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Diss Factsheets
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EC number: 231-710-0 | CAS number: 7695-91-2
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 73.5 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-threshold effect and/or no dose-response information available
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:
- 416.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
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
Additional information - workers
DNEL acute
A DNELacuteshould be established for substances if an acute hazard toxicity (leading to C&L) has been identified and a potential for high peak exposures exists.
DL-Alpha-Tocopheryl acetate does not have to be labelled for acute toxicity and therefore, a derivation of a DNELacute is not necessary.
DNEL long-term systemic
DL-Alpha-Tocopheryl acetate is not classified for any toxicological endpoint. For the DNEL-derivation a NOAEL of 500 mg/kg bw was used derived from the 90-day repeated dose oral, based on hemorrhagic diathesis in males and females (an increase in APTT, PT and fibrinogen at 2000 mg/kg).
The dermal DNEL for long-term exposure - systemic effects for workers is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 500 mg/kg bw/day |
Based on hemorrhagic diathesis in males and females |
Step 2) Modification of starting point |
x100/5
|
100% for oral absorption, and 5% absorption is assumed for dermal absorption |
Modified dose-descriptor |
500 x 100/5 = 10000 mg/kg bw/day |
|
Step 3) Assessment factors |
|
|
Interspecies |
4
|
Allometric scaling for the rat, the additional factor of 2.5 is omitted. |
Intraspecies |
3* |
Default assessment factor |
Exposure duration |
2 |
A correction for duration from sub-chronic to chronic is required |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
*DNEL using ECETOC AF |
10000/ (4 x 3 x 2 x 1 x 1)= 416.6 mg/kg bw/day |
The inhalation DNEL for long-term exposure - systemic effects for workers is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 500 mg/kg bw/day |
Based on hemorrhagic diathesis in males and females |
Step 2) Modification of starting point |
/0.38 m3/kg bw
x 6.7 m3/10 m3
x50/100
|
8 h respiratory volume for rat.
Correction for activity driven differences of respiratory volumes in workers compared to workers in rest.
Default 50% for oral absorption, and 100% absorption is assumed for inhalation. |
Modified dose-descriptor |
500 x 0.67 x 0.5 / 0.38 = 440 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
1.0
|
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation. The additional factor of 2.5 is omitted. |
Intraspecies |
3* |
Default assessment factor |
Exposure duration |
2 |
A correction for duration from sub-chronic to chronic is required |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
*DNEL using ECETOC AF |
440/ (1.0 x 3 x 2 x 1 x 1)= 73.5 mg/m3 |
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
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):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
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:
- 12.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
DNEL acute
A DNELacuteshould be established for substances if an acute hazard toxicity (leading to C&L) has been identified and a potential for high peak exposures exists.
DL-Alpha-Tocopheryl acetate
does not have to be labelled for acute toxicity and therefore, a derivation of a DNELacuteis not necessary.
DNEL long-term systemic
Vitamin acetate (isomer) is not classified for any toxicological endpoint.For the DNEL-derivation a NOAEL of 500 mg/kg bw was used derived from the 90-day repeated dose oral, based on hemorrhagic diathesis in males and females (an increase in APTT, PT and fibrinogen at 2000 mg/kg).
The dermal DNEL for long-term exposure - systemic effects for general population is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 500 mg/kg bw/day |
Based on hemorrhagic diathesis |
Step 2) Modification of starting point |
x100/5
|
100% for oral absorption and 5% absorption is assumed for dermal absorption. |
Modified dose-descriptor |
500 x 100/5 = 10000 mg/kg bw/day |
|
Step 3) Assessment factors |
|
|
Interspecies |
4
|
Allometric scaling for the rat, the additional factor of 2.5 is omitted. |
Intraspecies |
5* |
Default assessment factor |
Exposure duration |
2 |
A correction for duration from sub-chronic to chronic is required |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
*DNEL using ECETOC AF |
10000/ (4 x 5 x 2 x 1 x 1)= 250 mg/kg bw/day |
The inhalation DNEL for long-term exposure - systemic effects for general population is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 500 mg/kg bw/day |
Based on hemorrhagic diathesis |
Step 2) Modification of starting point |
/ 1.15 m3/kg bw
x 50/100
|
24 h respiratory volume for rats.
50% for oral absorption and 100% absorption is assumed for inhalation. |
Modified dose-descriptor |
500 / 1.15 x 0.5 = 217 mg/m3 |
|
Step 3) Assessment factors |
|
|
Interspecies |
1.0
|
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation. The additional factor of 2.5 is omitted. |
Intraspecies |
5* |
Default assessment factor |
Exposure duration |
2 |
A correction for duration from sub-chronic to chronic is required. |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
*DNEL using ECETOC AF |
217/ (1.0 x 5 x 2 x 1 x 1)= 21.7 mg/m3 |
The oral DNEL for long-term exposure - systemic effects for general public is derived as follows:
Description |
Value |
Remark |
Step 1) Relevant dose-descriptor |
NOAEL: 500 mg/kg bw/day |
Based on hemorrhagic diathesis |
Step 2) Modification of starting point |
Not required
|
|
|
|
|
Step 3) Assessment factors |
|
|
Interspecies |
4
|
Allometric scaling for the rat, the additional factor of 2.5 is omitted. |
Intraspecies |
5* |
Default assessment factor |
Exposure duration |
2 |
A correction for duration from sub-chronic to chronic is required |
Dose response |
1 |
|
Quality of database |
1 |
|
DNEL |
Value |
|
*DNEL using ECETOC AF |
500/ (4 x 5 x 2 x 1 x 1)= 12.5 mg/kg bw/day |
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.