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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.47 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
70 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
sub-acute to sub-chronic
AF for interspecies differences (allometric scaling):
1
Justification:
included in respiratory volume
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default for worker
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
0.034 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
NOAEC
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
sub-acute to sub-chronic
AF for interspecies differences (allometric scaling):
1
Justification:
included in respiratory volume
AF for other interspecies differences:
1
Justification:
the local effect on macrophages is not considered to impose additional interspecies differences (see comment)
AF for intraspecies differences:
5
Justification:
ECHA default for worker
AF for the quality of the whole database:
1
AF for remaining uncertainties:
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

In a 28 -day repeated dose inhalation toxicity study, the authors considered effects at 2 mg/m3to be the lowest observed adverse effect concentration (LOAEC), even though this dose “appears to be close to a physiological tolerable challenge in rats”. Due to the physiological differences between human and rat (higher number of macrophages in humans, difference in airway geometry and higher sensitivity to particle effects in rats), this value can be considered “no observed adverse effect” in human. In addition, it seems to be justified to omit the assessment factor for inter-species differences as the effect is limited to the alveolar macrophages and thus can be considered a local effect. The standard assessment factor of x 2.5 for remaining uncertainty would predominantly be assigned to systemic effects and thus would not be applicable here.

Under these considerations, the DNEL (worker, local, long-term) is 0.034 mg/m3. Details of the method and default values for deriving DNELs are illustrated in the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8.

The corrected NOAEC was calculated with the following values: NOAEC (2 mg/m3); Absorption inhalation rat = Absorption inhalation human; sRV(human)/wRV = 6.7 m3/10 m3; exposure duration (study = 6h; worker = 8h).

In addition, a DNEL (worker, systemic, long-term) of 0.47 mg/m3was derived based on the lack of systemic toxicity at the maximum concentration attainable in the OECD 412 study (NOEAL of 70 mg/m3). This DNEL could be omitted based on the lack of systemic toxicity by inhalation exposure. It was just calculated as a reference value for comparing local vs systemic effects. The risk assessment is based on local effects in the lung.

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
AF for dose response relationship:
1
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1

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

Substance is only used in industrial and professional settings.