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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 PR208 because the substance and its read-across source substance PB25 did not cause relevant toxictiy in any test performed according to the information requirements.

- PR208 did not cause lethal effects after administration of a single oral dose of >= 15000 mg/kg in atest for acute toxicity in rats,

- Read-across source substance 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.
- PR208 is not irritating and does not have to be classified as eye or skin irritants,
- PR208 does not have to be classified as skin sensitizing based on the findings in several Local Lymh Node Assays in mice,
- PR208 caused no relevant systemic toxic effects in a combined repeated dose / reproductive toxicity study in rats (NOAEL >= 1000 mg/kg/day) according to OECD Guideline 422

- The absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that PR208 does not interact with living cells/tissues, and

- It is unlikely that PR208 would become systemically bioavailable due to its extremely low solubility in water and low solubility in n-octanol. PR208 is not likely to be systemically available after oral, dermal or inhalation exposure. Therefore no DNELs for systemic effects have been derived.

PR208 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 PR208 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 PR208 because the substance and its read-across source substance PB25 did not cause relevant toxicity in any test performed according to the information requirements.

- PR208 did not cause lethal effects after administration of a single oral dose of >= 15000 mg/kg in atest for acute toxicity in rats,

- Read-across source substance 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.
- PR208 is not irritating and does not have to be classified as eye or skin irritants,
- PR208 does not have to be classified as skin sensitizing based on the findings in several Local Lymh Node Assays in mice,
- PR208 caused no relevant systemic toxic effects in a combined repeated dose / reproductive toxicity study in rats (NOAEL >= 1000 mg/kg/day) according to OECD Guideline 422

- The absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that PR208 does not interact with living cells/tissues, and

- It is unlikely that PR208 would become systemically bioavailable due to its extremely low solubility in water and low solubility in n-octanol. PR208 is not likely to be systemically available after oral, dermal or inhalation exposure. Therefore no DNELs for systemic effects have been derived.

PR208 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 PR208 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.