Registration Dossier
Registration Dossier
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EC number: 500-036-1 | CAS number: 25214-70-4
Endpoint summary
Administrative data
Description of key information
Value used for CSA:
Skin irritation / corrosion: not irritating
Eye irritation: not irritating
Key value for chemical safety assessment
Additional information
Justification on read-across of data for the 4,4´-isomer of MDA for oligomeric MDA in the scope of REACH is documented in IUCLID Toxicological information and described in sections 5.1 and 5.11 of the CSR.
Summarized animal data on irritation/corrosion is dated and no full GLP/OECD guideline study is available. Though, taken together the information seems to be sufficient in order not classify the substance for irritiation.
Skin irritation:
In a skin irritation study (performed according to CFR 16, II, 1500.41) using MDA (0.5 g) with occlusive conditions, no erythema or edema was observed on intact skin (Draize score = 0). Mild erythema was observed on abraded skin (draize score = 0.17) which was fully reversible within 72 h (Allied Chemical Corp, 1978). According to EU and GHS standards, no classification is required for skin irritation/corrosion.
Oligomeric MDA was tested in rabbits in two studies (Hofmann, 1973 and Hine, 1967). Whilst these studies were not performed according to current guidelines, similar results were observed with an maximum average Draize score of 0.67 recorded confirming that both 4,4’ MDA and oMDA are non-irritating to the skin.
In summary, animal data indicate that there is no need for classification of MDA as an irritant to the skin according to EU- and GHS-directives.
Human data on irritating effects to skin are not available.
Eye irritation:
In a eye irritation study (performed according to CFR 16, II, 1500.41) only mild eye reaction was observed in rabbits following instillation of 100mg MDA into the conjunctival sac. The effects were fully reversible within 72h in 5 out of 6 animals (Dunn, 1978).
Oligomeric MDA was tested in rabbit eyes in two studies (Hofmann, 1973 and Hine, 1967). Whilst these studies were not performed according to current guidelines, similar results were observed with a mild or slight redness (Draize score 1) recorded confirming that both 4,4’ MDA and oMDA are non-irritating to the eyes.
Effect level: empty Endpoint conclusion: Adverse
effect observed
Effect level: empty Endpoint conclusion: Adverse effect
observed
Justification for classification or non-classification
Skin:
In summary, animal data indicate that there is no need for classification of MDA as an irritant to the skin according to EU- and GHS-directives.
Human data on irritating effects to skin are not available.
Eyes:
According to EU- and GHS- legislation no classification for eye irritation is indicated.
Human data on irritating effects to eyes are not available.
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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