Registration Dossier
Registration Dossier
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EC number: 926-771-1 | 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:
- DNEL (Derived No Effect Level)
- Value:
- 2.24 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 7.5
- Dose descriptor:
- NOAEC
- Value:
- 3.1 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 1
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 1
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
Due to the inert/inorganic nature of the FMMVF fibres, no systemic effects are expected. From the experimental studies investigated no systemic effects have been described. The local dermal effect, is of a reversible mechanical nature. This does not result in a classification, cf. Regulation (EC) 1272/2008 (1. ATP in Regulation (EC) 790/2009) as irritant. The only relevant exposure route is via inhalation. In the experimental data, no significant evidence were found for a carcinogenic effect, thus the highest dose tested can be considered NOAEL. Another NOAEL for fibrosis, was obtained from the same experiment, Effect level was 3.1 mg/m3 (corresponding to 34 fibres per cm3), with the assessment factor 7.5; 0.67 for correction of experimental to human exposure conditions, and AF 3 for intraspecies (workers), leading the a DNEL for workers of 0.2 mg/m3, corresponding to 2.24 fibres ml. This DNEL was suggested for the Chemical Safety Assessment.
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:
- hazard unknown but no further hazard information necessary as no exposure expected
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
Due to the inert/inorganic nature of the FMMVF fibres, no hazards associated with systemic toxicity are expected and from the experimental studies investigated no systemic effects have been described. The DNEL for workers is based on a local inhalation effect, primarily related to the physical form of the fibre substance and not its systemic toxicity. The only relevant exposure route is therefore via direct inhalation of the fibres themselves. It is not possible for this exposure to be expressed once the substance is bound into article form (the only source of consumer contact) and it is not possible for this exposure to be expressed as man via the environment since the substance will no longer be present in the same fibre dimensions once it has been through environmental processes and won’t be airborne for inhalation exposure to be a possibility.
Therefore exposure assessment and risk characterisation are not required for man via the environment as no hazard has been identified for long term systemic effects.
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