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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
421 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
5 263 mg/m³
Explanation for the modification of the dose descriptor starting point:
Used 1/0.38 for respiratory volume rat to humans (8 hr); 6.7/10 for respiratory volume standard human to worker (8 hr)
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
Justification:
Sub chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
See above
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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)
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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

1. Overview of typical dose descriptors for all endpoints

Repeated dose:  90 day dietary study in rats NOAEL > 4257 mg/kg/bw/day. No treatment related effects were seen at highest dose tested.(Sci Assoc. 1966a) Reproductive effects: OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested. Developmental effects: OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested.

Selection of study upon which to base the DNEL: OECD 422 dietary study in rats NOAEL of > 2000 mg/kg bw/day. No treatment related effects were seen at highest dose tested. 

DNEL (Worker) dermal > 40 mg/kg/day.

DNEL (Worker) Inhalation > 421 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
69.57 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
1 739 mg/m³
Explanation for the modification of the dose descriptor starting point:
Used 1/1.15 for respiratory volume rat to humans (24 hr);
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
See above
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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:
20 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
4
Justification:
default
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default
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:
20 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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

1. Overview of typical dose descriptors for all endpoints

Repeated dose:  90 day dietary study in rats NOAEL > 4257 mg/kg/bw/day. No treatment related effects were seen at highest dose tested.(Sci Assoc. 1966a) Reproductive effects: OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested. Developmental effects:OECD 422 (dietary) study in rats NOAEL of > 2000 mg /kg bw/day. No treatment related effects were seen at highest dose tested.

Selection of study upon which to base the DNEL: OECD 422 dietarystudy in rats NOAEL of > 2000 mg/kg bw/day. No treatment related effects were seen at highest dose tested. 

DNEL (oral, consumer):> 20 mg/kg/day.

DNEL (dermal, consumer):> 20 mg/kg/day

DNEL (inhalation, consumer) > 69.57 mg/m3