Registration Dossier
Registration Dossier
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EC number: 478-900-1 | CAS number: 6156-18-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.96 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):
- 250
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 740 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 13-week toxicity study by oral administration (7 days per week) to rats (Bentz, 2015). The starting dose for DNEL calculation is a NOAEL of 300 mg/kg/day.
As the MW of BMTP is less than 500 g/mol and the log Kow is between 0 and 4, absorption by the oral and inhalation route was assumed to be equivalent (100%).
The NAEC (8h) derived for workers is 740.1 mg/m3 (300 mg/kg/d x 1/0.38 m3/kg x 6.7 m3/10 m3 x 7/5) after correction for difference between respiratory rates under standard conditions and under conditions of light activity and for workers exposure (5 days per week).
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 10
- Justification:
- An additional AF of 10 is used to take into account the difference of sensitivity of a repeated dose toxicity study compared to an EOGRTS (OECD 443) to assess for the reproductive / developmental toxicity
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:
- 0.84 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):
- 1 000
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 840 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 13-week toxicity study by oral administration (7 days per week) to rats (Bentz, 2015). The starting dose for DNEL calculation is a NOAEL of 300 mg/kg/day.
According to the available toxocological data, the dermal absorption of BMTP seems lower than the oral absorption. For the purpose of the DNEL derivation, the dermal absorption is estimated to be 50% of the oral absorption.
After correction for dermal absorption and for workers exposure (5 days per week) the NAEC is 840 mg/kg/d (300 mg/kg/d x 100/50 x 7/5).
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 10
- Justification:
- An additional AF of 10 is used to take into account the difference of sensitivity of a repeated dose toxicity study compared to an EOGRTS (OECD 443) to assess for the reproductive / developmental toxicity
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:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.522 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):
- 500
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 261 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 13-week toxicity study by oral administration (7 days per week) to rats (Bentz, 2015). The starting dose for DNEL calculation is a NOAEL of 300 mg/kg/day.
As the MW of BMTP is less than 500 g/mol and the log Kow is between 0 and 4, absorption by the oral and inhalation route was assumed to be equivalent.
The NAEC (8h) derived for the general population is 260.9 mg/m3 (300 mg/kg x 1/1.15 m3/kg).
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 10
- Justification:
- An additional AF of 10 is used to take into account the difference of sensitivity of a repeated dose toxicity study compared to an EOGRTS (OECD 443) to assess for the reproductive / developmental toxicity
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:
- 0.3 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):
- 2 000
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 600 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 13-week toxicity study by oral administration (7 days per week) to rats (Bentz, 2015). The starting dose for DNEL calculation is a NOAEL of 300 mg/kg/day.
According to the available toxocological data, the dermal absorption of BMTP seems lower than the oral absorption. For the purpose of the DNEL derivation, the dermal absorption is estimated to be 50% of the oral absorption.
After correction for dermal absorption and for workers exposure (5 days per week) the NAEC is 600 mg/kg/d (300 mg/kg/d x 100/50).
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 10
- Justification:
- An additional AF of 10 is used to take into account the difference of sensitivity of a repeated dose toxicity study compared to an EOGRTS (OECD 443) to assess for the reproductive / developmental toxicity
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:
- 0.15 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):
- 2 000
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 13-week toxicity study by oral administration (7 days per week) to rats (Bentz, 2015). The starting dose for DNEL calculation is a NOAEL of 300 mg/kg/day.
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 10
- Justification:
- An additional AF of 10 is used to take into account the difference of sensitivity of a repeated dose toxicity study compared to an EOGRTS (OECD 443) to assess for the reproductive / developmental toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
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.
