Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Acute / short-term exposure - systemic and local effects

- Dermal:

An acute dermal toxicity study in rats was performed with the read across substance zirconium acetate (Longobardi, 2013). In this study no mortalities were observed and the LD50 value was defined to be greater than 2000 mg/kg bw, leading to no classification.

Taking into account the concept that the more water soluble is the substance the higher is its potential for systemic bioavailability, it can be assumed that zirconium basic sulfate (an insoluble zirconium compound) will be of an even lower concern than zirconium acetate (a 'water soluble' zirconium compound) for acute dermal toxicity. As no adverse effect is expected after acute/short-term dermal exposure, neither for local or systemic effects, no DNELs need to be derived.

- Inhalation:

No acute toxicity study for the inhalation route is available for zirconium basic sulfate, 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 basic sulfate, no acute/short-term DNEL could be derived. In addition, the substance is marketed as a paste 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 basic sulfate and this test is also waived based on the following information: reliable information is available for the oral route of exposure with the read across substance zirconium acetate (a 'water soluble' zirconium compound) as source of zirconium (Rossiello, 2013) and, 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). Therefore, it was not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. In addition, the substance is marketed as a paste and therefore inhalation exposure is unlikely. Although experimental data from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening performed with the read across substance zirconium acetate are available (Rossiello, 2013), no systemic hazard was identified up to the highest dose tested (limit dose as per OECD 422) that could be used to derive a DNEL using 'route-to-route extrapolation'. Based on all abovementioned considerations and the fact that there is sufficient evidence available indicating that zirconium is barely absorbed after inhalation exposure to zirconium basic sulfate (see section 7.1), no DNEL long-term (systemic or local effects) needs to be derived.

National exposure limits for zirconium compounds were defined in Europe by 15 national authorities and set at 5 mg/m3 (expressed as Zr). In the USA, NIOSH, ACGIH, and OSHA have evaluated toxicity and defined long-term and short-term exposure limits for zirconium dioxide. The 8-h Time Weighted Average (TWA) was set at 5 mg Zr/m3 whereas the Short Term Exposure Limit (STEL) was set at 10 mg Zr/m3. These values were based on the results of Spiegl et al. (1956) with zirconium dioxide as well as on the results of the study from Hodge (1955). The study of Hodge (1955), is a 1-year experiment performed on rats with zirconium oxide dust at a low dose of 3.5 mg/m3. Unfortunately the unpublished study was not accessible.

Although no DNEL needs to be derived for zirconium basic sulfate, it is advised to respect, when relevant, the current generic standards for zirconium compounds as mentioned above.

- Dermal:

No long-term dermal toxicity studies are available for zirconium basic sulfate and this test is also waived based on the following information: reliable information is available for the oral route of exposure and, 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). Therefore, it was not necessary to perform a repeated dose toxicity study via the dermal route of exposure. As there is no adequate data, no DNEL dermal exposure (systemic effects) is derived. Although experimental data from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening performed with the read across substance zirconium acetate are available (Rossiello, 2013), no systemic hazard was identified up to the highest dose tested (limit dose as per OECD 422) that could be used to derive a DNEL using 'route-to-route extrapolation'. Based on all abovementioned considerations and the fact that there is sufficient evidence available indicating that zirconium is barely absorbed after dermal exposure to zirconium basic sulfate (see section 7.1), no DNEL long-term (systemic or local effects) needs to be derived.

Hazards for the eyes

Based on the data available, zirconium basic sulfate was concluded not to be classified as hazardous to eyes. Therefore no qualitative assessment is required.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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

Acute / short-term exposure - systemic and local effects

- Dermal:

An acute dermal toxicity study in rats was performed with the read across substance zirconium acetate (Longobardi, 2013). In this study no mortalities were observed and the LD50 value was defined to be greater than 2000 mg/kg bw, leading to no classification.

Taking into account the concept that the more water soluble is the substance the higher is its potential for systemic bioavailability, it can be assumed that zirconium basic sulfate (an insoluble zirconium compound) will be of an even lower concern than zirconium acetate (a 'water soluble' zirconium compound) for acute dermal toxicity.

As no adverse effect is expected after acute/short-term dermal exposure, neither for local or for systemic effects, no DNELs need to be derived.

- Inhalation:

No acute toxicity study for the inhalation route is available for zirconium basic sulfate, 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 basic sulfate, no acute/short-term DNEL could be derived. In addition, the substance is marketed as a paste and therefore no inhalation exposure is expected.

- Oral:

One reliable acute toxicity study in rats is available with zirconium basic sulfate (Cuthbert and Jackson, 1992a). In this study there were no deaths following a single oral dose of zirconium basic sulfate (5000 mg/kg) administered to a group of 5 male and 5 female rats. The Median Oral Lethal Dose (LD50) in rats was greater than 5000 mg/kg (test substance). Based on available experimental data, there are no acute toxic effects leading to classification and labeling, hence no acute/short-term DNEL needs to be derived.

Long-term exposure - systemic and local effects

- Inhalation:

Based on the available data and the same argumentation as for workers, no long-term DNEL needs to be derived for the general population. In addition, no officially set values are available for the general population.

- Dermal route:

Based on the same argumentation as for workers, no long-term DNEL needs to be derived for the general population.

- Oral route:

Information after repeated oral exposure to the read across substance zirconium acetate (a 'water soluble' zirconium compound) is available. The assessment of these data does not indicate any adverse effects up to the highest (limit) test dose. Therefore, it is not considered necessary to derive a long-term DNEL.

Further argumentation on read across and the overall extremely low potential of zirconium compounds for causing toxicity is given in the read across justification attached to Section 13 of IUCLID.

Hazards for the eyes

Based on the data available, zirconium basic sulfate was concluded not to be classified as hazardous to eyes.