Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 258-649-2 | CAS number: 53585-53-8
- 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
Available information indicate that the Dibenzylbenzene, ar-methyl derivative is practically not toxic after single oral (LD50 > 10360 mg/kg), dermal (LD0 > 2000 mg/kg) or inhalative (LC0 > 0.24 mg/m³) exposure.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: AFNOR T03-021
- Deviations:
- yes
- Remarks:
- the age of the animals at study initiation or the individual results (bodyweight, clinical signs) were not reported.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS:
- Source: Charles River France (76410, Saint-Aubin-lès-Elbeuf)
- Age: 6 weeks
- Weight at study initiation: 184 g (males) and 153 g (females)
- Number of animals per dose group: 5 males + 5 females
- Controls: 5 males + 5 females received the same volume of sterile distilled water.
- Fasting period before study (with water): yes, 18 to 19 hours before treatment
- Housing: 5/polycarbonate cage (40.8 cm x 33.3 cm x 15 cm)
- Diet (e.g. ad libitum): rodent diet ad libitum
- Water (e. g. ad libitum): ad libitum in 500-800 mL feeding bottle
- Acclimatation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 50+/-20
- Air changes (per hr): 15
- Photoperiod (hrs dark/hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Dosage-volume: 10 mL/kg
- Doses:
- 10360 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- EXAMINATIONS:
- Post dose observation period: 14 days
- Clinical signs: examined at least once a day
- Mortality: recorded at least once a day
- Body weight: measured just before administration and then on days 6 and 14.
- Necropsy:
. macroscopic examination of the main organs such as digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities.
. microscopic examination: no - Statistics:
- no
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 10 360 mg/kg bw
- Mortality:
- No deaths were recorded.
- Clinical signs:
- other: A piloerection was observed in all the treated animals approximately 4.5 hours after administration. However, it was no more observed the following day.
- Gross pathology:
- No abnormalities were observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD0 was > 10360 mg/kg.
- Executive summary:
The acute oral toxicity of Dibenzylbenzene, ar-methyl derivative was tested on male and female Sprague-dawley rats at the limit dose of 10360 mg/kg. No mortality was observed during the exposure and 14 days following the exposure. Piloerection was noted in all the treated animals, 4.5 hours after the administration of Dibenzylbenzene, ar-methyl derivative but was no more observed the following day. No differences in body weight gain or in macroscopic findings were observed.
Under these experimental conditions, the LD0 was consider to be > 10360 mg/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- > 10 360 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Analytical concentrations are lacking, two different batch numbers are reported.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- The temperature measured at the end of the experiment was 26°C, above the recommended limit of 25°C; only one concentration was tested; there was no monitoring of the test atmosphere: test concentration, particle size and oxygen level not measured
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: IFFA CREDO, France
- Age at study initiation: not reported
- Weight at study initiation: 180-192 g (mean: 184,5g)
- Fasting period study: not reported
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): sourifarrat 18%, ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure
- Acclimatation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): 8
- Photoperiod (hrs dark /hrs light): 12/12
IN-LIFE DATES: not reported - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE/CHAMBER DESCRIPTION
- Exposure apparatus: stainless steel cage
- Exposure chamber volume: 350 x 240 x 200 mm (100 L)
- Method of holding animals in test chamber: 5/sex/cage
- Source and rate of air: pure air passed through a debimeter, the rate was 1000 L/h
- Method of conditioning air: not indicated
- System of generating particulates/aerosols: pure air passed through a debimeter, then in a 500-mL erlenmeyer containg 350 mL of the substance, heated at 70°C by thermo-shaking, and then delivered to the exposure chamber
- Method of particle size determination: particle size not determined
- Treatment of exhaust air: not reported
- Temperature, humidity, pressure in air chamber:
beginning: 22°C and 45% humidity
end: 27°C and 53% humidity
- air changes (per hr): 10
TEST ATMOSPHERE
- Brief description of analytical method used: theoretical nominal concentration calculated by the ratio between the weight of substance per time unit (determined by the difference in the weight of the erlenmeyer) and air volume that passed into the exposure chamber during this time unit.
- Samples taken from breathing zone: no
VEHICLE: air
- Theoretical concentration of test material in vehicle (if applicable): 0.24 mg/L
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: not determined
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): not determined - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 4 h
- Concentrations:
- 0.24 mg/l
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation and weighing on days 1, 2, 4, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- Not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- > 0.24 mg/L air
- Exp. duration:
- 4 h
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: - During exposure: after an initial agitation, sedation occurred (10 minutes after the start of exposure). After 30 minutes, eyes were closed but reactivity to noise was normal. Afterwards, behaviours were normal.- After exposure: normal behaviour
- Body weight:
- No effect was observed on the body weight.
- Gross pathology:
- No abnormalities were observed at the necropsy.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No mortality was found at the dose level of 0.24 mg/L. In the absence of data at higher concentrations, the substance should be classified as toxic,
however a supporting study with dibenzyltoluene heated at 700°C (Ineris, 1993) indicated that LC0 was higher than 15,8 mg/L and thus the
substance was not classified for acute inhalation. - Executive summary:
The acute inhalation toxicity of Dibenzylbenzene, ar-methyl derivativewas evaluated in a 4-hour, single-exposure study in rats at the concentration of 0.24 mg/L, according to a protocol study close to OECD Guideline 403 (May 12th1981) with acceptable restrictions.
Mortality, clinical observations for clinical signs and body weight changes were evaluated over a 14-day observation period.All animals were subjected to a gross necropsy.
No mortality was observed. During the exposure, initial agitation was first observed before sedation occurred (10 minutes after the start of exposure). After 30 minutes, eyes were closed but reactivity to noise was normal. Afterwards and until the end of the observation period, behaviours were normal. No abnormalities were observed at necropsy.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC0
- Value:
- > 0.24 mg/m³ air
- Physical form:
- inhalation: vapour
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1990-08-17 to 1990-09-03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Specific details on test material used for the study:
- The purity of the material used for the test was lower than the purity of the actual material. It contained ca. 26% of isomers of dimethyl tribenzenes. However, based on comparable basic structure of the impurities and the assumption that any toxic effects would increase with higher molecular weight and lipophilicity, we regard that the studies conducted with the lower purity material being "worst case" and can be used for the evaluation of the actual product.
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 196 - 209 g (male); 187 - 194 g (female)
- Fasting period before study: not mentioned
- Housing: collective housing up to a maximum of 5 animals per cage (Macrolon type III)
- Diet (e.g. ad libitum): Ssniff-R complete feed ad libitum, Ssniff Spezialdiäten GmbH, Soest, Germany
- Water (e.g. ad libitum):drinking water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 50 - 85
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1990-08-08 To: 1990-09-03 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: roughly 5 x 10 cm on the back of each animal
- % coverage: not mentioned
- Type of wrap if used: porous gauze dressing and Elastoplast (Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not mentioned
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0,38 - 0,42 mL - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations: 10 min, 1 h, 2 h, 6 h, 24 h after patch removal, and thereafter once daily up to day 14; skin reactions: once daily for 14 days after patch removal; weighing: before treatment (day 0) and surviving animals were reweighed on days 7 and 14 (termination)
- Necropsy of survivors performed: yes
- Other examinations performed:
Clinical observations: In each animal a number of clinical-toxicological signs were evaluated according to a modified Irwing-Screening procedure (Screening Methods in Pharmacology, R.A. Turner, 1965, p.26). Any changes from the normal condition was noted (increase or decrease) and the degree of severity of any clinical symptoms was assessed.
Skin reactions: After patch removal, dermal irritation was evaluated according to a scheme bazed on Draize - Statistics:
- LD50 values were calculated according to Finney D.Y., Probit Analysis, 3rd edition, Cambridge, 1971
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no deaths occurred in the course of the study
- Clinical signs:
- other: no abnormal clinical signs were observed, no signs of erythema and oedema were observed
- Gross pathology:
- no test substance related findings were observed
- Other findings:
- - Potential target organs: not identified
- Other observations: no sex-specific differences were found - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 after dermal application was found to be greater than 2000 mg/kg.
- Executive summary:
The acute dermal toxicity of Dibenzylbenzene, ar-methyl derivative was tested in male and female Wistar rats at the limit dose of 2000 mg/kg. No mortality was observed during the exposure and 14 days following the exposure. Under the conditions of the study, the LD50 was considered to be > 2000 mg/kg.
- 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 national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: AFNOR NF T 03-033
- Deviations:
- yes
- Remarks:
- . The following parameters were missing: the age of animals at study start, the temperature, humidity and air changes during acclimation period.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: GWEN MEUR, France
- Age at study initiation : not reported
- Weight at study initiation : 2.5 +/- 0.1 kg
- Fasting period before study: not reported
- Housing: individually in cage of 540 x 360x 315 mm
- Diet (e.g. ad libitum): 150 g of commercial granules given daily
- Water (e.g. ad libitum): filtered water ad libitum
- Acclimation period : 8 days
ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark/hrs light): 12/12 - Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 225 cm2 (15 x15 cm) on the back
- % coverage: not reported
- Type of wrap if used: adhesive
REMOVAL OF TEST SUBSTANCE
-Washing (if done): skin is wiped with a gauze pad, rinsed with tepid water and dried with paper.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1,98 ml/kg
- Concentration (if solution) : 1.01 g/mL - Duration of exposure:
- 24
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observation and weighing on Days 1, 4, 7, 11 and 14
- Necropsy of survivors performed: dermal reactions - Statistics:
- Student's test
- Preliminary study:
- No mortality was observed at any dose level.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: No observed effects.
- Gross pathology:
- No abnormalities were revealed at necropsy.
- Other findings:
- CUTANEOUS FINDINGS:
In all the treated animals, a slight irritation was noted (grade 1 erythema). It disappeared on the second week. A slight cutaneous dryness was
observed between day 5 and day 10. A pelling occured between day 6 and day 11. No oedema was found at any moment. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 of the substance was found to be greater than 2000 mg/kg/bw. Therefore, no classification for acute dermal toxicity is required.
- Executive summary:
The acute dermal toxicity of Dibenzylbenzene, ar-methyl derivative was determined in rabbits in a limit test (2000 mg/kg bw) performed according the French Guideline AFNOR NF T03 -333. The mortality and general behavior of the animals were observed for a period of 14 days after the administration of the substance.
No mortality was observed at the dose-level of 2000 mg/kg. The general behavior and the bodyweight of the animals were not influenced by the treatment.
The dermal LD50 of the substance was found to be greater than 2000 mg/kg bw; therefore, no classification for acute dermal toxicity should be required.
Referenceopen allclose all
Table: Number of animals dead [and with evident toxicity]
Dose |
Mortality (# dead/total) |
Time range of deaths (hours) |
Number with evident toxicity (#/total) |
||||
Male |
Female |
Combined |
Male |
Female |
Combined |
||
2000 |
0/5 |
0/5 |
0/10 |
n.a. |
0/5 |
0/5 |
0/10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD0
- Value:
- > 2 000 mg/kg bw
Additional information
The acute toxicity of Dibenzylbenzene, ar-methyl derivative was evaluated in various studies, using oral and dermal exposure, as well as exposure via inhalation. All data demonstrate that Dibenzylbenzene, ar-methyl derivative is of low toxicity after single administration. The LD50 values after oral and dermal application are above 2000 mg/kg bw. No mortality was observed after a single exposure to the registered substance at up to 0.24 mg/L for four hours and to its combustion products at up to 15.6 mg/L for one hour.
Oral acute toxicity
The acute oral toxicity of Dibenzylbenzene, ar-methyl derivative was tested on male and female Sprague-dawley rats at the limit dose of 10360 mg/kg. No mortality was observed during the exposure and 14 days following the exposure. Piloerection was noted in all the treated animals, 4.5 hours after the administration of Dibenzylbenzene, ar-methyl derivative but was no more observed the following day. No differences in body weight gain or in macroscopic findings were observed.
Under these experimental conditions, the LD0 was consider to be > 10360 mg/kg.
Inhalation acute toxicity
The acute inhalation toxicity of Dibenzylbenzene, ar-methyl derivativewas evaluated in a 4-hour, single-exposure study in rats at the concentration of 0.24 mg/L, according to a protocol study close to OECD Guideline 403 (May 12th1981) with acceptable restrictions.
Mortality, clinical observations for clinical signs and body weight changes were evaluated over a 14-day observation period.All animals were subjected to a gross necropsy.
No mortality was observed. During the exposure, initial agitation was first observed before sedation occurred (10 minutes after the start of exposure). After 30 minutes, eyes were closed but reactivity to noise was normal. Afterwards and until the end of the observation period, behaviours were normal. No abnormalities were observed at necropsy.
Dermal acute toxicity
The acute dermal toxicity of Dibenzylbenzene, ar-methyl derivative was determined in rabbits in a limit test (2000 mg/kg bw) performed according the French Guideline AFNOR NF T03 -333. The mortality and general behavior of the animals were observed for a period of 14 days after the administration of the substance.
No mortality was observed at the dose-level of 2000 mg/kg. The general behavior and the bodyweight of the animals were not influenced by the treatment.
The dermal LD50 of the substance was found to be greater than 2000 mg/kg bw; therefore, no classification for acute dermal toxicity should be required.
Justification for classification or non-classification
No classification for acute toxicity is indicated according to the classification, labeling and packaging (CLP) regulation (EC 1272/2008).
However, hydrocarbons with viscosity below 20 mm²/s at 40 °C poses aspiration hazard : Asp. Tox. 1 (H304).
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.