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Diss Factsheets
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EC number: 224-166-0 | CAS number: 4221-80-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1979-05-23-1979-06-21
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (US, 1959)
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- Maurer optimisation test
- Justification for non-LLNA method:
- The study was conducted in 1979. By this time the LLNA was not an established method yet.
Test material
- Reference substance name:
- 2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- EC Number:
- 224-166-0
- EC Name:
- 2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
- Cas Number:
- 4221-80-1
- Molecular formula:
- C29H42O3
- IUPAC Name:
- 2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Bantin and Kingman Ltd. Grimston, Hull, England
- Weight at study initiation: 350-440 grams
- Housing: Housed indivually in Macrolon cages, type 3
- Diet: NAFAG No. 830 Gossau SG
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Photoperiod: 10 hours light cycle day
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- day 0 - day 10
Challengeopen allclose all
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.1 %
- Day(s)/duration:
- day 24
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 30 %
- Day(s)/duration:
- day 34 / 24 h
- No. of animals per dose:
- 10 males and 10 females per group
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three different injection procedures+challenge exposure+epicutaneous application:
1. One injection every second day to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of the test item in propylene glycol 100 %.
2. On the first day injection of 0.1 mL were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
3. During the second and third week of the induction period the material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant.
- Test groups: groups of 10 male and 10 females
- Control group: one control group was treated with the vehicle alone
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1: Fourteen days after the last sensitizing injection, a challenge injection of 0.1 mL of a freshly prepared 0.1 % suspension of the test item in propylene glycol 100 % was administered into the skin of the left flank.
- Evaluation (hr after challenge): 24 hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
C.EPICUTANEOUS CHALLENGE:
Ten days after the intracutaneous challenge injection a subirritant dose of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The test substance was applicated in a dose of 30 % in Vaseline. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- no positive control
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: 1st reading (intradermal challenge)
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1 %
- No. with + reactions:
- 7
- Total no. in group:
- 19
- Key result
- Reading:
- other: 1st reading (intradermal challenge)
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 4
- Total no. in group:
- 20
- Key result
- Reading:
- other: 1st reading (epicutaneous challenge)
- Hours after challenge:
- 240
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
- Key result
- Reading:
- other: 1st reading (epicutaneous challenge)
- Hours after challenge:
- 240
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 19
Any other information on results incl. tables
Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen, after either intradermal or epidermal challenge application of the test item. The test substance was found to be devoid of skin-sensitizing (contact allergenic) potential in albino guinea-pigs.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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