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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
no hazard identified
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:
0.03 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
15
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
Conversion from LOAEC to NOAEC
AF for differences in duration of exposure:
1
Justification:
due to local effects in lung, seen in chronic as well as subchronic studies
AF for interspecies differences (allometric scaling):
1
Justification:
derived from inhalation study
AF for other interspecies differences:
1
Justification:
remaining differences not given since similar effects were observed in monkeys and rats
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
1
Justification:
DNEL derived from guideline study RL 1
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
12.5 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is conducted in accordance with ECHA Practical Guide 14, Table 2 for route to route extrapolation by applying the following equation: Dermal NOAEL = (oral NOAEL)*( ABSoral/ABSdermal). Based on the inorganic nature of the substance, its molecular weight of ca. 1120-18165 g/mol and is insolubility in n-octanol, dermal absorption is considered to be lower than oral absorption. A default value of 10% dermal absorption is taken as a sufficiently conservative estimate. Hence, dermal NOAEL = [corrected NOAEL] *( ABSoral/ABSdermal) = (250 mg/kg bw/day)*(100/10) = 2500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
DNEL is based on NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on study conducted in rats
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
2
Justification:
DNEL is based on read-across from a structural analogue
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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

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

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.015 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
Conversion from LOAEC to NOAEC
AF for differences in duration of exposure:
1
Justification:
due to local effects in lung seen in chronic as well as subchronic studies
AF for interspecies differences (allometric scaling):
1
Justification:
derived from inhalation study
AF for other interspecies differences:
1
Justification:
remaining differences not given since similar effects were observed in monkey and rats
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
DNEL derived from guideline study RL1
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
6.25 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):
400
Modified dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Route-to-route extrapolation is conducted in accordance with ECHA Practical Guide 14, Table 2 for route to route extrapolation by applying the following equation: Dermal NOAEL = (oral NOAEL)*( ABSoral/ABSdermal). Based on the inorganic nature of the substance, its molecular weight of ca. 1120-18165 g/mol and is insolubility in n-octanol, dermal absorption is considered to be lower than oral absorption. A default value of 10% dermal absorption is taken as a sufficiently conservative estimate. Hence, dermal NOAEL = [corrected NOAEL] *( ABSoral/ABSdermal) = (250 mg/kg bw/day)*(100/10) = 2500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
DNEL is based on NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on study conducted with rats
AF for other interspecies differences:
2.5
Justification:
remaining differenes
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
2
Justification:
DNEL is based on a read-across from a structural analogue
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
DNEL (Derived No Effect Level)
Value:
0.625 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):
400
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
DNEL is based on NOAEL
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a 90-day study
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on study conducted with rats
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
2
Justification:
DNEL is based on read-across from structural analogue
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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