Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-844-2 | CAS number: 127-47-9
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.
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.
