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Diss Factsheets
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EC number: 202-696-3 | CAS number: 98-73-7
- 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
Endpoint summary
Administrative data
Description of key information
skin irritation, supporting study: Draize skin irritation test, albino rabbits, one male and one female, occlusive patches, 800 mg/kg bw (solid PTBBA) and 300 mg/kg bw (alcohol-mineral oil suspension). No signs of skin irritation were observed. Neither preparation caused systemic or skin changes.
skin irritation, key study: according to E.E.C. Directive 84/449/EEC appendix V B4, New Zealand albino rabbits, 6 males, semi-occlusive, 500 mg PTBBA on a moistened Codex hydrophilic gauze patch aplied to skin: Summary of results: No cutaneous reaction was observed one hour, 24, 48 and 72 hours after the removal of the dressing. The scoring was at all times "0" concerning erythema and eschar formation as well as oedema formation.
eye irritation: according to 84/449/EEC appendix V B5, New Zealand albino rabbits, 6 males, single introduction of 100 mg (left eye):
Summary of results: One hour after the introduction of the test substance, moderate conjunctival reactions and slight discharge were observed in all the animals. After 24 hours, the conjunctival reactions regressed and were slight in all the animals and minimal corneal opacity was noted in 2 animals. After 48 hours, only slight conjunctival lesions persisted in one animal. After 72 hours, no ocular reaction was noted.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Although info about the batch of the tested substance is delivered, no info about its purity is given; statement that the study was performed in accordance with GLP guidelines but no provision of a certificate; info about the vehicle/application of the substance lacks some information details. The study was performed in accordance with an official guideline. The methodology, evaluation of the results and the results themselves are well documented.
- Qualifier:
- according to guideline
- Guideline:
- other: E.E.C. Directive 84/449/EEC appendix V B4
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: "New-Zealand albino rabbits"
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles-en-Mauges, France)
- Sex: all males
- weight on day of treatment: 2.5 +/- 0.1 kg
- identification of individuals by ear-tags - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Controls:
- other: on each animal was a control site and a test site
- Duration of treatment / exposure:
- 4 h
- Observation period:
- up to 72 h
- Number of animals:
- 6
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- According to the results of the study the test substance showed no cutaneous reactions (after 1, 24, 48 and 72 hours) on the rabbits skin and can therefore be considered as not irritating to the skin.
Reference
Summary of results:
No cutaneous reaction was observed one hour, 24, 48 and 72 hours after the removal of the dressing. The scoring was at all times "0" concerning erythema and eschar formation as well as oedema formation.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Although info about the batch of the tested substance is delivered, no info about its purity is given; statement that study was performed in accordance with GLP guidelines but no provision of a certificate. The study was performed in accordance with an official guideline. The methodology, evaluation of the results and the results themselves are well documented.
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EEC appendix V B5
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: "New Zealand albino rabbits"
- Details on test animals or tissues and environmental conditions:
- Supplier of animals: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
Sex of animals: all male - Observation period (in vivo):
- 1, 24, 48 and 72 hours after introduction of the test substance
- Number of animals or in vitro replicates:
- 6
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: statement in the study report
- Conclusions:
- According to the result of the study the test substance is considered as non-irritant to the rabbits eye since the ocular reactions noted 1, 24 and 48 hours after the introduction were completely reversible after 72 hours.
Reference
Summary of results:
One hour after the introduction of the test substance, moderate conjunctival reactions and slight discharge were observed in all the animals. After 24 hours, the conjunctival reactions regressed and were slight in all the animals and minimal corneal opacity was noted in 2 animals. After 48 hours, only slight conjunctival lesions persisted in one animal. After 72 hours, no ocular reaction was noted.
Results:
One hour after introduction of the test substance, the following conjunctival reactions were observed:
- swelling more than normal in one animal
- obvious swelling with partial eversion of the eyelids in 5 animals
- definite hyperaemia of certain blood vessels in 2 animals
- diffuse crimson colouration of the blood vessels in 4 animals
- slight discharge in all the animals.
After 24 h, the conjunctival lesions regressed, the discharge was no longer noted and minimal corneal opacity appeared in 2 animals.
After 48 h, only swelling more than normal of the conjunctiva and definite hyperaemia of certain blood vessels were still noted in one animal.
After 72 h, the ocular reactions were no longer noted.
Table with summary of the results
Mean score per area | Observation time | |||
1 hour | 24 hours | 48 hours | 72 hours | |
Chemosis | 1.8 | 0.8 | 0.2 | 0 |
Redness of the conjunctiva | 1.7 | 1.2 | 0.2 | 0 |
Iris | 0 | 0 | 0 | 0 |
Corneal opacity | 0 | 0.3 | 0 | 0 |
Conclusion in the study report:
Under the experimental conditions of the present study, the test substance ACIDE P-TERTIOBUTYLBENZOIQUE is considered non-irritant.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The available data about skin irritation/corrosion and eye irritation suggest that 4 -tertbutyl benzoic acid is not irritating. There is no data available about respiratory irritation.
Justification for selection of skin irritation / corrosion endpoint:
Summary of data cited in reliable reference (European Union Risk Assessment Report - 4-TERT-BUTYLBENZOIC ACID- RISK ASSESSMENT
July 2009, FINAL APPROVED VERSION)
Justification for selection of eye irritation endpoint:
Summary of data cited in reliable reference (European Union Risk Assessment Report - 4-TERT-BUTYLBENZOIC ACID- RISK ASSESSMENT
July 2009, FINAL APPROVED VERSION)
Justification for classification or non-classification
Based on the available data on skin and eye irritation no corresponding signs of irritation were observed.
Reason for no classification: conclusive, but not sufficient for classification.
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