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EC number: 201-816-1 | CAS number: 88-27-7
- 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
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Endpoint summary
Administrative data
Description of key information
The study with the longest duration and lowest NOAEL was chosen as key study (read-across approach).
Klimisch 2. Read-across approach.
The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: read-across from several repeated dose toxicity studies, including chronic data
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach.
- Principles of method if other than guideline:
- Read-across approach from data on an analogue.
- GLP compliance:
- no
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Critical effects observed:
- not specified
- Conclusions:
- Based on experimental data, the read-across approach is applied and the NOAEL is considered to be 30 mg/kg bw/day.
- Executive summary:
The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach.
Based on experimental data, the read-across approach is applied and the NOAEL is considered to be 30 mg/kg bw/day.
Reference
The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach.
As indicated in the European Chemical Agency Practical Guide 6 “How to report read –across and categories”, the structural grouping was realized using “OECD QSAR APPLICATION TOOL BOX” (see attachment).
Table 1: Data Matrix, Analogue Approach
CAS Number
|
128-37-0 |
88-27-7 |
|
CHEMICAL NAME
|
Analogue 2,6-di-tert-butyl-4-methylphenol
|
Target chemical 2,6-di-tert-butyl-4-[(dimethylamino)methyl]phenol |
|
PHYSICO-CHEMICAL DATA |
|||
Melting Point |
Experimental results: 69.8 - 71 ºC |
Experimental results: Handbook: 94 ºC |
|
Boiling Point |
Experimental results: 265 ºC |
Weight of evidence: Handbook: 179 ºC (40 mm Hg) Estimated data: Boiling point EPISUITE = 336.78 ºC (Adapted Stein & Brown method) (MPBPWIN v1.43) |
|
Density |
Experimental results: 1.048 at 20 ºC |
Experimental results: 1.023 at 20 ºC |
|
Vapour Pressure |
Experimental results: 3.82 Pa at 24.85 ºC |
Estimated data: Vapour pressure EPISUITE = 1.69E-005 mm Hg at 25 ºC (Modified Grain method) (MPBPWIN v1.43) 0.00226 Pa at 25 ºC (Modified Grain method) (MPBPWIN v1.43) |
|
Partition Coefficient (log Kow) |
Experimental results: Log Pow = 5.2 |
Estimated data: The calculated partition coefficient is 4.24 (EPI Suite, KOWWIN v1.68 estimate). |
|
Water solubility
|
Experimental results: 0.4 -0.6 mg/l at 20-25 ºC |
Experimental results: 10.7 mg/L at 20 ºC (pH 9.2) |
|
ENVIRONMENTAL FATE and PATHWAY |
|||
Aerobic Biodegradation
|
Estimated data: Not readily biodegradable
|
Estimated data: No readily biodegradable (BIOWIN v4.10)
|
|
Anaerobic Biodegradation |
No data |
No data |
|
ENVIRONMENTAL TOXICITY |
|||
Acute Toxicity to Fish |
Estimated data: ECOSAR LC50 (96 h) = 0.2 mg/l |
Key study: Estimated data: 96-h LC50 for fish is 1.346 mg/l (ECOSAR v1.00a, phenol amines class). 96-h LC50 for fish is 2.092 mg/l (ECOSAR v1.00a, aliphatic amines class). 96-h LC50 for fish is 0.907 mg/l (ECOSAR v1.00a, phenols class).
|
|
Acute Toxicity to Aquatic Invertebrates
|
Experimental results: EC50 (48 h) =mg/L |
Key study: Estimated data: 48-h LC50 for Daphnia is 0.659 mg/l (ECOSAR v1.00a, phenol amines class) 48-h LC50 for Daphnia is 0.335 mg/l (ECOSAR v1.00a, aliphatic amines class) 48-h LC50 for Daphnia is 0.746 mg/l (ECOSAR v1.00a, phenols class)
|
|
Toxicity to Aquatic Plants
|
Estimated data: ECOSAR EC50 (96 h) = 0.76 mg/L |
Key study: Estimated data: 96-h EC50 for green algae is 0.644 mg/l (ECOSAR v1.00a, phenol amines class). 96-h EC50 for green algae is 0.297 mg/l (ECOSAR v1.00a, aliphatic amines class). 96-h EC50 for green algae is 2.760 mg/l (ECOSAR v1.00a, phenols class).
|
|
MAMMALIAN TOXICITY |
|||
Acute Oral |
Experimental results: LD50 >6000 mg/kg bw (rats)
|
Experimental results: LD50 = 461 mg/kg
|
|
Acute Inhalation
|
No data |
No data |
|
Acute Dermal |
Experimental results: LD50 >2000 mg/kg bw (rats)
|
Experimental results: LD50 > 4000 mg/kg
|
|
Skin irritation / Eye irritation |
No data |
Experimental results: Not a skin irritant. Eye irritant.
|
|
Skin sensitisation |
Experimental results: Weight of evidence: Not a skin sensitizer.
|
Experimental results: Skin sensitiser. |
|
Repeated Dose |
Experimental results: Weight of evidence: NOAEL from chronic study: 25 mg/kg bw/day
|
Read-across: NOAEL from chronic study: 30 mg/kg bw/day
|
|
Genetic Toxicity in vitro
|
Gene mutation in bacteria
|
Experimental results: Negative |
Read-across: Negative |
Chromosomal aberration
|
Experimental results: Weight of evidence: Negative |
Read-across: Negative
|
|
Mammalian gene mutation
|
Experimental results: Weight of evidence: Negative |
Read-across: Negative |
|
Genetic Toxicity in vivo
|
Experimental results: Weight of evidence: Negative |
Read-across: Negative |
|
Carcinogenicity
|
Experimental results: Weight of evidence: Not classified as carcinogenic. |
No data |
|
Reproductive Toxicity: developmental toxicity |
Experimental results: Weight of evidence:
Effects on fertility: NOAEL: 25 mg/kg bw/day in the rat.
Developmental toxicity: No data |
Read-across: Effects on fertility: NOAEL: 30 mg/kg bw/day in the rat.
Developmental toxicity: No data
|
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 30 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Klimisch 2. Read-across approach.
The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach.
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The study with the longest duration and lowest NOAEL was chosen as key study (read-across approach).
Justification for classification or non-classification
Based on the available data, the substance is not classified for repeated dose 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.
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