- batch no:22362
- Storage conditions: room temperature, room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Harlan U.K Ltd., Blackthron, Bicester, Oxon, U.K.
- Age at study initiation:10-14 weeks old
- Weight at study initiation: male 222-251g and female 202-232g
- Fasting period before study: Rats were not fasted prior to dosing
- Housing: The animals were housed in suspended polypropylene cage furnished with wood flakes. The animals were housed individually during the 24-hr exposure period and in group of 5 , by sex for reminder of the study.
- Diet (e.g. ad libitum): Fed ad libitum (Rat and mouse Expanded Diet no. 1, Special dies services Limited, Witham , Essex, U.k)
- Water (e.g. ad libitum):Drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):19-22°C
- Humidity (%):47-53%
- Air changes (per hr):15 changes per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by a time switch to give 12hr continuous light and 12hr darkness.
IN-LIFE DATES: From: To:
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Details on exposure
VEHICLE:
- Concentration in vehicle:2000mg
- Amount of vehicle (if gavage): no data available
- Justification for choice of vehicle: no data available
- Lot/batch no. (if required): no data available
- Purity: no data available
MAXIMUM DOSE VOLUME APPLIED: no data available
DOSAGE PREPARATION (if unusual): no data available
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: - Duration of exposure:
- 24hr
- Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not specified
- Details on study design:
- Details on study design
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for death or overt signs of toxicity ½, 1,2, and 4hr after dosing and subsequently once daily for 14 days .
Individual body weights were recorded prior to application of the test material on day 0 and on days 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathological examination was performed. The appearance of any macroscopic abnormalities was recorded. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality was observed
- Mortality:
- There were no death during study
- Clinical signs:
- other: No signs of systemic toxicity were noted during the study. No signs of skin irritation were noted during the study in nine animals. Necrosis, well- defined erythema, very slight oedema and a hardened dark brown/ black colored scab or sunken scab resemblin
- Gross pathology:
- No abnormalities were noted at necropsy
- Other findings:
- No data available
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- LD50 was considered to be >2000mg/kg body weight. When rats were treated with denatonium benzoate (3734-33-6) by dermal application.
- Executive summary:
In acute dermal toxicity study male and female Sprague – Dawley rats were treated withdenatonium benzoate(3734-33-6).The animals were housed in suspended polypropylene cage furnished with wood flakes. The animals were housed individually during the 24-hr exposure period and in group of 5 , by sex for reminder of the study. Fed ad libitum (Rat and mouse Expanded Diet no. 1, Special dies services Limited, Witham , Essex, U.k)and Drinking water ad libitum. Acclimation period was 5 days , Rats were not fasted prior to dosing. On the day before treatment the back and flanks of each animals were clipped free of hair using veterinary clippers to expose a skin area of approximately 5cmx 7cm.A group of 5 male and 5 female rats were treated with the test material at dose concentration of 2000mg/kg. The appropriate amount of the test material, as received, pre- weighed into a plastic tube, was applied uniformly to an area of shorn skin approximating to 10% of the total body surface area which had previously been moistened with distilled water .A piece of surgical gauze measuring 7 cm x4 cm was placed over the treatment area and semi occluded with a piece of self-adhesive bandage. The bandage was further secured with a piece of BLENDERM wrapped around each end. The animals were caged individually for the 24hr exposure period. Shortly after dosing the dressing were examined to ensure that they were securely in place. The animals were observed for death or overt signs of toxicity ½, 1,2, and 4hr after dosing and subsequently once daily for 14 days .Individual body weights were recorded prior to application of the test material on day 0 and on days 7 and 14 gross pathological examination was performed. The appearance of any macroscopic abnormalities was recorded.
There was no death during study.No signs of systemic toxicity were noted during the study. No signs of skin irritation were noted during the study in nine animals. Necrosis, well- defined erythema, very slight oedema and a hardened dark brown/ black colored scab or sunken scab resembling a crater were noted at the remaining test site during the study. Scab lifting to reveal dried blood and scab lifting to reveal further bleeding were also noted and an accurate evolution of the degree of erythema and/or oedema was not possible from day 5 onwards at this treatment site.All animals showed expected gain in bodyweight. No abnormalities were noted at necropsy. HenceLD50 was considered to be >2000mg/kg body weight. When rats were treated with denatonium benzoate(3734-33-6)by dermal application.
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