Registration Dossier

Administrative data

Description of key information

Skin and eye irritation studies on KGA, the major component with ascorbic acid of KGA Greens, were conducted under GLP conditions using rabbits and current OECD guidelines.  No signs of skin irritation were observed, but KGA was found to be irritating to the eyes.

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:
adverse effect observed (irritating)

Respiratory irritation

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

Additional information

Skin and eye irritation studies on KGA, the major component with ascorbic acid of KGA Greens, were conducted under GLP conditions using rabbits and current OECD guidelines. No signs of skin irritation were observed, but KGA was found to be irritating to the eyes.

For the skin irritation study, KGA was placed on the skin of 3 female rabbits for 4 hrs, and covered with a semi-occlusive patch. After 4 hrs, the test substance was removed with warm water. The animals were scored for signs of edema and erythema according to the Draize scale at 1, 24, 48, and 72 hrs and carried out through day 8 to ensure reversibility. A very slight sign of erythema was seen at hour 1, while signs of edema were seen at the 2 hr observation. The primary irritation index was 1.5, based on the cumulative mean scores of edema and erythema and all symptoms were fully reversible. The test substance is therefore not classified as a skin irritant according to EU GHS guidelines.

For the eye irritation study, 0.1 g of KGA was placed in one eye of one female rabbit. The untreated eye served as control. The animals were examined for signs of irritation at 1, 24, 48, and 72 hours, as well as daily up until day 22 after application. The mean score for the cornea was 3.75, while the mean score for the iris was not determined as it was not able to be seen until day 5 of the study. The mean conjunctivae scores were 1.25 and 2.25 for A and B, respecitively. The test substance is classified as an eye irritant under EU GHS guidelines.


Effects on eye irritation: irritating

Justification for classification or non-classification

Significant effects warranting classification were not observed in the skin irritation studies conducted on KGA and therefore KGA Greens is not classified as a skin irritant. Significant effects were, however, observed in the eye irritation study conducted on KGA, and since it is expected that the other major component of KGA Greens (ascorbic acid) would act similarly, KGA Greens is classified as an eye irritant under the EU GHS and DSD guidelines.