Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 915-672-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No specific toxicokinetic data available, thus according to ECHA guidance 50% oral absorption in rat is assumed as well as 100% by inhalation.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- This factor describes the differences in metabolic rate between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor to accounts for remaining differences (e.g. toxicodynamics)
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties, NOAEL is already based on worst case assumptions.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 167 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
For the read-across substance TMPTA a NOAEL of 300 mg/kg bw/day was identified from an oral rat OECD 422 study.
The corrected dermal NOAEL = NOAEL (oral) x ABS (rat - oral)/ABS (derm - human) as given in ECHA guidance R8, example B.5.
Assuming an oral absorption of 100% (rat) and using testing data (0.6%) from an in vitro human dermal absorption study (see section 7.1.2) the corrected dermal NOAEL is NOAEL = 300 mg/kg bw/day x 100%/0.6% = 50000 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- This factor describes the differences in metabolic rate between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor to accounts for remaining differences (e.g. toxicodynamics)
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- Limited relevance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The following DNEL values for workers have been derived:
DNEL (inhalation, long-term systemic effects): 3.5 mg/m3
DNEL (inhalation, long-term local effects effects): no adequate data aviallable
DNEL (dermal, long-term systemic effect): 167 mg/kg bw/d
DNEL (dermal, long-term local effects): skin sensitiser/ irritant
DNEL (dermal, short term local effects): skin sensitiser
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.87 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 130 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No specific toxicokinetic data available, thus according to ECHA guidance 50% oral absorption in rat is assumed as well as 100% by inhalation
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- No extrapolation needed
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- This factor describes the differences in metabolic rate between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor to accounts for remaining differences (e.g. toxicodynamics)
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties, NOAEL is already based on worst case assumptions.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 83 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
For the read-across substance TMPTA a NOAEL of 300 mg/kg bw/day was identified from an oral rat OECD 422 study.
The corrected dermal NOAEL = NOAEL (oral) x ABS (rat-oral)/ABS (derm - human) as given in ECHA guidance R8, example B.5.
Assuming an oral absorption of 100% (rat) and using testing data (0.6%) from an in vitro human dermal absorption study (see section 7.1.2) the corrected dermal NOAEL is
NOAEL = 300 mg/kg bw/day x 100%/0.6% = 50000 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- This factor describes the differences in metabolic rate between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor to accounts for remaining differences (e.g. toxicodynamics)
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- DNEL for repeated dermal exposure in relation to systemic effects is of limited relevance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
Assume same oral absorption rate in rat and human
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- No extrapolation needed
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- This factor describes the differences in metabolic rate between mice and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor to accounts for remaining differences (e.g. toxicodynamics)
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties, NOAEL is already based on worst case assumptions.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
The following DNEL values for the general population have been derived:
DNEL (inhalation, long-term systemic effects): 0.87 mg/m3
DNEL (inhalation, long-term local effects effects): no adequate data aviallable
DNEL (dermal, long-term systemic effect): 83 mg/kg /d
DNEL (dermal, long-term local effects): skin sensitiser/ irritant
DNEL (dermal, short term local effects): skin senstiser
DNEL (oral, long-term, systemic effects): 0.5 mg/kg /d
DNEL (oral, short term local effects): No hazard identified
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