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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
43.7 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:
1 093.15 mg/m³
Explanation for the modification of the dose descriptor starting point:
For repeated dose toxicity only an oral subchronic study is available The starting point was corrected according to Figure R.8-3 in chapter R.8 in the ECHA guidance document (version 2.1, November 2012). It is assumed that the inhalation absorption in human is similar to the oral absorption in rat.
AF for dose response relationship:
1
Justification:
Only effects on liver weights in females at the highest applied dose were observed without pathological findings
AF for differences in duration of exposure:
2
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling: rat versus human the AF of 4 is already included in the route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default value (ECHA)
AF for intraspecies differences:
5
Justification:
Default value (ECHA)
AF for the quality of the whole database:
1
Justification:
Default value (ECHA) - study comparable to guideline study
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
other: No DNEL derived because no hazard identified

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:
6.2 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:
620 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long-term dermal toxicity study available. The derivation of a DNEL for dermal toxicity from a long-term oral study is approved by ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health , Version 2.1
AF for dose response relationship:
1
Justification:
Only effects on liver weights in females at the highest applied dose were observed without pathological findings
AF for differences in duration of exposure:
2
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (ECHA)
AF for other interspecies differences:
2.5
Justification:
Default value (ECHA)
AF for intraspecies differences:
5
Justification:
Default value (ECHA)
AF for the quality of the whole database:
1
Justification:
Default value (ECHA) - study comparable to guideline study
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

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:
DNEL (Derived No Effect Level)
Value:
10.8 mg/m³
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
539.13 mg/m³
Explanation for the modification of the dose descriptor starting point:
The starting point was corrected according to Figure R.8-3 in chapter R.8 in the ECHA guidance document (version 2.1, November 2012). It is assumed that the inhalation absorption in human is similar to the oral absorption in rat.
AF for dose response relationship:
1
Justification:
Only effects on liver weights in females at the highest applied dose were observed without pathological findings
AF for differences in duration of exposure:
2
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling: rat versus human the AF of 4 is already included in the route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
Default value (ECHA)
AF for intraspecies differences:
10
Justification:
Default value (ECHA)
AF for the quality of the whole database:
1
Justification:
Default value (ECHA) - study comparable to guideline study
AF for remaining uncertainties:
1
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:
DNEL (Derived No Effect Level)
Value:
3.1 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
620 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No long-term dermal toxicity study available. The derivation of a DNEL for dermal toxicity from a long-term oral study is approved by ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterization of dose [concentration]-response for human health , Version 2.1
AF for dose response relationship:
1
Justification:
Only effects on liver weights in females at the highest applied dose were observed without pathological findings
AF for differences in duration of exposure:
2
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (ECHA)
AF for other interspecies differences:
2.5
Justification:
Default value (ECHA)
AF for intraspecies differences:
10
Justification:
Default value (ECHA)
AF for the quality of the whole database:
1
Justification:
Default value (ECHA) - study comparable to guideline study
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.1 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):
200
Modified dose descriptor starting point:
NOAEL
Value:
620 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable – long term oral study is used for DNEL derivation
AF for dose response relationship:
1
Justification:
Only effects on liver weights in females at the highest applied dose were observed without pathological findings
AF for differences in duration of exposure:
2
Justification:
Default value (ECHA)
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (ECHA)
AF for other interspecies differences:
2.5
Justification:
Default value (ECHA)
AF for intraspecies differences:
10
Justification:
Default value (ECHA)
AF for the quality of the whole database:
1
Justification:
Default value (ECHA) - study comparable to guideline study
AF for remaining uncertainties:
1
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