Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 Solvent Blue 104 because the substance did not cause relevant toxicity in any test performed according to the information requirements.

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

- the substance is not irritating and does not have to be classified as eye or skin irritant,

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

- the substance caused no relevant systemic toxic effects in a subacute oral toxicity study in rats (NOAEL 1000 mg/kg bw/day)

- 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),

- the absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that the substance does not interact with living cells/tissues, and

- it is unlikely that the substance becomes systemically bioavailable due to their low solubility in water and low solubility in n-octanol. The substance is not likely to be systemically available after oral, dermal or inhalation exposure.

Therefore no DNELs for systemic effects have been derived.

Solvent Blue 104 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

General population DNELs have not been derived for Solvent Blue 104 because the substance did not cause relevant toxicity in any test performed according to the information requirements.

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

- the substance is not irritating and does not have to be classified as eye or skin irritant,

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

- the substance caused no relevant systemic toxic effects in a subacute oral toxicity study in rats (NOAEL 1000 mg/kg bw/day)

- 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),

- the absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that the substance does not interact with living cells/tissues, and

- it is unlikely that the substance becomes systemically bioavailable due to their low solubility in water and low solubility in n-octanol. The substance is not likely to be systemically available after oral, dermal or inhalation exposure.

Therefore no DNELs for systemic effects have been derived.

Solvent Blue 104 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.