Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(phenyl and o-tolyl) derivs.

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

10 mg/m³

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

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

The substance is treated as an inert pigment as all existing data on the category shows absence of effects and insolubility.

Worker DNELs for acute exposure - systemic effects are not derived, because no relevant acute toxicity was observed (LD50 oral >2000 mg/kg bw; LD50 dermal >1710 mg/kg bw; LC50 inhalation > 4.25 mg/L) and no hazards leading to classification and labeling were identified. It is considered unlikely that the Diarylide Yellow Pigments of this category become systemically bioavailable after dermal or inhalation exposure.

Worker DNELs for acute exposure - local effects are not derived, because Diarylide Yellow Pigments of this category have not to be classified as irritating to skin or eyes, are considered unlikely to become bioavailable in the skin and are considered not to be classified regarding respiratory tract irritation.

No data on toxicity of diarylide yellow pigments of this category after long-term dermal exposure are available.The substances of this category are not likely to be systemically available after dermal exposure. In addition, no adverse effects have been upon long-term oral exposure.

In a chronic toxicity study with Pigment Yellow 12 a NOAEL of 555 mg/kg bw/d (male rats) has been derived (Laboratorium für Pharmakologie und Toxikologie, 1977a; Leuschner, 1978).

Therefore, no hazard is identified for the dermal route and no DNEL is derived.

There are no studies with long term inhalation exposure to Diarylide Yellow Pigments of this category available. Two subacute inhalation studies with Pigment Yellow 13 in rats (CIBA, 1979e, f) reveal that the test item does not exert systemic effects but induces local effects due to the deposition of the test material in the respiratory tract.The substances of this category are not likely to be systemically available after inhalation. Therefore no DNEL for long-term inhalation exposure, systemic effects, is derived.

Long-term dermal exposure - local effects: A DNEL is not derived because Diarylide Yellow Pigments do not cause irritation, corrosion and/or sensitization and no data for setting a worker DNEL "long-term dermal exposure -local effects" are available.

Diarylide Yellow Pigments do not cause irritation, corrosion or sensitization and no studies have been located which investigate the long term inhalation toxicity of Diarylide Yellow Pigments of this category. But two studies investigating subacute inhalative toxicity of Pigment Yellow 13 in rats are available, which reveal that the test item does not exert systemic effects but induces local effects due to the deposition of the test material in the respiratory tract (CIBA, 1979e, f): In a 21-day inhalation study (6 h/d, 5 d/w) with Pigment Yellow 13 in rats only minimal deposition of the test material in the respiratory tract without inflammatory response are observed at the lowest test concentration (52 mg/m³). These effects are considered not to be adverse, i. e. 52 mg/m³is a NOAEC. At higher test concentrations substance deposition along with inflammatory responses up to pneumoconiosis are observed. These effects are typical for inert dusts. General dust limits of 10 mg/m³ for the inhalable airborne fraction and 3 mg/m³ for the respirable airborne fraction are used in setting occupational exposure limits in many countries. For this reason, the DNEL is set to the general dust limit which is considered protective of local effects from long-term inhalation exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

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

The general population is not exposed to the substance in an inhalable form. It is always embedded in a coating. It is non volatile and cannot be inhaled in form of vapour.