Registration Dossier

Administrative data

Endpoint:
long-term toxicity to birds
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex X, section 9.6.1, column 2 of REACH Regulation, the long-term toxicity in birds was regarded as unnecessary due to the comprehensive amount of higher tier repeated dose toxicity studies that are available for rats. A chronic oral toxicity study equivalent to OECD TG 452 did not show any adverse effects in rats when treated with 5 % of the test substance in diet. Survival was comparable to control groups. Body weight was slightly but not significantly retarded in male animals at that dose. Female animals showed normal body weights at the end of the treatment period. Organ weights, urinalysis and gross pathology did not reveal any adverse effects in male and female rats up to the 5 % in diet. Histopathological findings were also comparable to the control group.
Furthermore, no teratogenic or maternal effects were observed when tested orally in hamsters, mice and rats. All three studies were conducted comparable to OECD TG 414. No embryotoxic or teratogenic and maternal effects were observed up to the highest tested concentration of 1600 mg/kg bw/d.
It was therefore decided to waive the long-term toxicity for birds as no scientific added-value is to be expected.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion