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EC number: 943-342-4 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
A study was performed to assess the acute oral toxicity of dibenzylbenzene, ar-methyl derivative, hydrogenated in the Wistar strain rat. A group of 3 fasted females was treated with the test item at a dose level of 2000 mg/kg body weight. This was followed by a further group of 3 fasted females at the same dose level. Dosing was performed sequentially. The test item was administered orally undiluted. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) in the female Wistar strain rat after a single oral administration, observed over a period of 14 days was estimated to be greater than 2000 mg/kg body weight.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October - December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
- 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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate Good Laboratory Practice: The Department of Health of the Government ot the United Kingdom, Statement of compliance in accordance with Directive 2004/9/EC, date of inspection 05/07/2016
- Test type:
- acute toxic class method
- Specific details on test material used for the study:
- - Lot/batch No.of test material: hydrogenius 005
- Expiration date of the lot/batch: > 3 years (unlimited shelf life)
- Storage condition of test material: room temperature in the dark
- Purity: 100% - Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Limited
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 161 - 177 g
- Fasting period before study: yes, overnight befor dosing, after dosing approx. 3-4 hours
- Housing: in groups of 3 in suspended solid-floor polypropylene cages furnished with wood flakes
- Diet: free access to 2014C Teklad Global Rodent diet supplied by Envigo RMS (UK) Limited
- Water: free access to mains drinking water
- Acclimation period: 5 days at least
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15 at least
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2016-10 26 To: 2016-12-05 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- ADMINISTRATION:
- Doses: single doses of 2000 mg/kg bw
- Volume administered: 2.20 ml/kg bw due to specific gravity of 0.913 - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Post dose observation period: 14 days
EXAMINATIONS: Observation for clinical signs after 30 minutes, 1, 2, 4 hours after dosing and daily thereafter. Mortality and morbidity check twice daily, early and later during normal working days, and once daily at weekends or public holidays. Individual body weights were recorded prior to dosing and 7 and 14 days after. After 14 days the animals were killed by cervical dislocation and subjected to gross pathological examination, consisiting of an external examination and opening of the abdominal and thoracic cavities for examination of major organs. The appearance of any macroscopic abnormalities were recorded, no tissues were retained. - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No animal died during the 14 day post-dose observation period.
- Clinical signs:
- No signs of systemic toxicity were noted during the observation period.
- Body weight:
- Changes in body weight observed during the period of the study were within the range expected for this strain and age of animal.
- Gross pathology:
- No abnormalities were found on necropsy of animals performed on tennination of the study.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The lack of mortality demonstrates the LD50 to be in excess of 2000 mg/kg body weight.
- Executive summary:
The study wss performed to assess the acute oral toxicity of the test item in the Wistar strain rat. A group of 3 fasted females was treated with the test item at a dose level of 2000 mg/kg body weight. This was followed by a further group of 3 fasted females at the same dose level. Dosing was performed sequentially. The test item was administered orally undiluted. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy.
The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat after a single oral administration, observed over a period of 14 days was estimated to be greater than 2000 mg/kg body weight.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 1
Additional information
Justification for classification or non-classification
Based on the available acute toxicity information, Dibenzylbenzene, ar-methyl derivative, hydrogenated does not present an acute oral toxicity hazard and does not require classification according Regulation (EC) No 1272/2008.
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