Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No DNEL calculated. DNEL for long-term local effects considered to also protect against long-term systemic effects.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No DNEL calculated. Due to the corrosive properties an acute inhaltion toxicity study was not performed. The conservative acute DNEL for inhalation local effects is regarded to ensure sufficient protection also against acute systemic inhalative effects.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: VCI inhalation DNEL for corrosive substances
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: VCI inhalation DNEL for corrosive substances
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Qualitative risk assessment was carried out based on corrosivity.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
Qualitative risk assessment was carried out based on corrosivity.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Worker DNEL: Long-term/acute for inhalation route, local effects
The German VCI ("Verband der chemischen Industrie") established an inhalation DNEL for local effects for corrosive substances of 1 mg/m3 that should be applied for long- and short-term exposure equally.
The derivation of this value is fully described in Messinger (2014). Briefly, the DNEL is a generic cut-off value based on an extensive analysis of the German occupational exposure limit (OEL) values as published in TRGS 900 (“Technnische Regeln für Gefahrstoffe”) for substances that are legally classified as corrosive. Overall, the applicability domain of the DNEL of 1 mg/m3 for corrosive substances is defined as follows (Messinger, 2014):
- The substance is not a CMR substance, not a heavy metal derivative, not a sensitiser and does not hydrolyse to strong acids/bases
- The substance is not very toxic by ingestion, dermal contact or inhalation.
The submission substance fulfils these criteria and the DNEL of 1 mg/m3 can be applied.
Reference
Messinger, H. (2014): An approach for the delineation of a generic cut-off value for local respiratory tract irritation by irritating or corrosive substances as a pragmatic tool to fulfill REACH requirements, Regulatory Toxicology and Pharmacology, 3, 317-324
The substance is classified for human health as corrosive to the skin (and assumed corrosive to the eye). The hazard statement H314: Causes severe skin burns and eye damage, is applicable.
No DNEL for systemic effects is derived since the corrosive properties of the substance determine the hazard and risk profile. Otherwise, dermal systemic exposure would have to be calculated, which would then assume (even if gloves are worn) some dermal exposure to the substance. This cannot reflect the real situation since the skin would suffer from the corrosive effects. Rather than calculating some dermal exposure potentially leading to systemic effects and discounting these results afterwards on the basis of the corrosive effects, it is more appropriate to base the dermal assessment entirely on the qualitative risk characterisation for a corrosive substance. Based on the classification and the hazard statement a high hazard band for the qualitative assessment is assumed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
Step2 catalyst is not used in the consumer sector. DNEL derivations for the general population is therefore not necessary and not required. Consideration of indirect exposures via the environment is not requiered as the substance is also used under strictly controlled conditions and no release to the environment is foreseen.
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.
