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EC number: 204-844-2 | CAS number: 127-47-9
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Additional information
Skin irritation:
In the key study for skin irritation according to GLP and OECD guideline 404, New Zealand White Rabbits were treated dermally (semiocclusive) with retinyl acetate (1.5 mlU/g) (DSM 221040). The mean scores for erythema was 1.4 (24, 48 and 72 hours, 3 animals), and none of the animals showed a mean erythema score >=2. The erythema observed was fully reversible within 14 days and scaling was observed in 1/3 animals. None of the animals showed edema. Considering the given information on test substance concentration, i.e. 1.5 mlU/g, as 1500000 IU/g, a concentration of retinyl acetate in the tested substance is assumed to be 516 mg/g or approx 52%.
In the key study for skin irritation according to the OECD guideline 404 (deviation from current guideline: occlusive application, observation period), retinyl acetate (860 mg/g test substance or 86% in the test substance) induced mean scores for erythema of 2.3 and edema of 1.0 (24, 48 and 72 hours, 6 animals) in Vienna White rabbits (BASF 82/202-205). Erythema were found to be not fully reversible in 5/6 animals until the end of the observation period (8 days), whereas edema fully reversed within 8 days. Scaling was observed in 6/6 animals at the end of the study.
Dermal irritation testing of substances containing retinyl acetate in rabbits under stringent use conditions, that do not represent current standart protocols (occlusive application for 24 hours), provide further evidence for an irritating potential of retinyl acetate.
In a guideline study (OECD guideline 404, GLP), the strucutrally related substance retinyl propionate (purity approx. 90%) induced reversible erythema and edema in New Zealand White Rabbits and individual erythema mean scores (24 -72 hrs) were >=2 (but <2.3 in 2/3 animals; DSM B-154'448). Reversible desquamation or scabbing, epidermal lesions and scaling was observed in 3/3 animals. These findings on retinyl propionate provide further evidence for an irritating potential of retinyl acetate to the skin.
Eye Irritation:
The key study for eye irritation was performed according to GLP and OECD guideline 405, using New Zealand White Rabbits (DSM 221005). Reversible conjunctival redness was noted at the 1 hour observation time point after instillation of the test substance. However, mean scores (24-72 hour time points) for corneal opacity, iris, redness or chemosis of the conjuctivae was 0 in all animals observed. The test substance is not irritating to the eye under the chosen test conditions. Considering the given information on test substance concentration, i.e. 1.5 mlU/g, as 1500000 IU/g, a concentration of retinyl acetate in the tested substance is assumed to be 516 mg/g or approx 52%.
Further eye irritation tests with test substances containing retinyl acetate (approx. 50%) only showed slight conjunctival redness during the observation time (72 hours), but confirm the absence of an irritating potential to the eye, as observed in the key study.
In a guideline study (OECD guideline 405, GLP) using New Zealand White Rabbits and retinol propionate (approx. 90%; DSM B-154´433), slight conjuctival redness was observed in 1/3 animals (reversible after 72 hours). No effects on corneal opacity, iris or chemosis of the conjuctivae were noted. These findings on retinyl propionate provide further evidence for the absence of an eye irritating potential of retinyl acetate.
Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
The present data fulfill the criteria laid down in 67/548/EEC and a classification "irritating to skin" (R38) is warranted.
According to 1272/2008/EEC, a non-classification is warranted.
According to UN-GHS, the test substance needs to be classified "skin irritant" (category 3).
The present data on eye irritation do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC, and a non-classification is warranted.
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.
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