Registration Dossier
Registration Dossier
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EC number: 604-314-4 | CAS number: 142844-00-6
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:
- DNEL (Derived No Effect Level)
- Value:
- 2.17 mg/m³
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor:
- NOAEC
- AF for differences in duration of exposure:
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 3
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 chemical substances from which this material is made are not themselves toxic. Any toxicity associated with this substance will be related to its fibrous morphology and not its chemical composition, which is relevant only to its biopersistence. Under normal handling and use this substance may produce fibrous dust capable of becoming airborne and then inhaled. The response to fibres in lung tissue is predominantly a function of fibre size and the quantity of fibres (dose). Fibres clear from the lung through breakage and dissolution, which are functions of biopersistence.
As with other vitreous fibres this material can cause acute mechanical irritation of the skin and eyes.
The DNEL cited in the long term inhalation exposure section above is based on the chronic multi-dose rat carcinogenicity study reported by Mast et al (Inhalation Toxicology, 1995, 7(4), 469-502) which demonstrates a NOAEL for lung cancer of 162 f/ml and leads to the calculated endpoint-specific DNEL of 2.17 f/ml.
SCOEL have recommended an OEL for RCF of 0.3 f/ml based on measured lung function in exposed workers. Assuming 45 years exposure, the average cumulative exposures of 147.9 (all workers in the high exposure group) and 184.8 fmo/ml (workers 60+ years of age in the high exposure group) - equivalent to average fibre concentrations of 0.27 and 0.34 f/ml - were considered as no observed adverse effect levels for lung function and SCOEL therefore proposed an OEL of 0.3 f/ml. This is considerably lower than the calculated DNEL value of 2.17f/ml.
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
This substance is restricted to professional use typically in industrial settings and exposure of the general population therefore does not occur.
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.
