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:
other toxicological threshold
Value:
3 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
3 mg/m³
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 exposure - systemic effects; long-term exposure - systemic effects:

Diarylide Pigment Yellow 12 and its strucutral analogues, the Diarylide Yellow Pigments, are poorly water soluble in generally konwn solvents. Therefore, their bioavailability, and thus the systemic exposure is negligible. Substances that are not bioavailable cannot reach relevant systmic biological targets, e.g. organs, tissues, macromolecules, and thus cannot trigger any systmic (toxic) effect. This assumption is supported by the lack of effects recorded in the available studies (for details please refer to Read Across Jusstification document, IUCLID Chapter 13).

Therefore, no DNEL has to be derived.

Acute / short-term dermal exposure - local effects; long-term dermal exposure - local effects:

Worker DNELs for acute dermal exposure - local effects and long-term dermal exposure- local effects are not derived, because Pigment Yellow 12 and its structural analogues, the Diarylide Yellow Pigments, have not to be classified as irritating to skin or eyes, are considered unlikely to become bioavailable in the skin.

Acute / short-term inhalation exposure - local effects; long-term inhalation exposure - local effects

Pigment Yellow 12 and its strucutral analogues, the Diarylide Yellow Pigments, do not cause irritation, corrosion or sensitization and no studies have been located which investigate the long term-inhalation toxicity of these pigments. 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, 1979): 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 short- and long-term inhalation exposure.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
AF for other interspecies differences:
1
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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

Acute / short-term and long-term dermal exposure - systemic effects; Acute / short-term and long-term inhalation exposure - systemic effects; oral exposure - systemic effects

Diarylide Pigment Yellow 12 and its strucutral analogues, the Diarylide Yellow Pigments, are poorly water soluble in generally konwn solvents. Therefore, their bioavailability, and thus the systemic exposure is negligible. Substances that are not bioavailable cannot reach relevant systmic biological targets, e.g. organs, tissues, macromolecules, and thus cannot trigger any systmic (toxic) effect. This assumption is supported by the lack of effects recorded in the available studies (for details please refer to Read Across Jusstification document, IUCLID Chapter 13).

Therefore, no DNEL has to be derived.

Acute / short term dermal exposure - local effects; Acute / short term inhalation exposure - local effects

General population DNELs for acute exposure - local effects are not derived, because Pigment Yellow 12 and its strucutral analogues, the Diarylide Yellow Pigments, 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 have to be classified regarding respiratory tract irritation. When aerosolized in respirable form, Diarylide Yello Pigments are considered to behave like inert dusts.

Long-term dermal exposure - local effects

A DNEL is not derived because Pigment Yellow 12 and its strucutral analogues, the Diarylide Yellow Pigments, do not cause irritation, corrosion and/or sensitization.

Long-term inhalation exposure - local effects

No DNEL "long-term inhalation exposure - local effects" is derived for Pigment Yellow 12, because the use and exposure pattern "long-term inhalation" exposure is not considered relevant for the general population.