Registration Dossier
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EC number: 936-276-2 | CAS number: -
Toxicity to birds
Administrative data
Link to relevant study record(s)
Description of key information
According to transformation/dissolution study (OECD guidance 29) conducted for the target substance, the readily soluble constituent of the target substance is lead. It is also nonessential and the most hazardous constituent in relation to the secondary poisoning. Therefore, the chemical safety assessment focuses on the toxicity of lead to birds and the key value for CSA is selected from lead toxicity studies on birds.
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for birds:
- 100 mg/kg food
Additional information
Because the target substance is an inorganic solid UVCB substance and insoluble to water, the environmental fate and toxicity is related to the soluble (bioavailable) constituents of the substance. According to the T/D study results conducted for the target substance, the readily soluble of this substance is lead. The other bioavailable constituent is zinc. The bioavailable form of these constituents in the substance is sulphate. The read-across justification is presented in CSR annex I.
Lead is considered to be the most critical constituent in relation to the bioaccumulation potential and secondary poisoning for exposure of man via environment. This conclusion is based on the bioaccumulation potential of lead and its nonessential and toxic nature.Zinc is an essential element that is regulated throughout the food chain and does not bioaccumulate/biomagnify. For this reason, the potential for secondary poisoning is not considered relevant for zinc (EU risk assessment, ECB 2008), and testing of long-term toxicity to birds and secondary poisoning of zinc does not need further investigations for CSA.
On the other hand, lead iscarcinogenic, reproduction toxic and causes repeated dose toxicity. It is also the main component and the only readily soluble constituent of the target substance (the T/D study; OECD guidance 29). In soil, lead has a strong binding capacity to organic matter especially to humic surface soils. Therefore, the secondary poisoning and toxicity to birds is focusing on the properties of lead. The exposure assessment and risk characterisation for man via environment focuses on the lead emissions via inhalation and via food consumption.
Toxicity of lead and its compounds
The sub-chronic and chronic studies for 3 different bird species were collected from literature, i.e. for Gallus domesticus, Gallus sp., Colinus virginianus (Bobwhite quail) andCoturnix japonica(Japanese quail). For birds oral toxicity the values varied between 100 and 2000 mg/kg ww. The lowest value of 100 mg/kg (6-wk NOEC, Coturnix coturnix japonica)was used to derive the PNEC, which was observed in several experiments with Japanese quails after 12 weeks.
According to the guidance, the PNEC oral was calculated from the lowest NOEC oral using an assessment factor.An assessment factor of 6 has been selected on the lowest toxicity data. Considering a background concentration of 1.3 mg Pb/kg in the food, the PNEC oral can be calculated as: PNEC oral = (NOEC +Cb) /AF = (100+1.3) /6 = 16.9 mg/kg food (birds). See CSR section 7.6 for further information on PNEC derivation.
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