Registration Dossier
Registration Dossier
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EC number: 227-006-8 | CAS number: 5593-70-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 127 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
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 titanium tetrabutanolate is based on the most hazardous degradation product, n-butanol, 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 n-butyl acetate, metabolic precursor of n-butanol, is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOAEC = 1 520 mg/m3for n-butyl acetate; subchronic, inhalation, rat by David, R.M. (2001).
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= 1 520 mg/m3* (6h/d / 8h/d) * (100/100) * (6,7m3/10m3) =764 mg/m3
Assessment factors – Based on ECETOC technical report No. 86
Intraspecies differences for workers 3
Exposure duration - subchronic to chronic 2
Overall AF 3*2 = 6
DNEL worker systemic effects by inhalation= 764 mg/m3 / 6 = 127 mg/
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 152 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
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:
- 37.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report No. 86
- Explanation for the modification of the dose descriptor starting point:
- NOAEL from rat subchronic oral study of n-butanol is used to derive DNEL since no dermal study is available from the substance.
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:
- 3.75 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC technical report No. 86
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 titanium tetrabutanolate is based on the most hazardous degradation product, n-butanol, 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 n-butyl acetate, metabolic precursor of n-butanol, is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOAEC = 1 520 mg/m3for n-butyl acetate; subchronic, inhalation, rat by David, R.M. (2001).
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 and exposure time 6 hours/day for rats and for general population.
Corrected inhalatory NOAEC= inhalatory NOAEC * exp. timerat/ exp. timegeneral population* ABSrat/ ABShuman
ABS - absorption
Corrected inhalatory NOAEC= 1 520 mg/m3* (6 h/d / 6 h/d) * (100 / 100) = 1 520 mg/m3
Assessment factors – Based on ECETOC technical report No. 86
Intraspecies differences – general population = 5
Exposure duration - subchronic to chronic = 2
Overall AF = 5*2 = 10
DNEL general population systemic effects by inhalation= 1 520 mg/m3/ 10 = 152 mg/m3
Hazard via oral route
Hazard assessment of titanium tetrabutanolate is based on the most hazardous degradation product, n-butanol, since the target substance reacts in use applications and no reliable study is available from the substance itself.
NOAEL from rat subchronic oral study of n-butanol is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOAEL = 150 mg/kg bw/day for n-butanol; subchronic, oral gavage, rat by Tompkins, C.E. (1995).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 2.
100% oral absorption regardless of species
Corrected oral NOAEL = oral NOAEL * (ABSrat / ABShuman)
Corrected oral NOAEL = 150 * (100/100)
Corrected oral NOAEL = 150 mg/kg bw/day
Assessment factors – Based on ECETOC technical report No. 86
Allometric scaling - rat 4
Intraspecies differences - general population 5
Exposure duration - subchronic to chronic 2
Overall AF 4 * 5 * 2 = 40
DNEL general population by oral route = 150 mg/kg bw/day / 40 = 3.75 mg/kg bw/day
Hazard via dermal route
Hazard assessment of titanium tetrabutanolate is based on the most hazardous degradation product, n-butanol, since the target substance reacts in the use applications and no dermal study is available from the substance itself.
NOAEL from rat subchronic oral study of n-butanol is used to derive DNEL.
Relevant dose descriptor for the endpoint
NOAEL = 150 mg/kg bw/day for n-butanol; subchronic, oral gavage, rat by Tompkins, C.E. (1995).
Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012). Example B. 5
100% oral absorption regardless of species
10% dermal absorption regardless of species
Corrected dermal NOAEL = oral NOAEL * (ABSoral-rat / ABSdermal-human)
Corrected dermal NOAEL = 150 mg/kg bw/day * (100/10)
Corrected dermal NOAEL = 1 500 mg/kg bw/day
Assessment factors – Based on ECETOC technical report No. 86
Allometric scaling -rat 4
Intraspecies differences - general population 5
Exposure duration - subchronic to chronic 2
Overall AF 4 * 5 * 2 = 40
DNEL general population by dermal route = 1 500 mg/kg bw/day / 40 = 37.5 mg/kg bw/day
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