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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
3.5 mg/m³
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:
14 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.02 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Dose descriptor:
other: LOAEL
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

DNELs for acute exposure (local and systemic effects)

TBEP is not classified as hazardous for acute toxicity, neither is it classified as irritating to skin or eyes, or a sensitiser. According to REACH guidance Appendix R.8-8 is it therefore not necessary to derive acute DNEL values. There are no reported irritant or toxic effects relevant to high peak exposure. For <15 minutes exposures, a factor of three times the long-term DNEL can be used in line with the recommendations of

DNELs for long-term exposure (systemic effects)

Inhalation (systemic)

No repeat dose inhalation toxicity study is available for TBEP. The inhalation DNEL was calculated using the 18-week toxicity study by oral (dietary) route. The experimental NOAEC in this study was 300 ppm, corresponding to NOAEL approximately 20 mg/kg bw.

Modification of starting point:

The NOAEL (rat) 20 mg/kg was corrected to NOAEC (human) taking into account:
Bodyweight (human):   70 kg
Worker respiratory volume (wRV):10 m3
NOAEC (worker):140 mg/m3

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:
Route-to-route extrapolation:1(100% absorption considered for oral)
Interspecise variability (allometric scaling rat:human):     4
Interspecies variability (remaining differences):1(no indication to apply default 2.5)
Intraspecies variability:5(default value for workers)
Exposure duration:2(default value for subchronic to chronic)
Quality of whole database:1
Overall AF:40

Worker-DNEL long-term for inhalation route-systemic:   3.5 mg/m3

Dermal (systemic)

The dermal DNEL was calculated using the 21-day dermal toxicity study. The experimental NOAEL for systemic effects in this study was 1000 mg/kg bw/day.

Modification of starting point:

No modification from experimental NOAEL (rabbit) 1000 mg/kg was required
NOAEL (human):1000 mg/kg

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:
Route-to-route extrapolation:1(dermal route used, absorption rabbit & human assumed same)
Interspecies variation (allometric scaling rabbit:human): 2.4
Interspecies variability (remaining differences):1(no indication to apply default 2.5)
Intraspecies variability:5(default value for workers)
Exposure duration:6(default value for subacute to chronic)
Quality of whole database:1
Overall AF:72

Worker-DNEL long-term for dermal route-systemic: 14 mg/kg

 

DNELs for long-term exposure (local effects)

Inhalation (local)

No repeat dose inhalation toxicity study is available for TBEP. It is therefore not possible to calculate a DNEL for local effects on the respiratory system. Data on clinical effects in the acute inhalation toxicity studies indicate that exposure to 0.52 mg/l (520 mg/m3) for 4 hours resulted in minimal irritant effects (salivation, lacrimation). The worker-DNEL long-term for systemic effects by inhalation is 3.5 mg/m3. Since this DNEL is lower than the respiratory irritation threshold by a factor of 150, the long-term systemic DNEL is protective for local effects.

Worker-DNEL long-term for inhalation route-local: 3.5 mg/m3

 

Dermal (local)

The dermal DNEL was calculated using the 21-day dermal toxicity study. The experimental NOAEL for local dermal effects in this study was 10 mg/kg bw/day.

Modification of starting point:

The NOAEL (rabbit) 10 mg/kg was corrected to NOAEL (human) taking into account:
Experimental bodyweight (rabbit):        2.6 kg
Rabbit dermal surface area 2600 cm2
% body coverage: 10%
NOAEL (human):0.1 mg/cm2/day

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:
Route-to-route extrapolation:1(dermal route used, absorption rabbit & human assumed same)
Interspecies variability (remaining differences):1(no indication to apply default 2.5)
Intraspecies variability:5(default value for workers)
Exposure duration:1(effects concentration dependent)
Dose-response:1(NOAEC)
Quality of whole database:1
Overall AF:5

Worker-DNEL long-term for dermal route-local:   0.02 mg/cm2/day

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
1 mg/m³
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
1 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
1 mg/m³
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
144
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
7 mg/kg bw/day
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.01 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Dose descriptor:
other: LOAEL
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.01 mg/cm²

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
0.25 mg/kg bw/day
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNELs for acute exposure (local and systemic effects)

TBEP is not classified as hazardous for acute toxicity, neither is it classified as irritating to skin or eyes, or a sensitiser. According to REACH guidance Appendix R.8-8 is it therefore not necessary to derive acute DNEL values. Acute exposures are not anticipated for the general population.

DNELs for long-term exposure (systemic effects)

Inhalation (systemic)

No repeat dose inhalation toxicity study is available for TBEP. The inhalation DNEL was calculated using the 18-week toxicity study by oral (dietary) route. The experimental NOAEC in this study was 300 ppm, corresponding to NOAEL approximately 20 mg/kg bw.

Modification of starting point:

The NOAEL (rat) 20 mg/kg was corrected to NOAEC (human) taking into account:
Bodyweight (human):   70 kg
Human respiratory volume (sRV):20 m3 (worst case 24 h)
NOAEC (general population):70 mg/m3

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:
Route-to-route extrapolation:1(100% absorption considered for oral)
Interspecise variability (allometric scaling rat:human):     4
Interspecies variability (remaining differences):1(no indication to apply default 2.5)
Intraspecies variability:10(default value for general population)
Exposure duration:2(default value for subchronic to chronic)
Quality of whole database:1
Overall AF:80

General population-DNEL long-term for inhalation route-systemic:        1 mg/m3

Dermal (systemic)

The dermal DNEL was calculated using the 21-day dermal toxicity study. The experimental NOAEL for systemic effects in this study was 1000 mg/kg bw/day.

Modification of starting point:

No modification from experimental NOAEL (rabbit) 1000 mg/kg was required
NOAEL (human):1000 mg/kg

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:
Route-to-route extrapolation:1(dermal route used, absorption rabbit & human assumed same)
Interspecies variation (allometric scaling rabbit:human): 2.4
Interspecies variability (remaining differences):1(no indication to apply default 2.5)
Intraspecies variability:10(default value for general population)
Exposure duration:6(default value for subacute to chronic)
Quality of whole database:1
Overall AF:144

General population-DNEL long-term for dermal route-systemic: 7 mg/kg

Oral (systemic)

The oral DNEL was calculated using the 18-week toxicity study by oral (dietary) route. The experimental NOAEC in this study was 300 ppm, corresponding to NOAEL approximately 20 mg/kg bw.

Modification of starting point:

No modification from experimental NOAEL (rabbit) 20 mg/kg was required
NOAEL (human):20 mg/kg

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:
 Interspecies variation (allometric scaling rat:human):     4
Interspecies variability (remaining differences):1(no indication to apply default 2.5)
Intraspecies variability:10(default value for general population)
Exposure duration:2(default value for subchronic to chronic)
Quality of whole database:1
Overall AF:80

General population-DNEL long-term for oral route-systemic:      0.25 mg/kg

 

DNELs for long-term exposure (local effects)

Inhalation (local)

No repeat dose inhalation toxicity study is available for TBEP. It is therefore not possible to calculate a DNEL for local effects on the respiratory system. Data on clinical effects in the acute inhalation toxicity studies indicate that exposure to 0.52 mg/l (520 mg/m3) for 4 hours resulted in minimal irritant effects (salivation, lacrimation). The general population-DNEL long-term for systemic effects by inhalation is 1 mg/m3. Since this DNEL is lower than the respiratory irritation threshold by a factor of 500, the long-term systemic DNEL is protective for local effects.

General population-DNEL long-term for inhalation route-local: 1 mg/m3

 

Dermal (local)

The dermal DNEL was calculated using the 21-day dermal toxicity study. The experimental LOAEL for local dermal effects in this study was 10 mg/kg bw/day.

Modification of starting point:

The NOAEL (rabbit) 10 mg/kg was corrected to NOAEL (human) taking into account:
Experimental bodyweight (rabbit):        2.6 kg
Rabbit dermal surface area 2600 cm2
% body coverage: 10%
NOAEL (human):0.1 mg/cm2/day

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:
Route-to-route extrapolation:1(dermal route used, absorption rabbit & human assumed same)
Interspecies variability (remaining differences):1(no indication to apply default 2.5)
Intraspecies variability:10(default value for general population)
Exposure duration:1(effects concentration dependent)
Dose-response:1 (NOAEC)
Quality of whole database:1
Overall AF:10

General population-DNEL long-term for dermal route-local:        0.01 mg/cm2/day