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 DNELhas not been derived for Pigment Yellow 120 because the substance did not cause relevant toxictiy in any test performed according to the information requirements.

- the substance did not cause lethal effects after administration of a single oral dose of 15000 mg/kg or in a test for acute toxicity after inhalation exposure up to the highest achievable concentration tested in rats,

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

- the substance does not have to be classified as skin sensitizing based on the findings in a test with guinea pigs,

- the substance caused no relevant systemic toxic effects in a subacute oral study in rats (NOAEL >= 1000 mg/kg/day,

- the substance caused no systemic toxic effects, no effects on fertility or development in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422; 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 its extremely 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 DNEL for systemic effects has been derived.

Pigment Yellow 120 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is not classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments of this category after local exposure, therefore no DNEL for local effects has 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

DNEL has not been derived for Pigment Yellow 120 because the substance did not cause relevant toxictiy in any test performed according to the information requirements.

- the substance did not cause lethal effects after administration of a single oral dose of 15000 mg/kg or in a test for acute toxicity after inhalation exposure up to the highest achievable concentration tested in rats,

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

- the substance does not have to be classified as skin sensitizing based on the findings in a test with guinea pigs,

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

- the substance caused no systemic toxic effects, no effects on fertility or development in a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422; 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 its extremely 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 DNEL for systemic effects has been derived.

 

Pigment Yellow 120 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is not classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments of this category after local exposure, therefore no DNEL for local effects has been derived.

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