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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 239-816-9 | CAS number: 15721-78-5
- 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
Oral route:
The LD50 of Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is greater than 5000 mg/kg (Biosearch, 1979).
Inhalation route:
The LD50 of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is greater than 5.8 mg/l (Biosearch, 1979).
Dermal route:
Dermal exposure to bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered unlikely, therefore, this endpoint is waived.
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:
- From 23 January to 6 June 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted in a similar manner to validated testing guidelines. Study pre-dates GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Principles of method if other than guideline:
- One group of ten (5 male & 5 female) albino rats of the Sherman-Wistar Strain were employed in this study. Each animal was weighed and dosed by direct administration of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine into the stomach by means of a syringe and dosing needle. Following 14 days observation period during which time the rats were observed for signs of toxicity and mortalities.
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Sherman-Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 200-300 gm
- Fasting period before study: 24 hours
- Water (e.g. ad libitum): ad libitum
no additional data - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 25% w/v
No additional data - Doses:
- 5.0 gm/kg
- No. of animals per sex per dose:
- 5 males/5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at least once daily. The body weight in the preliminary study was recorded immediately.
-Necropsy of survivors performed: yes, Gross pathologic examination revealed nothing remarkable.
-Other examinations performed: clinical signs, body weight - Statistics:
- None stated
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities were observed.
- Clinical signs:
- other: There were no unusual behvioral signs noted.
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Other findings:
- No information provided
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine when studied in male and female albino rats has an acute oral LD50 greater than 5.0 gm/kg.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
- Quality of whole database:
- 1
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 29 January to 12 February 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted in a similar manner to validated testing guidelines. Study pre-dates GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- One group of ten (5 male and 5 female) albino rats was used in this study. The rats were placed in a 70 liter, all glass exposure chamber and exposed air for one hour. Following 14 days observation period during which time the rats were abserved for signs of toxicity and mortalities.
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- None stated.
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE
- Exposure apparatus: Glass exposure chamber
- Exposure chamber volume: 70 liter
- Source and rate of air: The rate of flow was 10 liters per minute.
- Temperature, humidity, pressure in air chamber: 70 °F
VEHICLE
- Composition of vehicle (if applicable): Corn oil.
- Concentration of test material in vehicle (if applicable): 25% w/v
No additional data - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Differential weighing
- Duration of exposure:
- 1 h
- Concentrations:
- 5.8 mg/litre during the exposure period. This is an average value over the one hour period.
- No. of animals per sex per dose:
- 5 male and 5 female per dose.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Observed once daily, weighed on initial day and final day.
- Necropsy of survivors performed: yes, Gross pathologic examination revealed nothing remarkable.
- Other examinations performed: Clinical signs, body weight. - Statistics:
- None stated
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.8 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- No mortality were observed.
- Clinical signs:
- other: There were no unusual behavioral signs noted.
- Body weight:
- All animals gained normal body weight gain.
- Gross pathology:
- Gross pathologic examination revealed nothing remarkable.
- Other findings:
- No information provided.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine has an inhalation LC50 greater than 5.8 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- 1
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral route
In a study conducted similar or equivalent to OECD 420 (pre-dates GLP), male and female albino rats were exposed to bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine. (Biosearch, 1979). In this study the LD50 of the substance is >5,000 mg/kg (Biosearch, 1979).
Inhalation route
In a study conducted similar or equivalent to OECD 403 (pre-dates GLP), male and female were exposure to Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine via aerosol (Biosearch, 1979). In this study the LC50 of the substance is >5.8 mg/L (Biosearch, 1979).
Dermal route
According to Column 2 of Annex VIII of the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) 1902/2006 regulation, a dermal toxicity study does not need to be conducted if exposure of humans via skin contact unikely. Dermal exposure to bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered unlikely, therefore, this endpoint is waived.
In addition oral and inhalation toxicity studies are available.
Justification for selection of acute toxicity – oral endpoint
Key study, equivalent or similar to OECD 420, pre-dates GLP.
Justification for selection of acute toxicity – inhalation endpoint
Key study, equivalent or similar to OECD 403, pre-dates GLP.
Justification for classification or non-classification
Acute toxicity - Oral:
The acute oral LD50 of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is >5,000 mg/kg in rats, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1 bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amineis not classified for Acute Oral Toxicity.
Acute toxicity - Inhalation:
The acute inhalation LC50 of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is > 5.8 mg/L in rat, therefore, according to Regulation EC No. 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Table 3.1.1, bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is not classified for acute inhalation toxicity.
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.