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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.18 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