Registration Dossier
Registration Dossier
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EC number: 211-367-3 | CAS number: 640-67-5
Toxicological Summary
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.
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.
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