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 pigments of the Naphtol AS group because the substances of this category did not cause relevant toxictiy in any test performed according to the information requirements.

- the substances of this category did not cause lethal effects in rats after administration of a single oral dose of >= 2000 mg/kg, a single dermal dose of 2000 mg/kg or a single inhalation concentration of 1580 mg/cubic metre,

- the substances of this category are not irritating and do not have to be classified as eye or skin irritants,

- the substances of this category caused no relevant systemic toxic effects in several subacute studies in rats (NOAEL 1000 mg/kg/day),

- the substances of this category 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 TG 422; NOAEL 1000 mg/kg bw/day) and a

Reproduction / Developmental Toxicity Screening Test (OECD TG 421; NOAEL 1000 mg/kg bw/day),

- the absence of effects in the above-mentioned toxicity endpoint tests indicates that the substances of this category do not interact with living cells/tissues, and

- it is unlikely that the substances of this category become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. The substances of this category are not likely to be systemically available after oral, dermal or inhalation exposure.

Therefore no DNELs for systemic effects have been derived.

Naphtol AS Pigments do not cause irritation, corrosion or sensitization. They are considered unlikely to become bioavailable in the skin and are considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments of this category 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 pigments of the Naphtol AS group because the substances of this category did not cause relevant toxictiy in any test performed according to the information requirements.

- the substances of this category did not cause lethal effects in rats after administration of a single oral dose of >= 2000 mg/kg, a single dermal dose of 2000 mg/kg or a single inhalation concentration of 1580 mg/cubic metre,

- the substances of this category are not irritating and do not have to be classified as eye or skin irritants,

- the substances of this category caused no relevant systemic toxic effects in several subacute studies in rats (NOAEL 1000 mg/kg/day),

- the substances of this category 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 TG 422; NOAEL 1000 mg/kg bw/day) and a

Reproduction / Developmental Toxicity Screening Test (OECD TG 421; NOAEL 1000 mg/kg bw/day),

- the absence of effects in the above-mentioned toxicity endpoint tests indicates that the substances of this category do not interact with living cells/tissues, and

- it is unlikely that the substances of this category become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. The substances of this category are not likely to be systemically available after oral, dermal or inhalation exposure.

Therefore no DNELs for systemic effects have been derived.

Naphtol AS pigments do not cause irritation, corrosion or sensitization. They are considered unlikely to become bioavailable in the skin and are considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected for the pigments of this category after local exposure, therefore no DNELs for local effects have been derived.