Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
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:
3 mg/m³
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

Acute / short-term dermal exposure - systemic effects

Acute / short-term inhalation exposure - systemic effects

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 become systemically bioavailable after exposure. Finally, there is no established accepted methodology for the derivation of acute toxicity DNELs existing.

Acute / short term dermal exposure - local effects

Acute / short term inhalation exposure - local effects

Worker DNELs for acute exposure - local effects are not derived, because Diarylide Yellow Pigments are not classified as irritating to skin or eyes, are considered unlikely to become bioavailable in the skin and are considered not classified regarding respiratory tract irritation. Finally, there is no established accepted methodology for the derivation of acute toxicity DNELs . Apart from that, relevant occupational exposure limits for inert dusts should be applied (see below for justification).

Long-term dermal exposure - systemic effects

The substances are not likely to be systemically available after dermal exposure. Based on the very low water and octanol solubility as well as he h igh molecular weight it is assumed that the dermal absorption and the oral absorption are unlikely and that absorption is similar for both routes of exposure and between species.

Long-term inhalation exposure - systemic effects

There are no studies with long term inhalation exposure to Diarylide Yellow Pigments. 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 under the conditions of lung overload. The substances of this category are not likely to be systemically available after inhalation. Therefore no DNEL long-term inhalation exposure for 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.

Long-term inhalation exposure - local effects

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. But two studies investigating subacute inhalative toxicity of the close analogue 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 under the conditions of lung overload (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 was observed at the lowest test concentration (52 mg/m3). These effects are considered not to be adverse, i. e. 52 mg/m3 is a NOAEC. At higher test concentrations substance deposition along with inflammatory responses up to pneumoconiosis are observed (Lung overload). 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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

No exposure of the general population to pigment powder is anticipated as the general population is exposed to pigment only in preparations with pigments bound tightly in a matrix.

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
DNEL related information
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

No exposure of the general population to pigment powder is anticipated as the general population is exposed to pigment only in preparations with pigments bound tightly in a matrix.

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
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
20
Modified dose descriptor starting point:
NOAEL
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

No exposure of the general population to pigment powder is anticipated as the general population is exposed to pigment only in preparations with pigments bound tightly in a matrix.

Categories Display