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EC number: 227-873-2
CAS number: 6018-92-4
There are no reproduction studies for Trinickel
dicitrate. However, extensive data exist for the read-across substance
The data are taken from the EU-RAR for
nickel sulphate, dated 2008.
Two oral multi-generation reproduction
studies and a range-finding one-generation study of nickel sulphate
hexahydrate are available (Ambrose et al. 1976, SLI 2000a, SLI 2000b).
No effects on fertility have been found in these studies following oral
administration; no data are available for inhalation and dermal contact.
The 3-generation study by Ambrose et al. (1976) and the one-generation
range-finding study (SLI 2000a) indicate NOAELs of 1000 ppm and 500 ppm,
respectively. However, the Ambrose et al. study has a limited reporting
of data and the range-finding study uses only a limited number of
animals (8 per group). Therefore, the most reliable NOAEL is from the
recent OECD TG 416 two-generation study (SLI 2000b) where the NOAEL is
the highest dose investigated, i.e. 10 mg nickel sulphate hexahydrate/kg
bw/day. Effects on male sex organs in rats and mice have been reported
in limited studies after oral (Waltschewa et al. 1972, Sobti and Gill
1989), inhalation (Benson et al. 1988) or subcutaneous (Hoey 1966)
administration. These studies indicate a possible LOAEL and LOAEC for
oral and inhalation exposure of 25 mg nickel sulphate/kg bw/day and 1.6
mg Ni/m3, respectively. A repeated dose toxicity study
provides a NOAEL for effects on sperm and oestrus cyclicity of 2.0 mg
nickel sulphate/m3after inhalation exposure (Dunnick et al.
1989). No effects on male sex organs including sperm quality were found
in the recent oral OECD TG 416 two-generation study (SLI 2000b) and the
NOAEL is therefore the highest dose studied, i.e. is 10 mg nickel
sulphate hexahydrate/kg bw/day.
Benson JM, Burt DG, Carpenter RL, Eidson AF,
Hahn FF, Haley PJ, Hanson RL, Hobbs CH, Pickrell JA, Dunnick JK (1988):
Comparative inhalation toxicity of nickel sulphate to F344/N rats and
B6C3F1 mice exposed for 12 days. Fundam Appl Toxicology 10: 164-178.
Hoey MJ (1966): The effects of metallic
salts on the histology of functioning of the rat testis. J Reprod Fertil
SLI (2000a): An oral (gavage) 1-generation
reproduction study of nickel sulfate hexahydrate in rats. Study No.
3472.1 carried out for NiPERA. Springborn Laboratories, Inc.
Spencerville, Ohio, USA.
SLI (2000b): An oral (gavage) two-generation
reproduction toxicity study in Sprague-Dawley rats with nickel sulphate
hexahydrate. Study No. 3472.2 carried out for NiPERA. Springborn
Laboratories, Inc. Spencerville, Ohio, USA.
Sobti RC, Gill RK, (1989): Incidence of
micronuclei and abnormalities in the head of spermatozoa caused by the
salts of a heavy metal nickel. Cytologica 54: 249-254.
LOAEL = 39.58 mg/kg bw/d Trinickel dicitrate
Developmental toxicity / teratogenicity
Based on the available data, Trinickel dicitrate
needs to be classified:
EU: Reproduction category 2, R61
CLP: Category 1B reproductive toxicity
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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