Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

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.

Similar results were observed a supporting study with mean Draize scores of 0.5 for erythema on intact skin. This mild effect was fully reversible within 72 h (Ebbens, 1973).

Additionally a short report is available in which MDA was estimated to be not irritating (Hollingworth, 1954). Undiluted MDA was tested on intact and abraded skin in 1 animal each. Very slight scaliness was described on the intact skin, and slight reversible hyperemia was observed on the abraded 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).

Similar mild eye reactions were observed in a supporting study with 100mg MDA. Following application into the conjunctival sac mild irritation was reversible in 5 of 6 animals, in one animal reversion occurred between day 3 and 7 (Ebbens, 1973).

Additionally a short report is available in which MDA-instillation into the eye of rabbits resulted in a slight transient conjunctivitis (Hollingworth, 1954).

 


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

According to EU- and GHS- legislation no classification for eye irritation is indicated.

Human data on irritating effects to eyes are not available.