Registration Dossier
Registration Dossier
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EC number: 407-430-1 | CAS number: 3741-80-8 CP22595; SANTOCURE TBS1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 38.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- 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 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:
- 10.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- 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:
- 1.06 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 12.5
- Dose descriptor:
- other: NOAEL
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
Calculation dermal DNEL long-term, systemic
The subchronic oral toxicity test (Bechtel, 1990) conducted in male and female Sprague-Dawley rats was used as a starting point for the DNEL derivation.
90d NOAEL (rat) = 1093 mg/kg bw.d
workers NOAEL - dermal (human): (1093 mg/kg bw.d : (4 * 25)) = 109.3 mg/kg bw.d
Assessment factors as described above. ECHA assessment factors were used.
Calculation inhalation DNEL long-term, systemic
The subchronic oral toxicity test (Bechtel, 1990) conducted in male and female Sprague-Dawley rats was used as a starting point for the DNEL derivation.
90d NOAEL (rat) = 1093 mg/kg bw.d
workers NOAEC - inhalation: (1093 mg/kg bw.d : 0.38 m3/kg bw)*(6.7 m3 : 10 m3) = 1927.1 mg/m3
Assessment factors as described above. ECHA assessment factors were used.
Calculation dermal DNEL long-term, local
The subacute dermal toxicity test (21d) conducted in male and female rabbits (read-across from TBBS) was used as a starting point for the DNEL derivation.
21d NOAEL (rabbit) = 500 mg / kg bw (read-across from TBBS)
correction to appropriate unit:
* mean weight (males and females, throughout whole study): ca. 2,650 kg
* exposed area: 10 x 10 cm = 100 cm2
corrected NOAEL = 13,25 mg/cm2
Assessment factors as described above. ECHA assessment factors were used.
No time-scaling nor assessment factor required for duration of exposure due to the fact that local skin effects typically are mainly concentration-driven. No allometric scaling required for local effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- 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 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:
- 5.47 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.53 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- other: NOAEL
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:
- 5.46 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
Calculation dermal DNEL long-term, systemic
The subchronic oral toxicity test (Bechtel, 1990) conducted in male and female Sprague-Dawley rats was used as a starting point for the DNEL derivation.
90d NOAEL (rat) = 1093 mg/kg bw.d
general population NOAEL - dermal (human): (1093 mg/kg bw.d : (4 * 2.5)) = 109.3 mg/kg bw.d
Assessment factors as described above. ECHA assessment factors were used.
Calculation inhalation DNEL long-term, systemic
The subchronic oral toxicity test (Bechtel, 1990) conducted in male and female Sprague-Dawley rats was used as a starting point for the DNEL derivation.
90d NOAEL (rat) = 1093 mg/kg bw.d
general population NOAEC - inhalation: (1093 mg/kg bw.d : 1.15 m3/kg bw) = 950.4 mg/m3
Assessment factors as described above. ECHA assessment factors were used.
Calculation oral DNEL long-term, systemic
The subchronic oral toxicity test (Bechtel, 1990) conducted in male and female Sprague-Dawley rats was used as a starting point for the DNEL derivation.
90d NOAEL (rat) = 1093 mg/kg bw.d
No modification of starting point required. Inter-species extrapolation: rat-human; (4 * 2.5 = 10)
general population NOAEL - oral (human): (1093 mg/ kg bw.d : (4 * 2,5)) = 109.3 mg/kg bw.d
Assessment factors as described above. ECHA assessment factors were used.
Calculation dermal DNEL long-term, local
The subacute dermal toxicity test (21d) conducted in male and female rabbits (read-across from TBBS) was used as a starting point for the DNEL derivation.
21d NOAEL (rabbit) = 500 mg / kg bw (read-across from TBBS)
correction to appropriate unit:
* mean weight (males and females, throughout whole study): ca. 2,650 kg
* exposed area: 10 x 10 cm = 100 cm2
corrected NOAEL = 13,25 mg/cm2
Assessment factors as described above. ECHA assessment factors were used.
No time-scaling nor assessment factor required for duration of exposure due to the fact that local skin effects typically are mainly concentration-driven. No allometric scaling required for local effects.
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