Registration Dossier

Administrative data

Description of key information

Biofert Plusz is not irritant to the skin of rabbits. Only very slight erythema (barely perceptible) was detected in rabbits 24 h (in 2/3 rabbits) and 48 h (1/3) after patch removal and no effects after 72 h.
Biofert Plusz is not irritant to the eyes of rabbits. Only conjunctival redness score 1 (some blood vessels definitely hyperemic) was detected in rabbits 24 h and 48 h (in 2/3 rabbits) after instillation which was completely reversuble within 72 h.

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 was tested in a GLP study according to OECD guideline 404 (adopted 2002). Two female and one male New Zealand White rabbits received dermal semi-occlusive application of 0.5 mL of the undiluted test item to the shaved intact left flank. The duration of treatment was four hours and scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. After 1 h erythema score 2 was observed in alll three animals, however, after 24 h score 1 was found in 2 animals and after 48 h score 1 only in one rabbit. No edema was detected at any observation period. All effects were completely reversible, no erythema was noted 72 h after patch removal. In conclusion, Biofert Plusz is not irritant to the skin according to GHS criteria in EC Regulation No. 1272/2008.

Eye irritation was tested in a GLP study according to OECD guideline 405 (adopted 2002). One male and two female New Zealand White rabbits received each instillations of 0.1 mL of the undiluted test item into the left conjunctival sac; no washing of the eyes was performed. Eyes were scored 1, 24, 48 and 72 hours after instillation. No abnormal findings in the cornea or iris of any animal at any of the scoring intervals was detected; a slight reddening of the conjunctivae (score 1) was noted in all three animals 1 h after treatment and which persisted in two animals for up to 48 h; a slight swelling (chemosis) of the conjunctivae in one female was found only 1 hour after instillation. Slight reddening of the sclerae was present in all animals 1 hour after treatment but not at later time points. All effects were reversible within 72 h after instillation. No staining was produced by the test item. In conclusion, Biofert Plusz is not irritant to the eye according to GHS criteria in EC Regulation No. 1272/2008.

Justification for classification or non-classification