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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.1 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
2.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
1.5 mg/kg x [1/0.38 x 100/100 x 6.7/10] = 2.6 mg/m3
AF for dose response relationship:
1
Justification:
None required. A clear NOAEL was derived.
AF for differences in duration of exposure:
1
Justification:
None required. The study may be considered a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required after correcting starting point from oral to inhalation .
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences.
AF for intraspecies differences:
5
Justification:
Default factor for workers.
AF for the quality of the whole database:
2
Justification:
The full complement of reprotoxicity and genotoxicity studies needs to be completed.
AF for remaining uncertainties:
1
Justification:
None required. There were no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
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:
0.06 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):
100
Modified dose descriptor starting point:
NOAEL
Value:
6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
1.5 mg/kg bw/day x [ 100/25] = 6 mg/kg bw/day
AF for dose response relationship:
1
Justification:
None required. A clear NOAEL was derived.
AF for differences in duration of exposure:
1
Justification:
None required. The study may be considered a chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Default extrapolation factor from rat to man.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining differences
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for the quality of the whole database:
2
Justification:
The full complement of reprotoxicity and genotoxicity studies needs to be completed.
AF for remaining uncertainties:
1
Justification:
None required. There were no remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

An acute oral toxicity study, a chronic toxicity study and genotoxicity data are available. The material is acutely toxic (200< LD50 < 2000 mg/kg bw). A conservative chronic NOAEL was derivable from the 2 year rat study at 1.5 mg/kg bw/day. The material was not genotoxic in an in vitro chromosome aberration assay.

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:
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:
no hazard identified
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:
no hazard identified
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