Registration Dossier

Administrative data

Description of key information

Two studies for skin irritation according OECD 404 with Bayplast Gelb 5G and Bayplast Gelb 5 GN 01 are available.
An eye irritation study according OECD 405 (LPT 2013) and an in-vitro study on a 3D-cornea model with Bayplast E4GN are available. Additional 2 studies with Bayplast Gelb 5G and Bayplast Gelb 5 GN 01 were conducted.

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 the key study for skin irritation/corrosion the test substance was not irritating (erythema and edema score: 0 of max. 4; 24, 48, and 72 h).

In the key study for eye irritation the exposure of the test substance to the eye caused conjunctival redness (grade 1) in all animals 60 minutes and 24 hours after administration, in animal nos. 1 and 3 until 48 hours after administration. The corneae and irises were not affected by administration of the test item. This finding is supported by an in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model, in which Gelbpigment E4GN is predicted as non-irritant to eyes.

Eye irritation studies with Bayplast Gelb 5G and Bayplast Gelb 5 GN 01 showed some irritation whereas studies with Gelbpigment E4GN showed no eye irritation potential. Since Gelbpigment E4GN is well characterized and a representative and recent compound preparation the data on Gelbpigment E4GN are considered to be more relevant than the data on the earlier compound preparations Bayplast Gelb 5G and Bayplast Gelb 5 GN 01, which might contain additives and/or additional impurities responsible for the observed effects. Since no relevant skin irritation and no acute oral toxicity were observed with Bayplast Gelb 5G and/or Bayplast Gelb 5 GN 01 no additional testing was conducted for these endpoints.

Justification for classification or non-classification

Due to results of the key study for skin irritation (erythema and edema score 0 of 4) and the key study for eye irritation (conjuctivae score 0.55 of 3) a classification for skin irritation and eye irritation is not justified.