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

SKIN IRRITATION:

Potassium chloride:

For skin irritation propertis of potassium chloride an experiment was carried out according to OECD 439 and EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany).

Undissolved potassium chloride (KCl) was applied topically to the RHS model, i.e. 30 mg per insert (plus 30µl 0.9% NaCl to moisten and ensure good contact with the skin; three replicates). After an exposure a cell viability of 84.24% was measured. Thus, the results show that potassium chloride (KCl) does not have to be classified regarding skin irritation. This result is confirmed by a study conducted in rabbits by Marhold in 1972. Here also no signs of skin irritating potential were noted.

Glycyl-L-glutamine:

For Glycyl-L-glutamine an in vivo study in rabbits according to the OECD guideline 404 was conducted. At none of the foreseen observation time points after treatment erythema or edema could be ovserved. Therefore also Glycyl-L-glutamine is considered to be not irritating to the skin.

Reaction mass of Glycyl-L-glutamine and potassium chloride:

Based on the data available for both individual main components and in the absence of synergistic or antogonistic effects, the reaction mass of Glycyl-L-glutamine and potassium chloride is considered to be not irritating to the skin.

EYE IRRITATION:

Potassium chloride:

There is an early publication available in which an experiment on rabbits is reported that examined the potential eye irritating property of potassium chloride.

500 mg potassium chloride was instilled into the eye for 24 hours which caused irritating effects of grade 3 / 10. No further detail is available from that study. In a respective study on skin irritation published in parallel by the same research group the result was recorded to be "0", indicative of no relevant skin irritation potential. To evaluate the significance of the result of the eye irritation study and the relevance of the observation for classification a plausibility check was performed by collecting some examples with the same "Marhold evaluation: eye grade 3/10 and skin : 0". These substances are NaNO2, Cas-Nr 7632-00-0; NH4Cl CAS-Nr 12125-02-9: AlF3 CAS-Nr 7784-18-1; CCl4 CAS-Nr 56-23-5: Isophthalic acid CAS-Nr. 121-91-5; Maleic acid CAS-Nr 110-16-7 and CAS-Nr 67-68-5. Only two of them are classified and labelled according to the respective guideline but all of them were reported in reliable reviews to cause irritation effects in the eyes of rabbits of different magnitude

Overall, based on the available data there is some evidence of an eye irritation potential of potassium chloride, but it is unclear whether the classification criteria are fulfilled.

In a recent in vitro study for evaluation of ocular irritant properties by using an artificial human 3D-Cornea model it is shown that potassium chloride (KCL) can be predicted as non-irritant under the condition of this test method.

Thus, overall, potassium chloride is considered as non-irritating to the eye.

Glycyl-L-glutamine:

For Glycyl-L-glutamine a GLP-compliant study according to the OECD guideline 404 was conducted in rabbits. Based on this Glycyl-L-glutamine does not have eye irritating potential.

Reaction mass of Glycyl-L-glutamine and potassium chloride:

Based on the data available for both individual main components and in the absence of synergistic or antogonistic effects, the reaction mass of Glycyl-L-glutamine and potassium chloride is considered to be not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
For both main components of the reation mass of Glycyl-L-glutamine and potassium chloride studies on their irritating portential for skin were conducted. In none of the studies signs for irritating potential for the skin were reported. As no study for the reaction mass of Glycyl-L-glutamine and potassium chloride is available, studies conducted with the two main components L-glycyl-L-glutamine and potassium chloride (such as this) were used for read-across in order to avoid unnecessary repitition of testing. As no synergistic or antagonistic effects from either of the main components are expected, the information derived from both main components is considered to be reliable for classification of the reation mass of Glycyl-L-glutamine and potassium chloride. Hence the reaction mass of Glycyl-L-glutamine and potassium chloride is not classified regarding its irritating portential for the skin.

Justification for classification or non-classification