Registration Dossier
Registration Dossier
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EC number: 235-426-8 | CAS number: 12225-08-0
Toxicological Summary
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 PV32 because the substance and its read-across source substances PR208 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 dose of >= 2000 mg/kg and PR208 did not cause lethal effects after administration of a single oral dose of >= 15000 mg/kg in tests for acute toxicity in rats,
- PB25 did not cause lethal effects after administration of a single
dermal dose of >= 2000 mg/kg to rats,
- PV032 is not irritating to the skin or the eyes and does not have to
be classified as eye or skin irritants,
- PV032 does not have to be classified as skin sensitizing based on the
findings in a Local Lymh Node Assays in mice,
- PR208 caused no systemic toxic effects, and no effects on fertility or development in a Combined Repeated Dose / Reproductive Toxicity Screening Test (OECD Guideline 422; NOAEL > 1000 mg/kg bw/day),
- The absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that PV32 does not interact with living cells/tissues, and is not
- It is unlikely that PV32 become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. PV32 is not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
PV032 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 PV032 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 PV32 because its read-across source substances PR208 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 dose of >= 2000 mg/kg and PR208 did not cause lethal effects after administration of a single oral dose of >= 15000 mg/kg in tests for acute toxicity in rats,
- PB25 did not cause lethal effects after administration of a single
dermal dose of >= 2000 mg/kg to rats,
- PV032 is not irritating to the skin or the eyes and does not have to
be classified as eye or skin irritants,
- PV032 does not have to be classified as skin sensitizing based on the
findings in a Local Lymh Node Assays in mice,
- PR208 caused no systemic toxic effects, and no effects on fertility or development in a Combined Repeated Dose / Reproductive Toxicity Screening Test (OECD Guideline 422; NOAEL > 1000 mg/kg bw/day),
- The absence of adverse effects in the above-mentioned toxicity endpoint tests indicates that PV32 does not interact with living cells/tissues, and is not
- It is unlikely that PV32 become systemically bioavailable due to their extremely low solubility in water and low solubility in n-octanol. PV32 is not likely to be systemically available after oral, dermal or inhalation exposure.
Therefore no DNELs for systemic effects have been derived.
PV32 did 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 PV32 after local exposure, therefore no DNELs for local effects have been derived.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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