Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3.35
Dose descriptor:
NOAEC
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, irritation 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 3.35; 0.67 for correction of experimental to human exposure conditions, and AF 5 for intraspecies (workers), leading the a DNEL for workers of 0.9 mg/m3, corresponding to 10.1 fibres per cm3. 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:
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

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, irritation 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 with fibrosis endpoint. The NOAEL for fibrosis, was 3.1 mg/m3 (corresponding to 34 fibres per cm3), with the assessment factor 10 ; 1 for correction of experimental to human exposure conditions, and AF 10 for intra species (general public), leading the a DNEL for general public of 0.3 mg/m3, corresponding to 0.34 fibres per cm3. This DNEL was suggested for the Chemical Safety Assessment.