Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.9 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
BMDL05
Value:
55.2 mg/kg bw/day
Modified dose descriptor starting point:
BMCL05
Value:
136 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
1
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:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
470 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: TMBX DNEL calculated from methanol OEL
Dose descriptor starting point:
other: methanol OEL
Value:
260 mg/m³
Modified dose descriptor starting point:
other: TMBX OEL
Value:
470 mg/m³
Explanation for the modification of the dose descriptor starting point:

The OEL for methanol has been used to derive a DNEL of 470mg/m3 for TMBX, based upon the molar proportion of methanol present following the hydrolysis of TMBX predicted in physiological fluids.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
470 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: TMBX DNEL calculated from methanol OEL
Dose descriptor:
other: methanol OEL
Value:
260 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
470 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: TMBX DNEL derived from methanol OEL
Dose descriptor starting point:
other: methanol OEL
Value:
260 mg/m³

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
72.3 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: TMBX DNEL calculated from methanol OEL
Dose descriptor starting point:
other: OEL
Value:
260 mg/m³
Modified dose descriptor starting point:
other: methanol dermal systemic DNEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Exposure to 260 mg/m³ during a working shift is roughly equivalent to a dose of 2.6 g/person/day (40 mg/kg bw/ day) which may be considered as a systemic DNEL (40 mg/kg bw/day), too, if the dermal uptake is the same as from inhalation (which is a worst-case consideration neglecting also the high volatility of the material). The dermal systemic DNEL for methanol (40 mg/kg bw/day) has been used to derive a DNEL for TMBX, based upon the molar proportion of methanol present following the hydrolysis of TMBX predicted in physiological fluids.

Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
72.3 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: TMBX DNEL calculated from methanol OEL
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
other: methanol OEL
Value:
260 mg/m³
Modified dose descriptor starting point:
other: methanol dermal systemic DNEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Exposure to 260 mg/m³ during a working shift is roughly equivalent to a dose of 2.6 g/person/day (40 mg/kg bw/ day) which may be considered as a systemic DNEL (40 mg/kg bw/day), too, if the dermal uptake is the same as from inhalation (which is a worst-case consideration neglecting also the high volatility of the material). The dermal systemic DNEL for methanol (40 mg/kg bw/day) has been used to derive a DNEL for TMBX, based upon the molar proportion of methanol present following the hydrolysis of TMBX predicted in physiological fluids.

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:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high 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:
1.92 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
BMDL05
Value:
55.2 mg/kg bw/day
Modified dose descriptor starting point:
BMCL05
Value:
48 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
1
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:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
93.98 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: TMBX DNEL calculated from methanol OEL
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: methanol OEL
Value:
260 mg/m³
Modified dose descriptor starting point:
other: TMBX DNEL
Value:
470 mg/m³
Explanation for the modification of the dose descriptor starting point:

Exposure to 260 mg/m³ during a working shift is roughly equivalent to a dose of 2.6 g/person/day (40 mg/kg bw/ day) which may be considered as a systemic DNEL (40 mg/kg bw/day), too, if the dermal uptake is the same as from inhalation (which is a worst-case consideration neglecting also the high volatility of the material). The dermal systemic DNEL for methanol (40 mg/kg bw/day) has been used to derive a DNEL for TMBX, based upon the molar proportion of methanol present following the hydrolysis of TMBX predicted in physiological fluids.

AF for intraspecies differences:
5
Justification:
An uncertainty factor of 5 was applied for the differences between worker exposure and the general population.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
93.98 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: TMBX OEL calculated from methanol OEL
Overall assessment factor (AF):
5
Dose descriptor:
other: Methanol OEL
Value:
260 mg/m³
AF for intraspecies differences:
5
Justification:
An uncertainty factor of 5 was applied for the differences between worker exposure and the general population.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
93.98 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: TMBX OEL calculated from methanol OEL
Overall assessment factor (AF):
5
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
other: Methanol OEL
Value:
260 mg/m³
AF for intraspecies differences:
5
Justification:
An uncertainty factor of 5 was applied for the differences between worker exposure and the general population.

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.5 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: TMBX DNEL calculated from methanol OEL
Overall assessment factor (AF):
5
Dose descriptor starting point:
other: Methanol OEL
Value:
260 mg/m³
Modified dose descriptor starting point:
other: Methanol dermal systemic DNEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Exposure to 260 mg/m³ during a working shift is roughly equivalent to a dose of 2.6 g/person/day (40 mg/kg bw/ day) which may be considered as a systemic DNEL (40 mg/kg bw/day), too, if the dermal uptake is the same as from inhalation (which is a worst-case consideration neglecting also the high volatility of the material). The dermal systemic DNEL for methanol (40 mg/kg bw/day) has been used to derive a DNEL for TMBX, based upon the molar proportion of methanol present following the hydrolysis of TMBX predicted in physiological fluids.

AF for intraspecies differences:
5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.5 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: TMBX DNEL calculated from methanol OEL
Overall assessment factor (AF):
5
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
other: Methanol OEL
Value:
260 mg/m³
Modified dose descriptor starting point:
other: Methanol dermal systemic DNEL
Value:
40 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Exposure to 260 mg/m³ during a working shift is roughly equivalent to a dose of 2.6 g/person/day (40 mg/kg bw/ day) which may be considered as a systemic DNEL (40 mg/kg bw/day), too, if the dermal uptake is the same as from inhalation (which is a worst-case consideration neglecting also the high volatility of the material). The dermal systemic DNEL for methanol (40 mg/kg bw/day) has been used to derive a DNEL for TMBX, based upon the molar proportion of methanol present following the hydrolysis of TMBX predicted in physiological fluids.

AF for intraspecies differences:
5

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.552 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
BMDL05
Value:
55.2 mg/kg bw/day
Value:
55.2 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
1
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:
1
Justification:
Default (DNEL calculator)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.552 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
BMDL05
Value:
55.2 mg/kg bw/day
Modified dose descriptor starting point:
BMDL05
Value:
55.2 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification of the ponit of departure is required as considering the same route of exposure

AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population