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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
6.61 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):
12
Dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
AF for differences in duration of exposure:
0.75
Justification:
0.75 is used to convert from 6 hr to 8 hr daily exposure and 0.67 for respiration for light work.
AF for interspecies differences (allometric scaling):
4
Justification:
ECETOC value
AF for intraspecies differences:
3
Justification:
ECETOC value
Justification:
subchronic to chronic dosing
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:
7.03 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
AF for other interspecies differences:
4
AF for intraspecies differences:
3
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Value:
35 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
9
Modified dose descriptor starting point:
other:

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

Workers

Acute oral exposure

Chapter 8 of the reach TGD (Appendix R.8 -8) indicates that acute exposure DNEL values are not normally required. However, acute oral toxicity studies in mice indicated that while the LD50 was estimated at 1800 mg/kg, a NOEL was established at 316 mg/kg. Using and adjustment factor of 3 for interspecies differences and an adjustment factor of 3 for intraspecies differences, a DNEL of 35 mg/kg was calculated. It is assumed also that there will be limited acute or long-term oral exposures to TMPD in worker populations. Additionally, the lack of dermal toxicity would indicate that TMPD is non-hazardous under acute exposure scenarios. Eye and respiratory irritation thresholds are assumed to exceed thresholds for chronic systemic effects.                            

Long-term inhalation, systemic

A 90-day repeat dose oral toxicity study gave a NOAEL of 120 mg/kg. The NOEL first must be converted to mg/m3 by dividing by a factor of 0.38, and then corrected for oral bioavailability (50%) by multiplying by a factor of 0.5. Further corrections are then necessary to convert from the 6 hour daily exposure to an 8 hour per day exposure (0.75), and to adjusted for respiration for light work (0.67). ECETOC Assessment factors were applied, for intraspecies (3), for interspecies (4), for a total of 12.     

- Converting mg/kg to mg/m3 = 120/0.38 = 315.78 mg/m3

- Correcting for oral bioavailability = 315.78*0.5 = 157.89 mg/m3

- Correcting for 7-day experimental exposure to 5-day work week, and light work= 157.89 mg/m3* (0.75) *(0.67) = 79.34 mg/m3

- Application of adjustment factors: 79.33 mg/m3/12= 6.61 mg/m3

Long-term dermal, systemic

A 90 -day repeat dose oral toxicity study gave a NOAEL of 120 mg/kg. The NOAEL first must be corrected to convert from the 6 hour daily exposure to an 8 hour per day exposure (0.75), and correction for 7-day experimental exposure to 5-day work week (1.4) and to adjusted for respiration for light work (0.67). ECETOC Assessment factors were applied, which consisted for intraspecies (3), for interspecies (4), for a total of 12.

- Correcting for 7-day experimental exposure to 5-day work week, and light work = 120 mg/kg*(1.4)*(0.67)*(0.75) = 84.42 mg/kg

- Application of adjustment factors: 84.42 mg/kg/12 = 7.03 mg/kg

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEC
AF for other interspecies differences:
4
AF for intraspecies differences:
5
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

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:
6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
AF for other interspecies differences:
5
AF for intraspecies differences:
4
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:
6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

General Population

Acute oral exposure

Chapter 8 of the reach TGD (Appendix R.8 -8) indicates that acute exposure DNEL values are not normally required. However, acute oral toxicity studies in mice indicated that while the LD50 was estimated at 1800 mg/kg, a NOEL was established at 316 mg/kg. Using and adjustment factor of 3 for interspecies differences and an adjustment factor of 3 for intraspecies differences and a factor of 2 for the general population, a DNEL of 18 mg/kg was calculated. It is assumed also that there will be limited acute or long-term oral exposures to TMPD in the general populations. Additionally, the lack of dermal toxicity would indicate that TMPD is non-hazardous under acute exposure scenarios. Eye and respiratory irritation thresholds are assumed to exceed thresholds for chronic systemic effcts.

Long-term inhalation, systemic

A 90 day repeat dose oral toxicity study gave a NOAEL of 120 mg/kg.  The NOAEL first must be converted to mg/m3by dividing by a factor of 1.15, and then corrected for oral bioavailability (50%) by multiplying by a factor of 0.5. ECETOC Assessment factors were applied, which consisted for intraspecies (5), for interspecies (4), for a total of 20.   

 - Converting mg/kg to mg/m3= 120/1.15 = 104.34 mg/m3

- Correcting for oral bioavailability = 120 *0.5 = 52.17 mg/m3

- Application of adjustment factors – 52.17 mg/m3/20 = 2 .6 mg/m3

Long-term dermal, systemic

A 90-day repeat dose oral toxicity study gave a NOAEL of 120 mg/kg.  ECETOC Assessment factors were applied, which consisted for intraspecies (5), for interspecies (4), for a total of 20.

- Application of adjustment factors: 120 mg/kg/20 = 6.0 mg/kg

Long-term oral, systemic

A 90-day repeat dose oral toxicity study gave a NOAEL of 120 mg/kg. ECETOC Assessment factors were applied, which consisted for intraspecies (5), for interspecies (4), for a total of 20.

- Application of adjustment factors: 120 mg/kg/20 = 6.0 mg/kg