Registration Dossier
Registration Dossier
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EC number: 436-900-9 | CAS number: 39290-90-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
- 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:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 417 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12
- 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:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Terracess P is not classified for acute oral, dermal and inhalation toxicity and therefore, no acute DNELs have to be derived. The long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, Draft new chapter B.8 Scope of Exposure Assessment, March 2010).
DNELs for local effects will not be derived, as no local effects in repeated dose studies were observed.
The following DNELs for workers will be derived:
Systemic:
Long-term inhalation workers
Long-term dermal workers
Route-to-route extrapolation
For the derivation of the DNELs:
Long-term – dermal, systemic effects
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 50%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100%
The DNELs for human exposure are derived according to the ECETOC guidance (final draft March 17, 2010).
Starting point for DNEL derivation: NOAEL >= 1000 mg/kg bw/day from an oral 28 -day study, developmental toxicity study and 2 -generation toxicity study in rats. NOAEL >= 50 mg/m3 from an inhalation 90 -day study.
Long-term inhalation, systemic effects
Route-to-route extrapolation:
Corrected Inhalatory NOAEL = inhalatory NOAEL (50mg/m3) * 6 h/d / 8 h/d * 6.7 m3/10 m3= 25 mg/m3
Safety factors:
- Interspecies extrapolation: 1 (based on inhalation study)
- Intraspecies extrapolation: 3
- Exposure duration: 2 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 6
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker, is set at 4.2 mg/m3.
Long-term dermal, systemic effects
The oral and inhalation exposure toxicity studies can be used as starting point for derivation of the dermal DNEL. The skin is a comparable barrier to the intestines, while the skin is less comparable to the lungs. In addition, the lungs have a macrophage removal system for solids, which the intestines and skin don't have (much less). No metabolism occurs. Therefore, the oral studies are used as a starting point for route-to-route extrapolation.
Route-to-route extrapolation:
Corrected Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000 * 50/10 = 5000 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 3
- Exposure duration: 1 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 12
Based on the above, the long-term DNEL for systemic effects after dermal worker exposure is set at 417 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- 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:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 250 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- 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:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Terracess P is not classified for acute oral, dermal and inhalation toxicity and therefore, no acute DNELs have to be derived. The long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur (in accordance with ECHA Guidance on information requirements and chemical safety assessment: Chapter R.8: Characterisation of dose [concentration]-response for human health, May 2008 and Part B: Hazard Assessment, Draft new chapter B.8 Scope of Exposure Assessment, March 2010).
DNELs for local effects will not be derived, as no local effects in repeated dose studies were observed.
The following DNELs for the general population will be derived:
Systemic:
Long-term inhalation general population
Long-term dermal general population
Long-term oral general population
Route-to-route extrapolation
For the derivation of the DNELs:
Long-term – dermal, systemic effects
Route-to-route extrapolation has been performed. In absence of relevant data, only differences between the different routes as determined by the assumed percentages of absorption into the systemic circulation could be accounted for (see toxicokinetic assessment).
Absorption oral (rat) = Absorption oral (human) = 50%
Absorption dermal (human) = 10%
Absorption inhalation (human) = 100%
The DNELs for human exposure are derived according to the ECETOC guidance (final draft March 17, 2010).
Starting point for DNEL derivation: NOAEL >= 1000 mg/kg bw/day from an oral 28 -day study, developmental toxicity study and 2 -generation toxicity study in rats. NOAEL >= 50 mg/m3 from an inhalation 90 -day study in rats.
Long-term inhalation, systemic effects
Route-to-route extrapolation:
Corrected Inhalatory NOAEL = inhalatory NOAEL (50 mg/m3) * 6 h/d / 24 h/d = 12.5 mg/m3
Safety factors:
- Interspecies extrapolation: 1 (based on inhalation study)
- Intraspecies extrapolation: 5
- Exposure duration: 2 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 10
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the general population, is set at 1.25 mg/m3.
Long-term dermal, systemic effects
The oral and inhalation exposure toxicity studies can be used as starting point for derivation of the dermal DNEL. In none of the repeated dose studies adverse effects were observed, no metabolism occurs, and the barrier for oral and dermal absorption is more comparable than the barrier for respiratory and dermal absorption. Therefore, the oral studies are used as a starting point for route-to-route extrapolation.
Route-to-route extrapolation:
Corrected Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000 * 50/10 = 5000 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 1 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 20
Based on the above, the long-term DNEL for systemic effects after dermal general population exposure is set at 250 mg/kg bw/day.
Long-term oral, systemic effects
Starting point: oral NOAEL ≥1000 mg/kg bw/day
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 1 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 20
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population, is set at 50 mg/kg bw/day
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