Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

The two repeated dose toxicity studies for the substance (dog and rat, see Section 7.5.1) provide no information to explain why these strains or species were selected or how they compare to human, and there was no information on internal dose or test substance distribution or elimination. The data are insufficient to characterize the toxicokinetics of the test substance.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
100
Absorption rate - dermal (%):
100
Absorption rate - inhalation (%):
100

Additional information

Concerning bioaccumulation potential, REACH Information Requirements, Chapter R.11 PBT Assessment (ECHA 2008) states that the aquatic BCF of a substance is probably lower than 2000 L/kg if the calculated log Kow is higher than 10. The log Kow for the test substance was estimated to be 12.33 (KOWWIN, EPI Suite, US EPA 2011); therefore, CYASORB®UV-2908 is believed to have low bioaccumulation potential. The two repeated dose toxicity studies for the substance (dog and rat, see Section 7.5.1) provide no information to explain why these strains or species were selected or how they compare to human, and there was no information on internal dose or test substance distribution or elimination. The data are insufficient to characterize the toxicokinetics of the test substance; therefore, conservative default assumptions were used with regard to 100% absorption.