Registration Dossier
Registration Dossier
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EC number: 266-046-0 | CAS number: 65997-17-3 This category encompasses the various chemical substances manufactured in the production of inorganic glasses. For purposes of this category, 'glass' is defined as an amorfous, inorganic, transparent, translucent or opaque material traditionally formed by fusion of sources of silica with a flux, such as an alkali-metal carbonate, boron oxide, etc. and a stabilizer, into a mass which is cooled to a rigid condition without crystallization in the case of transparent or liquid-phase separated glass or with controlled crystallization in the case of glass-ceramics. The category consists of the various chemical substances, other than by-products or impurities, which are formed during the production of various glasses and concurrently incorporated into a glass mixture. All glasses contain one or more of these substances, but few, if any, contain all of them. The elements listed below are principally present as components of oxide systems but some may also be present as halides or chalcogenides, in multiple oxidation states, or in more complex compounds. Trace amounts of other oxides or chemical compounds may be present. Oxides of the first seven elements listed* comprise more than 95 percent, by weight, of the glass produced. @Aluminium*@Lead@Boron*@Lithium@Calcium*@Manganese@Magnesium*@Molybdenum@Potassium*@Neodymium@Silicon*@Nickel@Sodium*@Niobium@Antimony@Nitrogen@Arsenic@Phosphorus@Barium@Praseodymium@Bismuth@Rubidium@Cadmium@Selenium@Carbon@Silver@Cerium@Strontium@Cesium@Sulfur@Chromium@Tellurium@Cobalt@Tin@Copper@Titanium@Germanium@Tungsten@Gold@Uranium@Holmium@Vanadium@Iron@Zinc@Lanthanum@Zirconium
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 20.1
- Dose descriptor:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
Workers - Hazard for the eyes
Additional information - workers
E-glass microfibre has potential to induce inflammation, fibrosis, adenomas, carcinomas and mesotheliomas in rats following 14 days, 90 days and long-term inhalation. Fibrosis, adenomas, carcinomas and mesotheliomas were induced in long-term inhalation studies at 1000 fibres/cm3whereas inflammation and fibrosis was induced in subacute (14-day) and subchronic (90-day) studies at dose levels of 15 fibres/cm3and 1000 fibres/cm3.
When the above mentioned assessment factor is applied to the derived LOAEL values, DNEL values ranging from 0.75 to 99.5 fibres/ cm3 can be derived. The lowest values are derived from the basis of a LOAEL for fibrosis, whereas the obtained DNEL value for carcinogenicity is 99.5 fibres/cm3.
A DNEL value instead of a DMEL value was derived based on a proposed non-genotoxic tumourigenetic action of E-glass microfibre. The tumourigenesis is probably due to irritation progressing into fibrosis with the further sequelae of tumour formation; i.e. a non-genotoxic action.If all derived DNEL values (see attached document) are used in a “meta-study” analysis a correlation can be established between inflammation, fibrosis and carcinogenicity using the observed effects at dose levels of 15 fibres/cm3and 1000 fibres/cm3. A factor of approximately 22 between the derived DNEL values from the subchronic and subacute studies can be established based on induction of inflammation and fibrosis (16.6/0.75). Using this factor for the long-term inhalation studies a DNEL value for carcinogenicity can be derived to be 4.5 (99.5/22). The derived DNEL value for induction of carcinogenicity could represent a relevant threshold value.
The relationship between fibrosis and development of lung carcinogenicity was recently discussed by an ILSI working group (ILSI, 2005). It was stated that all fibres that have caused cancer in animals via inhalation have also caused fibrosis at an earlier time point, i.e. after 3 month exposure.
Based on the information from the ILSI working group, stating a possible relationship between induction of fibrosis and development of lung carcinogenicity, it is evaluated that the lowest derived DNEL values from the subchronic toxicity study, which is based on induction of fibrosis, is relevant. Therefore it is evaluated that a derived DNEL of 0.75 fibres/cm3 for the worker can be established.
Furthermore, a possible threshold value of 4.5 for induction of carcinogenicity could be established using a “meta-study” analysis.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Most sensitive endpoint:
- carcinogenicity
DNEL related information
- Overall assessment factor (AF):
- 60
- Dose descriptor:
- LOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
E-glass microfibre has been shown to have a potential to induce inflammation, fibrosis, adenomas, carcinomas and mesotheliomas in rats following 14 days, 90 days and 12 months inhalation. Fibrosis, adenomas, carcinomas and mesotheliomas were induced in long-term inhalation studies at 1000 fibres/cm3whereas inflammation and fibrosis was induced in subacute (14-day) and subchronic (90-day) studies at a lower dose level of 15 fibres/cm3and at 1000 fibres/cm3.
When the above mentioned assessment factor is applied to the derived LOAEL values, DNEL values ranging from 0.25 to 33.4 fibres/ cm3can be derived. The lowest DNEL value are derived from the basis of a LOAEL for fibrosis obtained in a subchronic (90-day)study, whereas the obtained DNEL value for carcinogenicity is 33.4 fibres/cm3.
If all derived DNEL values (see attached document) are used in a “meta-study” analysis a correlation can be established between inflammation, fibrosis and carcinogenicity using the observed effects at dose levels of 15 fibres/cm3and 1000 fibres/cm3. A factor of approximately 22 between the derived DNEL values from the subchronic and subacute studies can be established based on induction of inflammation and fibrosis (16.6/0.75). Using this factor for the long-term inhalation studies a DNEL value for carcinogenicity can be derived to be 4.5 (99.5/22). The derived DNEL value for induction of carcinogenicity could represent a relevant threshold value.
The relationship between fibrosis and development of lung carcinogenicity was recently discussed by an ILSI working group (ILSI, 2005). It was stated that all fibres that have caused cancer in animals via inhalation have also caused fibrosis at an earlier time point, i.e. after 3 months exposure.
Based on the information from the ILSI working group, stating a possible relationship between induction of fibrosis and development of lung carcinogenicity, it is evaluated that the lowest derived DNEL values from the subchronic study, which is based on induction of fibrosis, is relevant. Therefore it is evaluated that a derived DNEL of 0.25 fibres/cm3 for the general population can be established. Furthermore, a possible threshold value of 4.5 for induction of carcinogenicity can be established using a “meta-study” analysis.
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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