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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.526 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
264.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
No data on testing of inhalation toxicity is available, thus extrapolation from oral route is applicable.
AF for dose response relationship:
1
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for differences in duration of exposure:
6
Justification:
Default value according to ECHA REACH Guidance R.8.
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for intraspecies differences:
5
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for the quality of the whole database:
1
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for remaining uncertainties:
2.5
Justification:
Default value according to ECHA REACH Guidance R.8.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEL
Value:
3 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No data on testing of long-term dermal toxicity is available, thus extrapolation from oral route is applicable.
AF for dose response relationship:
1
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for differences in duration of exposure:
6
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for other interspecies differences:
1
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for intraspecies differences:
5
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for the quality of the whole database:
1
Justification:
Default value according to ECHA REACH Guidance R.8.
AF for remaining uncertainties:
2.5
Justification:
Default value according to ECHA REACH Guidance R.8.
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
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:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Since consumer uses are not foreseen, a derivation of consumer DNEL is not applicable.