Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Acute / short-term exposure - systemic and local effects

- Dermal:

An acute dermal toxicity study in rats was performed with zirconium oxynitrate hydrate (CAS 14985-18-3), the hydrated form of the reference substance zirconium dinitrate oxide (Bioassay, 2018). In this study no mortalities were observed and the LD50 value was defined to be greater than 2000 mg/kg bw, i.e. not resulting in classification.

Further, no skin irritation was observed in an in vivo skin irritation study in rabbits with zirconium dinitrate oxide (solid form) (Matting, 2015b).

As no adverse effect is expected after acute/short-term dermal exposure to solid zirconium dinitrate oxide, neither for local nor systemic effects, no DNELs need to be derived.

- Inhalation:

No acute toxicity study for the inhalation route is available for zirconium dinitrate oxide, however, this study can be waived based on Column 2 adaptation (REACH Regulation, Annex VIII, section 8.5) (acute toxicity data via two routes available). As there are no acute toxicity data available via inhalation route for zirconium dinitrate oxide, no acute/short-term DNEL could be derived. In addition, the substance is manufactured/used as aqueous solutions and therefore no inhalation exposure is expected.

Long-term exposure - systemic and local effects

- Inhalation:

No long-term inhalation toxicity studies are available for zirconium dinitrate oxide. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (Column 2, Annex VIII, section 8.6.1). Since oral repeated dose toxicity data are available (for the read across substance zirconium acetate), it was not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. In addition, the substance is manufactured/used as aqueous solutions and therefore inhalation exposure is unlikely.

Although experimental data are available from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening performed with the read across substance zirconium acetate (Rossiello, 2013), no long-term DNELs were derived for zirconium dinitrate oxide via route-to-route extrapolation. No systemic hazard was identified up to and including at the highest dose tested in this study (limit dose as per OECD 422). The read across justification is attached to IUCLID Section 13.

National exposure limits for zirconium compounds were defined in various countries in Europe and around the world and are mostly set at 5 mg Zr/m3 for long-term exposure (8-h Time Weighted Average (TWA)) and 10 mg Zr/m3 for short-term exposure. Although no DNEL needs to be derived for zirconium dinitrate oxide, it is advised to carefully check and respect the applicable (national) standards.

- Dermal:

No long-term dermal toxicity studies are available for zirconium dinitrate oxide. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (Column 2, Annex VIII, Section 8.6.1). Since oral repeated dose toxicity data are available (for the read across substance zirconium acetate), it was not necessary to perform a dermal repeated dose toxicity study.

Although experimental data are available from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening performed with the read across substance zirconium acetate, a 'water-soluble' compound with similar behaviour as zirconium dinitrate oxide (Rossiello, 2013), no long-term DNELs were derived for zirconium dinitrate oxide via route-to-route extrapolation. No systemic hazard was identified up to and including at the highest dose tested in this study (limit dose as per OECD 422). The read across justification is attached to IUCLID Section 13.

Hazards for the eyes

Based on the data available data (Váliczkó, 2014), zirconium dinitrate oxide was concluded to be classified as Eye Damage 1. No DNEL can be derived for this specific hazard. This hazard is dealt with in the qualitative assessment in the Chemical Safety Report (attached to IUCLID Section 13).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Zirconium dinitrate oxide is not used by consumers as such and is not present in articles used by consumers. Moreover, it is not likely that zirconium dinitrate oxide can significantly expose man indirectly via the environment as a result of industrial emissions, as the substance would be transformed to non-hazardous zirconium forms in environmentally relevant media under environmentally relevant conditions. Therefore, no hazards are identified and no DNELs are derived for the general population.

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