Registration Dossier

Administrative data

Workers - Hazard via inhalation 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
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:
no hazard identified

Additional information - workers

Worker DNELs have not been derived for the submission substance because the test item did not cause relevant toxicity in any test performed according to the information requirements.

- the substance did not cause lethal effects or signs of systemic toxicity after administration of a single oral or dermal dose of 2000 mg/kg in tests for acute toxicity in rats,

- the substances is not irritating and do not have to be classified as eye or skin irritant, based on findings from in vitro and in vivo tests for skin and eye irritation/corrosion,

- the substance does not have to be classified as skin sensitizing based on the findings in a Local Lymh Node Assays in mice,

- the substance caused no relevant systemic toxic effects in a subacute oral study in rats (NOAEL: 1000 mg/kg/day, no adverse effects up to the highest dose tested),

- the substance did not induce any mutations in a battery of in vitro genetic toxicity tests,

- the substance caused no systemic toxic effects, and no effects on fertility or development in a Reproduction / Developmental Toxicity Screening Test (OECD Guideline 421; NOAEL: 1000 mg/kg bw/day, no adverse effects up to the highest dose tested),

- the absence of effects in the above-mentioned toxicity endpoint tests indicates that the substance does not interact with living cells or tissues after oral and dermal exposure for up to 39 days, and

- it is unlikely that relevant amounts of the substances become systemically bioavailable due to its low solubility in water and its insolubility in n-octanol. The substance is not likely to be systemically available in relevant amounts after oral, dermal or inhalation exposure..

Therefore no DNELs for systemic effects have been derived.

The substance does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected after local exposure, therefore no DNELs for local effects have been derived.

Apart from that, relevant occupational exposure limits for inert dusts should be applied.

General Population - Hazard via inhalation 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
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

DNELs for the general population have not been derived for the submission substance because the test item did not cause relevant toxicity in any test performed according to the information requirements.

-the substance did not cause lethal effects or signs of systemic toxicity after administration of a single oral or dermal dose of 2000 mg/kg in tests for acute toxicity in rats,

- the substances is not irritating and do not have to be classified as eye or skin irritant,based on findings from in vitro and in vivo tests for skin and eye irritation/corrosion,

-the substance does not have to be classified as skin sensitizing based on the findings in a Local Lymh Node Assays in mice,

-the substance caused no relevant systemic toxic effects in a subacute oral study in rats (NOAEL: 1000 mg/kg/day, no adverse effects up to the highest dose tested),

- the substance did not induce any mutations in a battery of in vitro genetic toxicity tests,

-the substance caused no systemic toxic effects, and no effects on fertility or development in a Reproduction / Developmental Toxicity Screening Test (OECD Guideline 421; NOAEL: 1000 mg/kg bw/day, no adverse effects up to the highest dose tested),

- the absence of effects in the above-mentioned toxicity endpoint tests indicates that the substance does not interact with living cells or tissues after oral and dermal exposure for up to 39 days, and

- it is unlikely that relevant amounts of the substances become systemically bioavailable due to its low solubility in water and its insolubility in n-octanol. The substance is not likely to be systemically available in relevant amounts after oral, dermal or inhalation exposure.

Therefore no DNELs for systemic effects have been derived.

The substance does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected after local exposure, therefore no DNELs for local effects have been derived.