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EC number: 417-790-1
CAS number: 78418-01-6
In a repeated dose dermal toxicity study
conducted similarly to the OECD Guideline 410 and in compliance with
GLP, groups of five virgin female rats of the Crl:CD (SD) BR (VAF plus)
strain were dosed once daily for 10 days by dermal application with
suspensions of Mexoryl SAB at dose levels of 2 and 5 %, using a dose
volume of 2 mL/kg bw. A similar group of females was dosed with the
vehicle (PEG 300) only, and served as controls. The formulations were
applied directly to the skin of a clipped area of the back (not less
than 10 % of the body area) and, approximately 6 h after application,
the test site was washed using warm water and dried. Examinations during
the study included: mortality, clinical observation, body weight change,
evaluation of cutaneous tolerance and macroscopic necropsy.
No mortality was recorded during the study.
Animals treated at 5 % were observed to be scratching at the application
site from Day 8 of the dosing period onwards. In this group, very slight
erythema was noted in 2-5 animals from Day 6 onwards and well-defined
erythema was noted in one female between Days 8 and 10 of the dosing
period. In addition, between 3 and 4 animals from this group were
observed with very slight oedema from Day 7 of the dosing period. No
treatment-related changes were observed in food consumption and
bodyweight gain. Occasionally, transient weight losses were observed
which, because of the small group sizes, skewed the means. All animals
from the group treated at 5 % were observed with scabbing
(minimal/moderate) at the application site at necropsy. No other
treatment-related findings were observed at necropsy.
Under the test conditions, the No Observed
Effect Levels (NOEL) for local and systemic effects for Mexoryl SAB to
female rats were considered to be 2 and > 5 %, respectively.
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