Registration Dossier
Registration Dossier
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EC number: 944-232-9 | CAS number: -
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
No acute systemic DNELs or long-term systemic DNELs or local inhalation DNELs have been derived because the substance is not classified for acute toxicity, repeated dose toxicity, reproductive/developmental toxicity or for local effects following inhalation.
The substance is classified as a skin sensitiser Category 1B therefore a moderate hazard is assigned according to ECHA CSA Guidance Part E Table E 3 -1. Considering that there are no dose response data for this endpoint, a qualitative risk characterisation has been conducted for acute and long-term local dermal effects.
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:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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
The substance is classified as a skin sensitiser Category 1B therefore a moderate hazard is assigned according to ECHA CSA Guidance Part E Table E 3 -1 for handling of the test substance. However, the test substance itself is not handled by the consumer as due to the complicated dyeing process, home-dyeing is not applicable for the use of this substance. The dye is applied in its reduced water-soluble form. During the dyeing process, the test substance is physically bound to the textile fibre and fixed by oxidation to the insoluble vat form. It is therefore unlikely that the consumer is exposed to the dye from contact with the dyed textile. With the modern dyeing process a fixation rate of at least 90% is reached. The dye is bound extremely well to the fabric, so that no migration from the textiles is expected. The fastness properties of the vat dyed articles are extremely good. They are hence standard for textiles used in medical laboratories and clinics. Significant consumer exposure to the test substance is therefore not expected. Consequently, the hazard conclusion is set to low for the consumer. Considering that there are no dose response data for this endpoint, a qualitative risk characterisation has been conducted for acute and long-term local dermal effects.
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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