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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 232-465-2 | CAS number: 8047-99-2
- 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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 19.1 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 114.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Selected starting point is a NOAEL of 1000 ppm from a dietary admixture study, which is equivalent to 52 -78
(average 65) mg/kg bw/day for males and 75 -161 mg/kg bw/day for females. The corrected 8 hr inhalation NOAEC for workers is NOAEL (65 mg/kg) * 1.76 mg/m3 = 114.6 mg/m3.
No factor 2 route extrapolation from oral to inhalation.
Kinetic studies indicate a rapid and complete absorption via oral route, and also via inhalation 100% absorption is assumed.
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor for sub-chronic to chronic extrapolation (AF 2)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already included in NOAEC calculation
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 3 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties are identified.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 325 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Selected starting point is a NOAEL of 1000 ppm from a dietary admixture study, equivalent to 65 mg/kg bw/day. Kinetic studies indicate a rapid and complete absorption via oral route, but dermal absorption is maximal 20%. The corrected dermal NOAEL for workers is NOAELoral (65 mg/kg) / 20% = 325 mg/kgbw/day.
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor for sub-chronic to chronic extrapolation (AF 2)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 3 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties are identified.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The toxicological profile of p-TSA only indicates a hazard for systemic toxicity following repeated dosing. The NOAEL selection of 65 mg/kg bw/day from a 2-generation study is possibly over-conservative. The only observed effect at the next, 3-times higher, dose level is a small effect on body weight. 90-day studies in rat and dog result to a NOAEL of around 250 mg/kg. However, the Japanese OECD 422 study resulted to a NAOEL of < 120 mg/kg related to an observed slightly thickened urinary bladder epithelium in some of the animals treated at this dose level, which is considered to be reversible and mediated by the peak-dose kinetics following dosing by gavage. All relevant inhalation and dermal exposure scenarios will not lead to similar tubular kidney concentrations causing such effects following the high oral bolus dosing by gavage.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.65 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 56.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Selected starting point is a NOAEL of 1000 ppm from a dietary admixture study, equivalent to 65 mg/kg bw/day.
The corrected 8 hr inhalation NOAEC for workers is NOAEL (65 mg/kg) * 1/1.15 mg/m3 = 56.5 mg/m3. No factor 2 route extrapolation from oral to inhalation. Kinetic studies indicate a rapid and complete absorption via oral route, and also via inhalation 100% absorption is assumed.
NOAEL for DNEL derivation = 65 mg/kg bw/day
The substance fulfils the REACH Annex VII to Annex X information requirements in accordance with ECHA guidance R7.5-7.7 (2017) for assessing long-term systemic toxicity. DNEL derivation for the inhalation route is considered necessary. In absence of inhalation toxicity data the NOAEL from the oral repeated dose toxicity study is used for derivation of the long-term DNEL for the inhalation route. The key study is considered to be the OECD TG 416 / GLP rat study. The NOAEL (No Observed Adverse Effect Level) for general toxicity was considered to be nominal dose level of 1000 ppm in males (65 mg/kg bw/day), based on decreased body weights and body weight gain, and due to this organ weight changes in both F0 and F1 parental animals.
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor for sub-chronic to chronic extrapolation (AF 2)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Already included in NOAEC calculation
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties are identified.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 325 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Selected starting point is a NOAEL of 1000 ppm from a dietary admixture study, equivalent to 65 mg/kg bw/day.
Kinetic studies indicate a rapid and complete absorption via oral route, but dermal absorption is maximal 20%. The corrected dermal NOAEL for general population is NOAELoral (65 mg/kg) / 20% = 325 mg/kgbw/day.
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor for sub-chronic to chronic extrapolation (AF 2)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties are identified.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 65 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Not applicable.
- AF for dose response relationship:
- 1
- Justification:
- No specific concerns; starting point is NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- The default assessment factor for sub-chronic to chronic extrapolation (AF 2)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)
- AF for the quality of the whole database:
- 1
- Justification:
- Available data derived from valid studies showing consistent results.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional uncertainties are identified.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
These substances are mainly applied in professional or industrial settings. Consequently, consumers/general population will generally not be exposed. The only identified consumer use concerns use as ingredient present (less than 1%) in adhesives/sealants used for gluing textile layers under an iron. This consumer use result to possibly some evaporation of p-TSA available in the sealant. In view of the low vp and the likely incidental consumer use, no significant exposures can be expected. In order to be able to evaluate possible secondary exposures via environment, the long-term systemic DNELs for general population have been derived.
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.