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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.05 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):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
0.57 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhal NOAEC = 0.5 x (1/0.38) x (65/100) x (6.7/10) = 0.57 mg/m3

AF for dose response relationship:
1
Justification:
Clear overall NOAEL derivable.
AF for differences in duration of exposure:
1
Justification:
Based on a multigeneration study which produced the most sensitive NOAEL of all studies, including chronic. No adjustment required.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required because it is already taken into account when correcting for starting point.
AF for other interspecies differences:
5
Justification:
Default factor for workers.
AF for intraspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences.
AF for the quality of the whole database:
1
Justification:
The database is complete.
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.065 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):
50
Modified dose descriptor starting point:
NOAEL
Value:
3.25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal NOAEL = 0.5 x (65/10) = 3.25 mg/kg bw/day

AF for dose response relationship:
1
Justification:
Clear overall NOAEL derived.
AF for differences in duration of exposure:
1
Justification:
Based on a multigeneration study which produced the most sensitive NOAEL of all studies, including chronic. No adjustment required.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor in extrapolating from rat to man.
AF for other interspecies differences:
2.5
Justification:
Default factor for remaining interspecies differences.
AF for intraspecies differences:
5
Justification:
Default factor for workers.
AF for the quality of the whole database:
1
Justification:
The database is complete.
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

The material was not genotoxic and clear NOAELs were derived in repeat dose and reproductive toxicity studies. Looking across the rat, mouse and dog studies available (including chronic toxicity and carcinogenicity and reproductive and developmental toxicity) the overall NOAEL for all effects is 0.5 mg/kg bw/day, driven by convulsions in 1 litter of suckling pups in the 2 generation reproductive study at 5 mg/kg.

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

In accordance ECHA guidance (Chapter R.5: Adaptation of information requirements) no general population DNELs are set because there are no uses that would result in exposure of the general public.