Registration Dossier
Registration Dossier
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EC number: 234-919-5 | CAS number: 12040-43-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.29 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEC
- Value:
- 16.13 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Key, Creutzenberg, 2014, OECD 413, SAS, RL1
Due to the particle size distribution in the test medium the nominal concentration was 16.13 mg/m³, to achieve 5 mg/m³ aerosol test concentration.
This results in a NOAEL > 5 mg/m³ air corresponding to > 16.13 mg/m³ nominal concentration in air for NM-200 which is taken as a worst-case approach for SMAS. Worst case is justified based on the nine-times higher solubility of the SMAS in comparison to test item NM-200 (SAS). This suggests that a NOAEL for SMAS will be much higher (200 mg/m³).
- AF for other interspecies differences:
- 2.5
- Justification:
- According ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, table R. 8-6 Default assessment factors, page 32, 2012 (Reference: ECHA-2010-G-19-EN)
- AF for intraspecies differences:
- 5
- Justification:
- According ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, table R. 8-6 Default assessment factors, page 32, 2012 (Reference: ECHA-2010-G-19-EN)
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
The past and ongoing medical investigation provides no evidence of substance induced health effects, in particular by repeated inhalation or skin contact for workers on manufacturing plants.
For applicants the values for inhalable dusts are below the limits of 10 mg/m³, the values for respirable are below the limits of 5 mg/m³ with exception for the mixers and the values for respirable quartz are below the limits of 75 µg/m³.
No poisoning incidents with substance are known; substance is used in industrial settings for several decades.
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
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.
