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EC number: 227-873-2
CAS number: 6018-92-4
NOEC (90 d) = 630 mg Trinickel Dicitrate/kg diet
Six sub-chronic and chronic feeding studies in which the
diet was spiked with a Ni salt were identified in the EU-RAR (2008,
seeTable 3.2.4-2 in the attached document of the key endpoint study
record of chapter 6.3.5). The most sensitive lowest observed effect
concentration (LOEC) from these six studies, focusing on endpoints
related to survival, growth, and reproduction, was 300 mg/kg (as added
Ni) based on a 21-day study with White Plymouth Rock day-old male
chicks. This LOEC is based on a 14% reduction in body weight relative to
the control chicks. A NOEC of 150 mg/kg was estimated by Waegeneers and
Smolders (2003) by dividing the LOEC by 2 as per TGD guidance.
In a further study Cain and Pafford (1981) observed
tremors in all ducklings fed a dietary Ni concentration of 800 mg/kg or
greater. Although all but two ducklings in the 800 mg/kg dietary
treatment survived throughout the 90-day exposure period, all ducklings
continued to tremor throughout the experimental period of 90 days. At a
dietary Ni concentration of 200 mg/kg, all ducklings survived and none
developed tremors. So the study of Cain and Pafford (1981) resulted in a
NOEC of 200 mg Ni/kg. More confidence is placed in the NOEC of Cain and
Pafford (1981) than that of Ling and Leach (1979) because the former was
a measured NOEC from a longer study. Nevertheless, both the mallard and
chicken NOECs of 200 and 150 mg Ni/kg (according to 630 and 472 mg Trinickel
Dicitrate/kg), respectively, are used to derive the PNECs in the first
tier of the risk characterization given in the EU-RAR.
Further tiered approach was developed and applied for the
terrestrial food chain. The default approach suggested by the European
Union’s Technical Guidance Document was always used as the first tier.
If potential risk was concluded from this tier, then in subsequent
assessment tiers, refinements on absorption of dietary nickel and the
dietary composition of the predators were considered.
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