Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEC
Value:
31.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human"

Justification:
Subacute -> chronic
Justification:
Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
Justification:
Default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
DNEL (Derived No Effect Level)
Value:
0.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEL
Value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).

Justification:
Subacute -> chronic
Justification:
Rat-> human; Default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
DNEL (Derived No Effect Level)
Value:
0.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEC
Value:
15.75 mg/m³
Explanation for the modification of the dose descriptor starting point:

The route to route extrapolation was conducted according to Appendix R8.2 of the ECHA Guidance document "Chapter R.8: Characterisation of dose [concentration]-response for human"

Justification:
Subacute->chronic, default value according to ECHA REACH Guidance
Justification:
Still applied by route to route extrapolation for deriving NOAEC by using allometric scaling
Justification:
Default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
DNEL (Derived No Effect Level)
Value:
0.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEL
Value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The route to route extrapolation was conduted according to Health Risk Assessment Guidance for Metals (HERAG).

Justification:
subacute->chronic
Justification:
rat-> human, default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Modified dose descriptor starting point:
NOAEL
Value:
18 mg/kg bw/day
Justification:
Subacute->chronic
Justification:
Rat->human, default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
Justification:
Default value according to ECHA REACH Guidance
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