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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
16.4 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 230 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default data well supported
AF for differences in duration of exposure:
6
Justification:
Default subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default scaling issues just evaluated in modified starting point
AF for other interspecies differences:
2.5
Justification:
Default remaining differences
AF for intraspecies differences:
5
Justification:
Default worker population
AF for the quality of the whole database:
1
Justification:
Default good quality and reliability
AF for remaining uncertainties:
1
Justification:
based on a worst-case approach, 100 % adsorption for inhalation route for human is assumed
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.67 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
other: modified NOAEL
Value:
1 400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default data well supported
AF for differences in duration of exposure:
6
Justification:
Default subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric factor rat to man
AF for other interspecies differences:
2.5
Justification:
Default remaining differences
AF for intraspecies differences:
5
Justification:
Default worker population
AF for the quality of the whole database:
1
Justification:
Default good quality and reliability
AF for remaining uncertainties:
1
Justification:
based on a worst-case approach, 100 % adsorption for dermal route for human is assumed
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
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The Derived No Effect Levels for both inhalation and dermal long-term exposure, systemic effects, are estimated from the No Observed Effect Level obtained from the combined repeated dose /reproductive-developmental toxicity experiment.

The NOAEL for repeated dose toxicity, as well as for both reproductive and developmental toxicity, was established as 1000 mg/kg body weight/day.

The calculation of DNELs is based on the NOAEL identified and has to be corrected for the differences between effect assessment data and the real human exposure situation, taking into account variability and uncertainty within and between species. In order to correct the interspecies difference between rat and human the no observed effect level has to be corrected, using the default values for DNEL calculation.

No DNEL is derived for dermal acute exposure, systemic effects, because dermal acute toxicity is not suspected (details in the acute toxicity endpoint summary). No DNEL is derived for inhalation acute exposure, systemic effects, because, based on the physical state of the substance under registration, inhalation is not an appropriate route of exposure.

Since no substance-related local effects were observed, only the DNELs for long-term systemic effects were derived. The substance is not classified for skin or eye irritation, thus an effect on mucous is not expected.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.47 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):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
370 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default data well supported
AF for differences in duration of exposure:
6
Justification:
Default subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default scaling issues just evaluated in modified starting point
AF for other interspecies differences:
2.5
Justification:
Default remaining differences
AF for intraspecies differences:
10
Justification:
Default general population
AF for the quality of the whole database:
1
Justification:
Default good quality and reliability
AF for remaining uncertainties:
1
Justification:
based on a worst-case approach, 100 % adsorption for inhalation route for human is assumed
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:
DNEL (Derived No Effect Level)
Value:
1.67 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

based on the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor should be introduced when performing oral-to-dermal extrapolation

AF for dose response relationship:
1
Justification:
Default data well supported
AF for differences in duration of exposure:
6
Justification:
Default subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric factor rat to man
AF for other interspecies differences:
2.5
Justification:
Default remaining differences
AF for intraspecies differences:
10
Justification:
Default general population
AF for the quality of the whole database:
1
Justification:
Default good quality and reliability
AF for remaining uncertainties:
1
Justification:
based on a worst-case approach, 100 % adsorption for dermal route for human is assumed
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
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

no default factor should be introduced when performing on the same route

AF for dose response relationship:
1
Justification:
Default data well supported
AF for differences in duration of exposure:
6
Justification:
Default subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric factor rat to man
AF for other interspecies differences:
2.5
Justification:
Default remaining differences
AF for intraspecies differences:
10
Justification:
Default general population
AF for the quality of the whole database:
1
Justification:
Default good quality and reliability
AF for remaining uncertainties:
1
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 Derived No Effect Levels for both inhalation and dermal long-term exposure, systemic effects, are estimated from the No Observed Effect Level obtained from the combined repeated dose /reproductive-developmental toxicity experiment.

The NOAEL for repeated dose toxicity, as well as for both reproductive and developmental toxicity, was established as 1000 mg/kg body weight/day.

The calculation of DNELs is based on the NOAEL identified and has to be corrected for the differences between effect assessment data and the real human exposure situation, taking into account variability and uncertainty within and between species. In order to correct the interspecies difference between rat and human the no observed effect level has to be corrected, using the default values for DNEL calculation.

No DNEL is derived for dermal acute exposure, systemic effects, because dermal acute toxicity is not suspected (details in the acute toxicity endpoint summary). No DNEL is derived for inhalation acute exposure, systemic effects, because, based on the physical state of the substance under registration, inhalation is not an appropriate route of exposure.

Since no substance-related local effects were observed, only the DNELs for long-term systemic effects were derived. The substance is not classified for skin or eye irritation, thus an effect on mucous is not expected.