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Administrative data

Description of key information

In two acute oral toxicity studies, LD50 values of greater than 2000 mg/kg bw/d and above 10000 mg/kg bw/d were determined for male and female Sprague Dawley rats. No mortality was observed in any of the two tests. (MHLW, 2002; BASF, 1978)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
Guideline compliant study.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Data for C.I. Pigment Green 50 (spinel pigment based on cobalt (II)/nickel (III)/zinc titanate) are not available. Thus read across was performed with C.I. Pigment Yellow 53 (nickel antimony titanium yellow). The two Nickel-containing pigments belong to a family of spinel and rutile pigments that have been tested for ion leaching (please refer to IUCLID section 7.9.3) and have been exempted from classification based on non-availability of ion toxicophores. The heavy metal oxides (used for Pigment manufacturing) are absorbed by the spinel resp. rutile lattice and thus lose their chemical, physical, and physiological properties. Both pigments show a very low water solubility (< 0.05 mg/L) being practically physiologically inert. Thus, it can be concluded, that the chemical behaviour towards the different toxicological endpoints is similar for both pigments. Therefore all toxicological endpoints were addressed with C.I. Pigment Yellow 53.

Acute oral toxicity

One OECD guideline 401 compliant study under GLP (MHLW 2002) reported no mortalities, clinical signs or necropsy findings in male and female CD rats after oral treatment with 2000 mg/kg bw per oral gavage. After an observation period of 14 d, the LD50 is > 2000 mg/kg in rats.

The second test was performed according to a standardized internal method, which is in principle comparable to the OECD TG 401 but did not follow GLP requirements (BASF, 1978). Since there were no mortalities, clinical signs or necropsy findings observed in male and female Sprague-Dawley rats dosed with 10000 mg/kg bw after a 14 d observation period, the acute oral LD50 is > 10000 mg/kg bw and the LD0 is >= 10000 mg/kg in rats.

 

Acute dermal and inhalation toxicity

No data were available for acute dermal or inhalative toxicity. Results from repeated dose studies with read across substance C.I. Pigment Yellow 53 (oral 90 d rat, inhalation 5 d rat) indicate no bioavailability for pigments. Additionally, no leaching of metal ions was detected in a leaching study (see chapter 7.9.3) with C.I. Pigment Green 50. Therefore, the dermal exposure pathway is assessed as not relevant. For the inhalative exposure pathway, there are no indications for mechanical effects other than known from inert dusts, which were not relevant for acute toxicity.

 


Justification for selection of acute toxicity – oral endpoint
Guideline compliant study.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for acute toxicity under Directive 67/548/EEC.

                               

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No. 1272/2008.