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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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 PR185 because the substances and its read-acros source substances PR176 and PB25 did not cause relevant toxictiy in any test performed according to the information requirements.

- PB25 did not cause lethal effects after administration of a single oral or dermal dose of >= 2000 mg/kg in tests for acute toxicity in rats,
- PR185 is not irritating to the skin or the eyes and does not have to be classified as eye or skin irritants,
- PR185 does not have to be classified as skin sensitizing based on the findings in several Local Lymh Node Assays in mice,
- PR176 caused no relevant systemic toxic effects in a subacute oral study in rats (NOAEL >= 1000 mg/kg/day) according to OECD Guideline 407.

- PR176 caused no systemic toxic effects, no effects on fertility or development in a Reproduction / Developmental Toxicity Screening Test (OECD Guideline 421; NOAEL 1000 mg/kg bw/day),

- The absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that PR185 does not interact with living cells/tissues, and

- It is unlikely that PR185 becomes systemically bioavailable due to its extremely low solubility in water and low solubility in n-octanol. PR185 is not likely to be systemically available after oral, dermal or inhalation exposure.

Therefore no DNELs for systemic effects have been derived.

PR185 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected for PR185 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 PR185 because its read-across source substances PR176 and PB25 did not cause relevant toxicity in any test performed according to the information requirements.

- PB25 did not cause lethal effects after administration of a single oral or dermal dose of >= 2000 mg/kg in tests for acute toxicity in rats,
- PR185 is not irritating to the skin or the eyes and does not have to be classified as eye or skin irritants,
- PR185 does not have to be classified as skin sensitizing based on the findings in several Local Lymh Node Assays in mice,
- PR176 caused no relevant systemic toxic effects in a subacute oral study in rats (NOAEL >= 1000 mg/kg/day) according to OECD Guideline 407.

- PR176 caused no systemic toxic effects, no effects on fertility or development in a Reproduction / Developmental Toxicity Screening Test (OECD Guideline 421; NOAEL 1000 mg/kg bw/day),

- The absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that PR185 does not interact with living cells/tissues, and

- It is unlikely that PR185 becomes systemically bioavailable due to its extremely low solubility in water and low solubility in n-octanol. PR185 is not likely to be systemically available after oral, dermal or inhalation exposure.

Therefore no DNELs for systemic effects have been derived.

PR185 does not cause irritation, corrosion or sensitization. It is considered unlikely to become bioavailable in the skin and is considered not to be classified regarding respiratory tract irritation. No substance specific effects are expected for PR185 after local exposure, therefore no DNELs for local effects have been derived.