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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.45 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
BMDL05
Value:
10.3 mg/kg bw/day
Modified dose descriptor starting point:
BMCL05
Value:
18.16 mg/m³
Explanation for the modification of the dose descriptor starting point:

Based on the toxicokinetic assessment, it is expected that there will be 100 % oral and inhalation absorption of the test item. In accordance with ECHA Guidance on Information Requirements & Chemical Safety Assessment Chapter R.8 the modified dose descriptor has been calculated as follows:

10.3 mg/kg bw/day × (1/0.38 m3/kg/day) × (6.7 m3/10 m3) × (100 % rat oral absorption / 100 % human inhalation absorption)

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Reproductive/developmental effects are the most sensitive endpoint, with a more conservative BMDL05 value compared to a 2-year repeat-dose study NOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied for inhalation exposure route
AF for other interspecies differences:
2.5
Justification:
Standard default value for other interspecies differences as indicated by ECHA Guidance on Information Requirements & Chemical Safety Assessment Chapter R.8
AF for intraspecies differences:
5
Justification:
Standard default value for workers as indicated by ECHA Guidance on Information Requirements & Chemical Safety Assessment Chapter R.8
AF for the quality of the whole database:
1
Justification:
Reliable study and good quality database
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:
68.7 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
30
Dose descriptor starting point:
BMDL05
Value:
10.3 mg/kg bw/day
Modified dose descriptor starting point:
BMDL05
Value:
2 060 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based on the toxicokinetic assessment, it is expected that there will be 100 % oral and 0.5 % dermal absorption of the test item. In accordance with ECHA Guidance on Information Requirements & Chemical Safety Assessment Chapter R.8 the modified dose descriptor has been calculated as follows:

10.3 mg/kg bw/day × (100 % rat oral absorption / 0.5 % human dermal absorption)

AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Reproductive/developmental effects are the most sensitive endpoint, with a more conservative BMDL05 value compared to a 2-year repeat-dose study NOAEL
AF for other interspecies differences:
5
AF for intraspecies differences:
6
AF for the quality of the whole database:
1
Justification:
Reliable study and good quality database
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:
DNEL (Derived No Effect Level)
Value:
0.73 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
25
Dose descriptor starting point:
BMDL05
Value:
10.3 mg/kg bw/day
Modified dose descriptor starting point:
BMCL05
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
Justification:
Reproductive/developmental effects are the most sensitive endpoint, with a more conservative BMDL05 value compared to a 2-year repeat-dose study NOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied for inhalation exposure route
AF for other interspecies differences:
2.5
Justification:
Standard default value for other interspecies differences as indicated by ECHA Guidance on Information Requirements & Chemical Safety Assessment Chapter R.8
AF for intraspecies differences:
10
Justification:
Standard default value for general population as indicated by ECHA Guidance on Information Requirements & Chemical Safety Assessment Chapter R.8
AF for the quality of the whole database:
1
Justification:
Reliable study and good quality database
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:
34.3 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
60
Dose descriptor starting point:
BMDL05
Value:
10.3 mg/kg bw/day
Modified dose descriptor starting point:
BMDL05
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:
DNEL (Derived No Effect Level)
Value:
0.17 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
60
Dose descriptor starting point:
BMDL05
Value:
10.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification required.

AF for other interspecies differences:
10
Justification:
Derived from authoritative evaluations
AF for intraspecies differences:
6
Justification:
Derived from authoritative evaluations
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
60
Dose descriptor starting point:
BMDL05
Value:
10.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification required.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population