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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:
0.18 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):
15
Dose descriptor starting point:
LOAEL
Value:
2.1 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
2.69 mg/m³
Explanation for the modification of the dose descriptor starting point:

Applying the standard values taken from ECHA Guidance R.8, the following apply: 


respiratory volume rat: 2.2 L/h, body weight 25 g (values for females represent worst-case approach)


This can be converted to 0.704 m3/kg bw in 8h


Taking into consideration the oral and inhalation absorption values specified in IUCLID section 7.1, a corrected LOAEC of 2.69 mg/m3 is derived.

AF for dose response relationship:
3
Justification:
Default for use of LOAEL as starting point
AF for differences in duration of exposure:
1
Justification:
Default for use of chronic study as starting point
AF for interspecies differences (allometric scaling):
1
Justification:
Default for derivation of inhalation DNEL
AF for other interspecies differences:
1
Justification:
Data on multiple species available, show that mouse is clearly the most sensitive species and LOAEL is worst-case POD for risk assessment
AF for intraspecies differences:
5
Justification:
Default according to ECHA guidance R.8
AF for the quality of the whole database:
1
Justification:
Default for use of OECD guideline and GLP study
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:
36 µg/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):
105
Dose descriptor starting point:
LOAEL
Value:
2.1 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
3.78 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Taking into consideration the oral and dermal absorption rates (as specified in IUCLID section 7.1) and using the oral NOAEL of 2.1 mg/kg bw/d as starting point, a corrected NOAEL of 3.78 mg/kg bw/d can be derived.

AF for dose response relationship:
3
Justification:
Default for use of LOAEL as starting point
AF for differences in duration of exposure:
1
Justification:
Default for use of chronic study as starting point
AF for interspecies differences (allometric scaling):
7
Justification:
Default for mouse - human extrapolation
AF for other interspecies differences:
1
Justification:
Data on multiple species available, show that mouse is clearly the most sensitive species and LOAEL is worst-case POD for risk assessment
AF for intraspecies differences:
5
Justification:
Default according to ECHA Guidance R.8
AF for the quality of the whole database:
1
Justification:
Default for use of OECD guideline and GLP study as starting point
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:
hazard unknown but no further hazard information necessary as no exposure expected
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:
hazard unknown but no further hazard information necessary as no exposure expected
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:
other toxicological threshold
Value:
10 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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