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EC number: 951-773-4
CAS number: -
A GLP Study according to OECD guideline 439 as beeen performed to to determine the skin irritation potential of "By-product from Guanindinoacetic acid manufacturing". As no irritating effects were observed a study to determine the corrosivity of the test item did not have to be conducted.
A GLP Study according to OECD guideline 437 has beeen performed to to determine the eye irritation potential of "By-product from Guanindinoacetic acid manufacturing". No stand-alone prediction can be made regarding the classification of the test substance By-product from Guanidinoacetic acid manufacturing according to the evaluation criteria.
In the present study the skin irritant potential of By-product from Guanidinoacetic acid manufacturingwas analysed. The EpiDerm™-Standard Model (EPI-200™), a reconstituted three-dimensional humanepidermis model, was used as a replacement for the Draize Skin Irritation Test (OECD TG 404, ) todistinguish between UN GHS “Category 2” skin irritating test substances and not categorized testsubstances (“No Category”) which may be considered as non-irritant. Hereby, the test item wasapplied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activitymeasured by formazan production from MTT after a 60 min exposure and 42 h post-incubation periodand compared to those of the concurrent negative controls.To check the non-specific MTT-reducing capability of the test item 25 mg of the test item was mixedper 1 mL MTT medium and incubated for 60 min at 37 1 °C in the incubator. The mixture did not turnblue/purple. Thus, the additional test with freeze-killed tissues and the quantitative corrections werenot necessary.To check the colouring potential of the test item 25 mg of the test item was mixed per 300 μL aquadest. and/or per 300 μL isopropanol each in a transparent recipient and incubated at 37 ± 1°C for60 min. The mixture showed no relevant colouring detected by unaided eye-assessment. Thus, theadditional test with viable tissues and the quantitative corrections were not necessary.The test item showed no non-specific reduction of MTT and no relevant colouring potential aftermixture with aqua dest. and with isopropanol. Therefore, no additional controls for correction ofpossible false-negative results were necessary.The test item showed no irritant effects. The mean relative tissue viability (% negative control) was> 50% (59.2%) after 60 min treatment and 42 h post-incubation.
The eye irritancy potential of By-product from Guanidinoacetic acid manufacturing was investigated in the bovine corneal opacity and permeability assay.
Preparation of the test item: The test item was suspended with physiological saline 0.9% NaCl (see 10.3) to give a 20% concentration.Visual observation after treatment: None of the corneas treated with By-product from Guanidinoacetic acid manufacturing showed any opacity of the tissue.
Mean in vitro irritation score: 4.10Classification:
☐ UN GHS No Category☒ no stand-alone prediction can be made☐ UN GHS Category 1
The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid.The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
No skin irritating effects could be observed in the performed shin irritation study. Therefore "By-product from Guanidinoacetic acid manufacturing" does not have to be classified as irritant or corrosive to skin.
For eye irritation no stand-alone prediction can be made regarding the classification of the test substance By-product from Guanidinoacetic acid manufacturing according to the evaluation criteria.
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.
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