Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-743-0 | CAS number: 7718-54-9
Endpoint summary
Administrative data
Description of key information
Values used for CSA:
NOAEL (oral, systemic, animal): 100 mg NiCl2.6H2O/kg bw(or 22 mg Ni/kg bw/day) (FDRL, 1983)
LOAEL (oral, systemic, human data; read-across): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999)
NOAEC (inhalation, systemic, animal): 0.054 mg NiCl2.6H2O/L air (13.33 mg Ni/m3) (PSL, 2014/2015) - mortality
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
Additional information
An oral LD50 value of 175 mg for NiCl2 hexahydrate/kg (43 mg Ni/kg) was determined in female rats based on the FDRL (1983) study which served as the basis for classifying Ni chloride as Toxic (Acute Tox. 3; H301). However, a newly conducted GLP OECD guideline compliant study reported an LD50=500 mg/kg for Ni chloride hexahydrate in female rats, suggesting the classification could be downgraded to Acute Tox. 4; H302 according to the 1st ATP to the CLP Regulation, and since a study already exists that results in a more stringent classification, no change to the existing classification is proposed within this registration file. While no change to the existing classification is proposed within this registration file, a complete summary of the study including results and discussion are provided in Section 7.2.1 of IUCLID.
Ni chloride is currently classified as Acute Tox. 3: H331 via the inhalation route according to the 1st ATP to the CLP Regulation. This is further supported by the outcome of the in vivo acute inhalation toxicity studies completed by PSL (2014, 2015), reporting an LC50 of 0.5934 mg/L air for male rats and 0.7464 mg/L for female rats. Therefore, no change to the existing classification is proposed within this registration file. A complete summary of the study including results and discussion are provided in Section 7.2.2 of IUCLID.
There are no available data on which to evaluate acute dermal toxicity. However, acute toxicity is expected to be low in view of the poor absorption by this route. As oral and inhalation routes of exposure are more relevant and data for these have been provided. Testing for acute dermal toxicity is therefore waived based on this information.
The following information is taken into account for any hazard / risk assessment:
ORAL: FDRL (1983) study and recent EPSL (2010) studies on Ni chloride hexahydrate result in a NOAEL = 100 mg NiCl2.6H2O/kg bw.
INHALATION: PSL (2014, 2015) studies of toxicity via inhalation were conducted, which supports the CLP classification, reporting an LC50 of 0.5934 mg/L air for male rats and 0.7464 mg/L for female rats.
DERMAL: No risk characterisation will be conducted for acute dermal toxicity. Acute systemic effects are not relevant due to the very low dermal absorption of nickel. Acute local effects are covered by the long term DNEL based on prevention of dermal sensitization.
Justification for classification or non-classification
Acute oral toxicity. Ni chloride is currently classified for acute oral toxicity as Acute Tox. 3; H301 according to the 1st ATP to the CLP Regulation. A newly conducted GLP OECD guideline compliant study reported an LD50=500 mg/kg for Ni chloride hexahydrate, suggesting the classification could be downgraded to Acute Tox. 4; H302. An Acute Tox 4 classification for nickel chloride would be consistent with the acute oral toxicity classification for all other water soluble nickel compounds. However, a study already exists that results in a more stringent classification and supports the current harmonized classification under the 1st ATP to the CLP.
Acute inhalation toxicity. Ni chloride is currently classified as Acute Tox. 3: H331 according to the 1st ATP to the CLP Regulation. This is further supported by the outcome of the in vivo acute inhalation toxicity studies completed by PSL in 2014 and 2015, reporting an LC50 of 0.5934 mg/L air for male rats and 0.7464 mg/L for female rats. Therefore, no change to the existing classification is proposed within this registration file. A complete summary of the study including results and discussion are provided in Section 7.2.2 of IUCLID.
Ni chloride is not classified for acute dermal toxicity according to the 1st ATP to the CLP Regulation.
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.
