Registration Dossier
Registration Dossier
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EC number: 230-363-2 | CAS number: 7069-42-3
Endpoint summary
Administrative data
Description of key information
A reliable skin and eye irritation GLP guideline (OECD 404, 405) study was performed in the rabbit. In the skin irritation study, a mean score of >=2.0 (but <2.3 in 2/3 animals) for erythema (24, 48 and 72 hours) and desquamation or scabbing, epidermal lesions and scaling was observed in 3/3 animals. For eye irritation, the mean irritation score for conjuctival redness was 0.33 (at both 24 and 48 hr based on one animal only).
Key value for chemical safety assessment
Additional information
The key study for skin irritation was performed according to GLP and OECD guideline 404, using New Zealand White Rabbits and retinyl propionate (purity approx. 90%; DSM B-154'448).
Reversible erythema and edema was observed. Individual erythema mean scores(24 -72 hrs) were >=2 (but <2.3 in 2/3 animals) and reversible desquamation or scabbing, epidermal lesions and scaling was observed in 3/3 animals. Therefore retinyl propionate was identified to be irritating to the skin.
The key study for eye irritation was performed according to GLP and OECD guideline 405, 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 lesion or chemosis of the conjuctivae were noted. The test substance was not an eye irritant under the conditions of the study.Effect level: empty Endpoint conclusion: Adverse effect observed
Effect level: empty Endpoint conclusion: Adverse effect observed
Justification for classification or non-classification
Skin irritation:
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).
Eye irritation:
The present data on eye irritation do not fulfill the criteria laid down in 67/548/EEC and 1272/2008/EEC.
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