Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
toxicity to birds
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

Executive summary:

According to Column 2 of Section 9.6.1 in the Annex X of REACH "Any need for testing should be carefully considered taking into account the large mammalian dataset that is usually available at this tonnage level."

Melam has a low toxicity to mammals with NOAELs of 1000 mg/kg bw respectively 500 mg/kg bw in the subchronic toxicity and the developmental toxicity tests. Melam is also of low toxicity to aquatic organisms, not leading to a classification. Melam is not bioaccumulative, and is not a PBT or vPvB-substance. No avian specific indications were obtained up to now that an assessment of secondary poisoning for the aquatic and terrestrial food chains for birds could not be performed by using the mammalian PNEC and applying an additional assessment factor of 10 for birds, as suggested in the Integrated Testing Strategy in the Guidance Document R.7c.

According to Column 2 of Section 9.4. in the Annex X of REACH "These studies do not need to be conducted if direct and indirect exposure of the soil compartment is unlikely." A direct exposure of soil is not intended and an indirect exposure to soil is unlikely, as melam is included into a matrix.

It is concluded that toxicity tests with birds can be waived.

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