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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
7.84 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):
225
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOEAL of mg/kg bw/d is converted to a NOAEC by dividing by 0.38 and multiplying by 0.67 according to ECHA Guidance.
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28 days study.
AF for interspecies differences (allometric scaling):
1
Justification:
AF is not used for inhalation route.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available.
AF for intraspecies differences:
5
Justification:
For workers the default factor of 5 is used.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
3
Justification:
AF=2*1.5, where 2 refers to assumptions of 50% absorption by the oral route and 100% for the inhalation route. 1.5: Adjusted for light acitivity.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.84 mg/m³
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:
3.33 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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study is available. The ECHA Guidance default 100% absorption by both the oral and dermal route is used (conservative assessment).
AF for dose response relationship:
1
Justification:
NOAEL is used as starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28-dya study, sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rats are used in the animal test.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available
AF for intraspecies differences:
5
Justification:
For worker the default factor of 5 is used.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principle is used.
AF for remaining uncertainties:
1
Justification:
No further uncertainties to be taken into acccount.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
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

According to the results of toxicokinetic assessment, as there is no quantitative data available for dermal adsorption of test material, a worst case scenario is assumed in which the absorption rate from dermal route is considered to be same as oral route, and for both routes assumed to be 100%.As there is no quantitative data available for inhalative adsorption of the substance, a case is assumed in which the absorption rate oral (rat) / inhalation (human) = 50%/100% based on recommendation of ECETOC TECHNICAL REPORT NO. 110 (2010).

As basis for DNEL derivation the result from a sub-acute gavage study with rats was used. The results indicated a NOAEL > 1000 mg/kg bw/day (nominal). (Note: one female found dead in week one, but death was considered to be accidental.) The basis for the DNEL is oral NOAEL (1000 mg/kg bw/day) and NOAELcorr for the dermal route is still 1000 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalative NOAECworkerby dividing through 0.38 m3/kg and multiplying by 0.67 resulting in a NOAEC of 1763 mg/m3.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.93 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):
450
Modified dose descriptor starting point:
NOAEC
Value:
870 mg/m³
Explanation for the modification of the dose descriptor starting point:
The oral NOAEL of 1000 mg/kg bw/d is converted to a NOAEC by dividing by 1.15 according to ECHA Guidance
AF for dose response relationship:
1
Justification:
NOAEC is used as starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28-day study, sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
AF is not used for inhalation route.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available.
AF for intraspecies differences:
10
Justification:
For general population the default factor of 10 is used.
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principles is used.
AF for remaining uncertainties:
3
Justification:
AF=2*1.5, where 2 refers to assumptions of 50% absorption by the oral route and 100% for the inhalation route. 1.5: Adjusted for light acitivity.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.93 mg/m³
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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study is available. The ECHA Guidance default 100% absorption by both the oral and dermal route is used (conservative assessment).
AF for dose response relationship:
1
Justification:
NOAEL is used as starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28-day study, sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rats had been used as test animals.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available
AF for intraspecies differences:
10
Justification:
For general population the default factor of 10 is used
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principles is used.
AF for remaining uncertainties:
1
Justification:
No furhter uncerteainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 mg/kg bw/day
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:
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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
absorption rat = absorption human, no route-to-route extrapolation
AF for dose response relationship:
1
Justification:
NOAEL is used as starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28-day study.
AF for interspecies differences (allometric scaling):
4
Justification:
Rats were used in the animal study.
AF for other interspecies differences:
2.5
Justification:
No substance-specific data is available.
AF for intraspecies differences:
10
Justification:
for general population the default factor of 10 is used
AF for the quality of the whole database:
1
Justification:
Available data from substance fulfilling scientific principles is used.
AF for remaining uncertainties:
1
Justification:
No furhter uncerteainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 ng/kg bw/day
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

According to the results of toxicokinetic assessment, as there is no quantitative data available for dermal adsorption of test material, a worst case scenario is assumed in which the absorption rate from dermal route is considered to be same as oral route, and for both routes assumed to be 100%.As there is no quantitative data available for inhalative adsorption of the substance, a case is assumed in which the absorption rate oral (rat) / inhalation (human) = 50%/100% based on recommendation of ECETOC TECHNICAL REPORT NO. 110 (2010).

As basis for DNEL derivation the result from a sub-acute gavage study with rats was used. The results indicated a NOAEL > 1000 mg/kg bw/day (nominal). (Note: one female found dead in week one, but death was considered to be accidental.) The basis for the DNEL is oral NOAEL (1000 mg/kg bw/day) and NOAELcorr for the dermal route is still 1000 mg/kg bw/day. According to ECHA guidance document, the oral NOAEL of 1000 mg/kg bw/d is converted to an inhalative NOAEC (general population) by dividing by 1.15 according to ECHA Guidance resulting in a NOAEC of 870mg/m3.