Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral:
LD50 cut-off = 500 mg/kg bw nickel hydrogencitrate
Dermal:
LD50 > 2000 mg/kg bw nickel hydrogencitrate

Key value for chemical safety assessment

Acute toxicity: via dermal route

Endpoint conclusion
Value:
mg/kg bw

Additional information

Oral

The oral acute toxicity study has been performed according to OECD guideline 423. First, groups of 6 female Sprague Dawley rats received a single oral dose of 2000 mg/kg bw nickel hydrogencitrate. All animals died within 72 hours after dosing. Mortalities were preceded by a decrease in spontaneous activity associated with partial ptosis, piloerection and bradypnea as well as a decrease in muscle tone and righting reflex. Furthermore, increased lachrymation was observed. In a second step, 6 female rats of the same strain were dosed with 300 mg/kg bw nickel hydrogencitrate. No animal died. At this dose level, there were no effects related to treatment. The LD50 cut-off was determined as 500 mg/kg bw nickel hydrogencitrate.

Inhalation

No reliable acute study public available.

 

Dermal

For the dermal route, a study according to OECD guideline 402 has been performed with nickel hydrogencitrate in 5 Sprague Dawley rats of each sex at a single dose of 2000 mg/kg bw. No mortality occured. There were no treatment-related effects. Therefore, the LD50 was determined as higher than 2000 mg/kg bw.

Remark:

Nickel hydrogencitrate and Trinickel dicitrate are comparable: Since citric acid is a multifunctional acid, at different pH values various intermediate ions like citrate, hydrogencitrate and dihydrogencitrate are formed.

Justification for classification or non-classification

Based on the available data, the substance Trinickel dicitrate needs to be cassified:

Oral

EU: R22 Harmful if swallowed.

CLP: Category 4

Inhalation:

There is conclusive data available which is not sufficient for classification.

Dermal

There is conclusive data available which is not sufficient for classification.