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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.235 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):
375
Modified dose descriptor starting point:
NOAEC
Value:
88.2 mg/m³
Explanation for the modification of the dose descriptor starting point:
A key oral 28-day toxicity study is available; there was no repeated dose inhalation toxicity study.
AF for dose response relationship:
1
Justification:
ECHA default factor
AF for differences in duration of exposure:
6
Justification:
ECHA default for subacute test
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already applied in route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
ECHA default factor
AF for intraspecies differences:
5
Justification:
ECHA default factor
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
5
Justification:
In absence of a reproduction toxicity screening study, a factor 5 was applied.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
0.333 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):
1 500
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A key oral 28-day toxicity study is available; there was no repeated dose dermal toxicity study.
AF for dose response relationship:
1
Justification:
ECHA default factor
AF for differences in duration of exposure:
6
Justification:
ECHA default factor for subacute test.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is already applied in route to route extrapolation.
AF for other interspecies differences:
10
Justification:
ECHA default. For more information check ECHA R8, 2012 pg 23-45
AF for intraspecies differences:
5
Justification:
ECHA default factor
AF for the quality of the whole database:
1
Justification:
No indication that a factor for quality is needed
AF for remaining uncertainties:
5
Justification:
In absence of a reproduction toxicity screening study, a factor 5 was applied.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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

No quantitative dose-response data are available for local effects on skin and respiratory tract. The substance is not irritating or sensitising in animal experiments.

The long-term dermal DNEL for systemic effects is based on the 28 -day feeding study in rats (NOAEL = 50 mg/kg bw/day). Using the available physical and chemical properties (see chapter 4 in the IUCLID file) the permeability constant (Kp) was predicted with the QSAR application DERMWIN v2.00. By applying the principles described in Kroes et al. 2007 on the expected skin permeation rate of a substance, a dermal absoption rate of 10% was predicted.

The long-term inhalation DNEL for systemic effects is based on the 28 -day feeding study in rats (NOAEL = 50 mg/kg bw/day). The starting point was corrected using the 10 m³ breathing volume per 8-h shift with light physical activity.

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

No exposure to general population.