Registration Dossier
Registration Dossier
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EC number: 281-161-6 | CAS number: 83877-91-2
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 254 mg/m³
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report No. 86
- Overall assessment factor (AF):
- 6
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Derivation of DNEL-workers
Hazard via inhalation route
Hazard assessment of the substance is based on the most hazardous degradation product, 2 -methylpropanol, since the target substance reacts in use applications and no reliable study is available from the substance itself.
NOAEC from rat subchronic inhalation study of 2 -methylpropanol is used to derive DNEL.
NOAEC = 1000 ppm (3030 mg/m3) for 2-methylpropanol; subchronic, inhalation, rat by Li, A. A. et al. (1999).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 1.
Route of exposure (inhalation vs inhalation); bioavailability is assumed to be 100 % in humans and in experimental animals
Corrected inhalatory NOAEC= inhalatory NOAEC * exp. time rat / exp. time worker * ABS rat / ABS human * sRVhuman 8h / wRV
ABS - absorption
sRVhuman - respiratory volume under standard conditions
wRV - respiratory volume light activity for worker
Corrected inhalatory NOAEC= 3 030 mg/m3* (6h/d / 8h/d) * (100/100) * (6,7m3/10m3) =1 523 mg/m3
Assessment factors – Based on ECETOC (2003) technical report No. 86
Intraspecies differences for worker = 3
Exposure duration - subchronic to chronic = 2
Overall AF = 3*2 = 6
DNEL worker systemic effects by inhalation= 1 523 mg/m3 / 6 = 254 mg/m3General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 303 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report No. 86
- Overall assessment factor (AF):
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 220 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report No. 86
- Overall assessment factor (AF):
- 40
- Explanation for the modification of the dose descriptor starting point:
- NOAEC from rat subchronic inhalation study of 2-methylpropanol is used to derive this DNEL since no dermal study is available from the substance or from the degradation product.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 22 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report No. 86
- Overall assessment factor (AF):
- 40
- Explanation for the modification of the dose descriptor starting point:
- NOAEC from rat subchronic inhalation study of 2-methylpropanol is used to derive this DNEL since no oral study is available from the substance or from the degradation product.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Derivation of DNEL-general population
Hazard via inhalation route
Hazard assessment of bis(ethylacetoacetato-O1’,O3”) bis(2 -methyl propan-1 -olato)titanium is based on the most hazardous degradation product, 2 -methylpropanol, since the target substance reacts in use applications and no reliable study is available from the substance itself.
NOAEC from rat subchronic inhalation study of 2 -methylpropanol, is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOAEC = 1 000 ppm (3 030 mg/m3) for 2-methylpropanol; subchronic, inhalation, rat by Li, A. A. et al. (1999).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 1.
Route of exposure (inhalation vs inhalation); bioavailability is assumed to be 100% in humans and in experimental animals. Exposure time is 6 h/day for rats and for humans.
Corrected inhalatory NOAEC= inhalatory NOAEC * exp. time rat / exp. time general population * ABS rat / ABS human
ABS - absorption
Corrected inhalatory NOAEC= 3 030 mg/m3* (6 h/d / 6 h/d) * (100/100) =3 030 mg/m3
Assessment factors – Based on ECETOC (2003) technical report No. 86
Intraspecies differences for general population = 5
Exposure duration - subchronic to chronic = 2
Overall AF = 5 x 2 = 10
DNEL general population chronic systemic by inhalation route = 3 030 mg/m3 / 10 = 303 mg/m3
-----------------------
Hazard via oral route
Hazard assessment of bis(ethylacetoacetato-O1’,O3”) bis(2-methyl propan-1-olato)titanium is based on the most hazardous degradation product, 2 -methylpropanol, since the target substance reacts in use applications and no reliable study is available from the substance itself.
NOAEC from rat subchronic inhalation study of2 -methylpropanol, is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOAEC = 1 000 ppm (3 030 mg/m3) for 2 -methylpropanol; subchronic, inhalation, rat by Li, A. A. et al. (1999).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 4.
Route of exposure (inhalation vs oral); bioavailability is assumed to be 100% in humans and in experimental animals
Corrected oral NOAEL = inhalatory NOAEC * sRV rat 6h * exp. time rat / exp. time general population * ABS inh-rat / ABS oral-human
ABS - absorption
sRV - standard respiratory volume
Corrected oral NOAEL= 3 030 mg/m3* 0.29 * (6 h/d / 6 h/d) * (100/100) =879 mg/kg bw/day
Assessment factors – Based on ECETOC (2003) technical report No. 86
Allometric scaling = 4
Intraspecies differences for general population = 5
Exposure duration - subchronic to chronic = 2
Overall AF = 4 x 5 x 2 = 40
DNEL general population chronic systemic by oral route = 879 mg/kg bw/day / 40 = 22 mg/kg bw/day
-----------------------
Hazard via dermal route
Hazard assessment of bis(ethylacetoacetato-O1’,O3”) bis(2-methyl propan-1-olato)titanium is based on the most hazardous degradation product, 2 -methylpropanol, since the target substance reacts in use applications and no reliable study is available from the substance itself.
NOAEC from rat subchronic inhalation study of 2 -methylpropanol, is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOAEC = 1 000 ppm (3030 mg/m3) for 2 -methylpropanol; subchronic, inhalation, rat by Li, A. A. et al. (1999).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 4.
100 % inhalation absorption regardless of species
10 % dermal absorption regardless of species
Corrected dermal NOAEL = inhalatory NOAEC * sRV rat 6h * exp. time rat / exp. time general population * ABS inh-rat / ABS dermal-human
ABS - absorption
sRV - standard respiratory volume
Corrected dermal NOAEL= 3030 mg/m3* 0.29 * (6 h/d / 6 h/d) * (100/10) = 8787 mg/kg bw/day
Assessment factors – Based on ECETOC (2003) technical report No. 86
Allometric scaling = 4
Intraspecies differences for general population = 5
Exposure duration - subchronic to chronic = 2
Overall AF = 4 x 5 x 2 = 40
DNEL general population chronic systemic by dermal route = 8787 mg/kg bw/day / 40 = 220 mg/kg bw/day
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