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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 201-228-5 | CAS number: 79-81-2
- 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
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
According to the REACH “Guidance on information requirements and chemical safety assessment”, a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
Vitamin A is a micronutrient essential for most mammalian species. The term “Vitamin A” is used as a generic descriptor for compounds, that exhibit the biological properties of retinol or other closely related naturally occurring derivatives. Vitamin A occurs in nature primarily as retinyl esters (retinyl palmitate, retinyl aceate and retinyl propionate) and retinol. It is an essential factor for the growth and maintenance of higher organisms.
The tolerable upper intake level for preformed vitamin A (Retinol and retinyl esters) is set at 3000 RE/day or approx. 10000 IU/day for adults (Scientific opinion EFSA, 2008). The recommended daily intake of Vitamin A for humans is approximately 0.6–1.0 mg RE/day (2000–3300 IU/day) for men, and 0.5-0.8 mg RE/day (1670–2660 IU/day) for women, depending on their age and reproductive status (WHO, EFSA, IARC). Since either a deficiency in Vitamin A exposure lead to adverse effects such as developmental toxicity, the derivation of a DNEL should take into account such levels. However, the classical approach, i.e. a DNEL derivation from the basis of no adverse effect levels by using standart assessment factors might not be applicable, since conservative use of assessment factors can lead to DNELs below recommended daily intake levels, beeing adverse per se. On the basis of the derived tolerable upper intake level for preformed vitamin A, a internal systemic safe level for retinyl palmitate in workers is set at 0.078 mg/ kg bw/d.
1 mg Retinyl palmitate = 550 RE
Derived tolerable upper intake level = 3000 RE/day
Derived tolerable upper intake level - retinyl palmitate = 1x3000/550 = 5.455 mg/day
Systemic safe level - retinyl palmitate = 5.455/70 = 0.078 mg/kg bw/d
In a weight of evidence from the available data on toxicokinetics, the dermal absorption rate for humans is set at 5% of the applied dose. Considering the comparative assessment of oral versus dermal administration observed by Nohyek et al, 2006, the oral absorption is expected to be extensively higher (up to 15 fold increases), which substantiates the assumption of a 100% oral absorption of retinyl palmitate.
For derivation of the long-term systemic dermal DNEL, the internal systemic safe level was converted in line with the procedure for route to route extrapolation, recommended in the current guidance document (R8, ECHA 2008):
Long-term systemic dermal DNEL = 0.078 *(100/5)= 1.6 mg/kg bw/d
No DNELs were derived for local effects after short term or after long term inhalative exposure as the substance exhibits no hazardous potential in terms of these endpoints.
No DNELs were derived for local effects after short term or after long term dermal exposure since the respective systemic long term DNEL is considered sufficient to ensure the absence of local effects.
No DNELs were derived for systemic effects after short term dermal exposure, since the respective systemic long term DNEL is considered sufficient to ensure the absence of acute toxic effects.
No DNELs were derived for systemic effects after short term or after long term inhalative exposure, since inhalation is not considered a relevant route of exposure due to physical chemical properties of retinyl palmitate (liquid with a lack of relevant vapour pressure) and the absence of relevant exposure scenarios including formation of respirable aerosols.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Since all relevant uses are outside the scope of REACH, i.e. use in food or feeding stuff or medicinal products as referred to in Article 2 (5a,b) of 1907/2006/EEC or use in cosmetic products as defined in Directive 76/768/EEC, no DNELS have been derived for the general population according to "Guidance on information requirements and chemical safety assessment (Chapter R8).
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.