Registration Dossier
Registration Dossier
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EC number: 211-525-1 | CAS number: 658-79-7
Endpoint summary
Administrative data
Description of key information
- skin irritation: study conducted according to OECD guideline 404 (1981), GLP, N-glycyl-L-tyrosine dihydrate was applied to the skin under occlusive conditions of three (White Russian) rabbits for 4h, the test item is not irritating to the skin.
- eye irritation: study conducted according to OECD guideline 405 (1981), GLP, N-glycyl-L-tyrosine dihydrate was instilled into the conjunctival sac of three (White Russian) rabbits and the animals were observed for 72h after administration, slight effects were observed which were fully reversible within 72h after administration.
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)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a study according to OECD guideline 404 and GLP compliant, 0.5 g N-glycyl-L-tyrosine dihydrate was applied to the intact dorsal skin of rabbits (White Russian Strain) for four hours under occlusive conditions. After the exposure time the test substance was gently washed off the skin as far as possible. A very slight erythema was reported for one animal one hour after exposure which was fully reversible within the first 24 hours after exposure. Thus, N-glycyl-L-tyrosine dihydrate is considered to be non-irritating.
In a GLP compliant study according to OECD guideline 405, the test substance was instilled into the conjunctival sac of the left eye in three rabbits. Both lids were briefly closed by gentle finger pressure. The other eye of each animal was not treated and acted as control. Application of 40.67 - 43.40 mg resulted in a slight, transient circumcorneal and conjuctival hyperemia. These effects were fully reversible within 48 hours. Thus, the GHS criteria for classification and labeling are not met.
Justification for classification or non-classification
Based on the available, relevant and reliable data N-glycyl-L-tyrosine dihydrate is not classified according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labeling of Chemicals (GHS) with respect to skin and eye irritation/corrosion.
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