Registration Dossier

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:
0.075 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
DNEL value:
1.5 mg/m³
AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEC. Thus, the default assessment factor for dose response relationship is 1 according to Guidance Document R.8.4.3.1 (ECHA, 2015).
AF for differences in duration of exposure:
2
Justification:
An assessment factor 2 is suggested by Guidance Document R.8 (Table R.8-5, ECHA, 2015) for exposure duration from sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
According to the Guidance Document R.8 (ECHA, 2015) allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, e.g. in the case of local effects. In case of this substance none of the available studies (acute and short term repeated dose toxicity, Irritation/Corrosion, Sensitisation) give indications of systemic bioavailability, since no systemic toxicity (or sensitisation potential) was observed. Instead, a particle-related portal of entry toxicity as toxicological mode of action is assumed. Therefore AF 1 is chosen.
AF for other interspecies differences:
1
Justification:
A factor of 2.5 is suggested by Guidance Document R.8 (ECHA, 2015) for remaining interspecies differences, but justified deviations are possible. The available sub-chronic inhalation study with the substance supports local particle-related portal of entry toxicity as toxicological mode of action. For local effects on the respiratory tract it should be taken into account that rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. In fact, the relevance of local portal-of-entry related effects seen in the lungs of animals for humans is currently not clear and is subject to continued scientific debate (cp. Guidance on the application of the CLP criteria, ECHA, 2015). However, it is not indicated that humans are more susceptible against these kinds of effects, therefore a factor of 1 is applied.
AF for intraspecies differences:
5
Justification:
For intraspecies variability in workers the default assessment factor is 5 according to Guidance Document R.8 (ECHA, 2015)
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied for good/standard quality of the data base is 1.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.375 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

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

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:
DNEL (Derived No Effect Level)
Value:
0.013 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor:
NOAEC
DNEL value:
0.15 mg/m³
AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEC. Thus, the default assessment factor is 1 according to Guidance Document R.8 (ECHA, 2015).
AF for differences in duration of exposure:
2
Justification:
An assessment factor 2 is suggested by Guidance Document R.8. (Table R.8-5, ECHA, 2015) for exposure extrapolation from subchonic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
According to the Guidance Document R.8 (ECHA, 2015) allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, e.g. in the case of local effects. In case of this substance none of the available studies (acute and short term repeated dose toxicity, Irritation/Corrosion, Sensitisation) give indications of systemic bioavailability, since no systemic toxicity (or sensitisation potential) was observed. Instead, a particle-related portal of entry toxicity as toxicological mode of action is assumed. Therefore AF 1 is chosen.
AF for other interspecies differences:
1
Justification:
A factor of 2.5 is suggested by Guidance Document R.8 (ECHA, 2015) for remaining interspecies differences, but justified deviations are possible. The available sub-chronic inhalation study with the substance supports local particle-related portal of entry toxicity as toxicological mode of action. For local effects on the respiratory tract it should be taken into account that rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. In fact, the relevance of local portal-of-entry related effects seen in the lungs of animals for humans is currently not clear and is subject to continued scientific debate (cp. Guidance on the application of the CLP criteria, ECHA, 2015). However, it is not indicated that humans are more susceptible against these kinds of effects, therefore a factor of 1 is applied.
AF for intraspecies differences:
10
Justification:
For intraspecies variability in the general population the default assessment factor is 10 according to Guidance Document R.8 (ECHA, 2015).
AF for the quality of the whole database:
1
Justification:
The default assessment factor to be applied for good/standard quality of the database is 1.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.065 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

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

The use of the test substance is restricted only to industrial applications. A direct use of this substance is not known. The exposure of consumers to this substance is unlikely to occur via consumer products, because no consumer product is known to contain this substance. Furthermore, because there is no release into the environment, an indirect exposure of the general population via the environment does not occur.