Registration Dossier
Registration Dossier
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EC number: 949-820-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18.9 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Upper limit calculation by SCF/EFSA
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- NOAEL
- Value:
- 7.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 37.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The relevant dose descriptor selected to derive the inhalation DNEL, was the oral NOAEL of 540 mg/day or 7.7 mg/kg bw/day for a 70 Kg adult, which was used by SCF for the tolerable upper limit calculation. The NOAEL was derived from a double-blind placebo-controlled study which was designed to assess the effects of dl-α-tocopherol on general health, nutrient status, liver enzyme function, thyroid hormone concentrations, creatinine concentrations, serum autoantibodies, cytotoxic ability of neutrophils against Candida albicans, and bleeding time, in 88 healthy male and female subjects aged 65 years and older. This dose descriptor, which is the starting point was corrected for route-to-route extrapolation:
[i.e., NOAEL oral human ÷ SRvhuman-24h x (SRvhuman-24h ÷ SRvhuman-8h) x (SRvhuman-8h ÷ WSRvhuman-8h) x (ABSoral-human/ABSinh-human) x days per week(experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral human = 7.7 mg/kg bw/d; SRvhuman-24h = 20 m3/person (i.e., ca. 0.286 m3/kg bw); SRvhuman-8h = 6.7 m3/person (i.e., ca. 0.096 m3/kg bw); WSRvhuman-8h = 10 m3/person (i.e., ca. 0.143 m3/kg bw); ABSoral-human = 50%; ABSinh-human = 100%; days per week (experimental) = 7 days; days per week (human population) = 5 days for workers) = 7.7 x 1/0.286 x 0.286/0.096 x 0.096/0.143 x 7/5 x 50/100 (i.e., 7.7/0.143 x 7/5 x 50/100) = 37.8 mg/m3]
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- A larger uncertainty factor was not considered necessary because data from a number of other older but less well controlled studies showed no adverse effects at considerably higher intakes.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Based on human study
- AF for other interspecies differences:
- 1
- Justification:
- Based on human study
- AF for intraspecies differences:
- 2
- Justification:
- Intraspecies variation
- AF for the quality of the whole database:
- 1
- Justification:
- A larger uncertainty factor was not considered necessary because data from a number of other older but less well controlled studies showed no adverse effects at considerably higher intakes.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional factors are required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
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:
- 5.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: Upper limit calculation by SCF/EFSA
- Overall assessment factor (AF):
- 2
- Dose descriptor starting point:
- NOAEL
- Value:
- 9 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The relevant dose descriptor selected to derive the dermal DNEL, was the oral NOAEL of 540 mg/day or 7.7 mg/kg bw/day for a 70 Kg adult, which was used by SCF for the tolerable upper limit calculation. The NOAEL was derived from a double-blind placebo-controlled study which was designed to assess the effects of dl-α-tocopherol on general health, nutrient status, liver enzyme function, thyroid hormone concentrations, creatinine concentrations, serum autoantibodies, cytotoxic ability of neutrophils against Candida albicans, and bleeding time, in 88 healthy male and female subjects aged 65 years and older. This dose descriptor, which is the starting point was corrected for route-to-route extrapolation:
[i.e., NOAEL oral human x (ABSoral-human/ABSderm-human) x days per week(experimental)/days per week (human population] in accordance with REACH guidance document R.8 (‘Characterization of dose (concentration)-response for human health’) November (2012); where: NOAELoral human = 7.7 mg/kg bw/d; ABSoral-human = 50%; ABSderm-human = 50%; days per week (experimental) = 7 days; days per week (human population) = 5 days for workers) = 7.7 x 7/5 x 50/50 = 10.8 mg/kg bw/day]
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- A larger uncertainty factor was not considered necessary because data from a number of other older but less well controlled studies showed no adverse effects at considerably higher intakes.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Based on human study
- AF for other interspecies differences:
- 1
- Justification:
- Based on human study
- AF for intraspecies differences:
- 2
- Justification:
- Intra-species variation
- AF for the quality of the whole database:
- 1
- Justification:
- A larger uncertainty factor was not considered necessary because data from a number of other older but less well controlled studies showed no adverse effects at considerably higher intakes.
- AF for remaining uncertainties:
- 1
- Justification:
- No additional factors are required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Due to intermediate use of the test substance, no DNELs for general population has been derived.
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