Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
DNEL (Derived No Effect Level)
Value:
3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
DNEL (Derived No Effect Level)
Value:
45 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
12
Modified dose descriptor starting point:
NOAEL
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 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. Finally, there is no established accepted methodology for the derivation of acute toxicity DNELs existing.


Acute / short term inhalation exposure - local effects


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. Finally, there is no established accepted methodology for the derivation of acute toxicity DNELs existing. Apart from that, relevant occupational exposure limits for inert dusts should be applied (see below for justification).


Long-term inhalation exposure - systemic effects


There are no studies with long term inhalation exposure to Pigment Yellow 13 available. Two subacute inhalation studies with Pigment Yellow 13 in rats (CIBA, 1979e, f) reveal that the test item does not exert systemic effects.The substance is not likely to be systemically available after inhalation. Therefore, no DNEL long-term inhalation exposure systemic effects is not derived, but set as the general limit for dust at the workplace (3 mg/m³).


Long-term dermal exposure - local effects


A DNEL is not derived because Pigment Yellow 13 does 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


Pigment Yellow 13 does not cause irritation, corrosion or sensitization and no studies have been located, which investigate the long term inhalation toxicity of Pigment Yellow 13. 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/mis 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:
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
Most sensitive endpoint:
repeated dose toxicity
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
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

General population DNELs for systemic as well as local 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 Piment Yellow 13 becomes systemically bioavailable after oral, dermal or inhalation exposure. Finally, there is no exposure of the general population to the pure pigment powder


Pigment Yellow 13 is not classified as irritating to skin or eyes, is considered unlikely to become bioavailable in the skin and is  classified regarding respiratory tract irritation. Finally, there is no established accepted methodology for the derivation of acute toxicity DNELs existing. 


Long-term dermal exposure - systemic effects


No data on toxicity of Pigment Yellow 13 after long-term dermal exposure are available.The substanceis not likely to be systemically available after dermal exposure. There is no exposure of the general population to the pure pigment powder