Registration Dossier
Registration Dossier
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EC number: 213-879-2 | CAS number: 1047-16-1
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 mg/m³
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
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
Acute / short-term dermal exposure - systemic effects
Acute / short-term inhalation exposure - systemic effects
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 >2000 mg/kg bw; LC50 inhalation > 3.1 mg/L) and no hazards leading to classification and labeling were identified. It is considered unlikely that the registration substance becomes systemically bioavailable after dermal or inhalation exposure.
Acute / short term dermal exposure - local effects
Acute / short term inhalation exposure - local effects
Worker DNELs for acute exposure - local effects are not derived, because the registration substance has 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. Apart from that, relevant occupational exposure limits for inert dusts should be applied (see below for justification).
Long-term dermal exposure - systemic effects
Based on the fact that the test item did not cause adverse effects in any of the available studies, the test material is considered an inert dust without any chemical specific activity. This notion is supported by the physcio-chemical properties (extremely poor solubility) of the test material.
No adverse effects are expected from an insoluble solid on the skin (local) nor any absorption (systemic)
Long-term inhalation exposure - systemic effects
Based on the fact that the test item did not cause adverse effects in any of the available studies, the test material is considered an inert dust without any chemical specific activity. It is considered unlikely that Piment Violet 19 becomes systemically bioavailable after oral, dermal or inhalation exposure. The main hazard results if dusty material is inhaled at doses at which the natural clearance function of the lung is overloaded. To protect against, the general exposure limit for inhalable inert dust at the workplace (3 mg/m³) is applied as a surrogate DNEL. It is maintained in the section of local effects. If this limit is not exceeded no adverse effects are expected even after prolonged exposure.
Long-term dermal exposure - local effects
A DNEL is not derived because the registration substance 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
The registration substance does not cause irritation, corrosion or sensitization and no data for setting a worker DNEL "long-term inhalation exposure -local effects" are available. Based on the physico-chemical properties and the results of toxicity testing it can reasonably be assumed that the substance, when aerosolized in respirable form, will behave like an inert dust. Inert dusts can exert local effects in the lung and, therefore, 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
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
There is no exposure of the general population to the pure pigment powder. In all resonablly expected situations the pigment will be tightly bound in a matrix.
Acute / short-term dermal exposure - systemic effects
Acute / short-term inhalation exposure - systemic effects
General population DNELs for acute exposure - systemic effects are not derived, because no relevant acute toxicity was observed (LD50 oral >2000 mg/kg bw; LD50 dermal >2000 mg/kg bw; LC50 inhalation >3.1 mg/L) and no hazards leading to classification and labeling were identified. It is considered unlikely that the registration substance becomes systemically bioavailable after dermal or inhalation exposure.
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 the registration substancehas 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. Finaly, there is no exposure of the general population to the pure pigment powder. In all resonablly expected situations the pigment will be tightly bound in a matrix.
Long-term dermal exposure - systemic effects
Based on the fact that the test item did not cause adverse effects in any of the available studies, the test material is considered an inert dust without any chemical specific activity. This notion is supported by the physcio-chemical properties (extremely poor solubility) of the test material.
No adverse effects are expected from an insoluble solid on the skin (local) nor any absorption (systemic)
Long-term inhalation exposure - systemic effects
Based on the fact that the test item did not cause adverse effects in any of the available studies, the test material is considered an inert dust without any chemical specific activity
It is considered unlikely that Piment Violet 19 becomes systemically bioavailable after oral, dermal or inhalation exposure. There is no exposure of the general population to the pure pigment powder. In all resonablly expected situations the pigment will be tightly bound in a matrix.
Long-term dermal exposure - local effects
A DNEL is not derived because the registration substance does not cause irritation, corrosion and/or sensitization.
Long-term inhalation exposure - local effects
Based on the fact that the test item did not cause adverse effects in any of the available studies, the test material is considered an inert dust without any chemical specific activity
It is considered unlikely that Piment Violet 19 becomes systemically bioavailable after oral, dermal or inhalation exposure.There is no exposure of the general population to the pure pigment powder. In all resonablly expected situations the pigment will be tightly bound in a matrix.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
