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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.53 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):
75
Dose descriptor starting point:
NOAEL
Value:
45 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
39.67 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEL of 45 mg/kg bwday available from a repeat dose toxicity study via the oral route (OECD 422)

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
Default value for subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Accounted for in correction of starting dose
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences
AF for intraspecies differences:
5
Justification:
Default value for a worker
AF for the quality of the whole database:
1
Justification:
Available study assigned a Klimisch 1
AF for remaining uncertainties:
1
Justification:
None
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.15 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):
300
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
Value:
45 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL of 45 mg/kg bwday available from a repeat dose toxicity study via the oral route

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
Default value for subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rat
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences
AF for intraspecies differences:
5
Justification:
Default value for a worker
AF for the quality of the whole database:
1
Justification:
Available study assigned a Klimisch 1
AF for remaining uncertainties:
1
Justification:
None
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance is classified as a skin sensitiser, a category 4 acute, oral toxicant and a STOT repeat exposure category 2. The DNELs that have been derived are for long-term systemic effects for dermal and inhalation routes. It has not been possible to derive DNELs for local effects due to a lack of data or inadequate dose-response data in available studies.

The results used to derive the DNELs was the NOAEL result of 45 mg/kg bw/day for systemic toxicity, obtained from the OECD 422 combined repeated dose toxicity study with the reproductive/ developmental toxicity screening in the rat via the oral route. The corrected dose descriptors were calculated in accordance with REACH guidance on information requirements and chemical safety assessment, Chapter R.8: characterisation of dose [concentration]-response for human health. Modification of the oral result into an inhalation and dermal starting point was performed.

For inhalation exposure, the worst case assumption for absorption was used, i.e. the absorption percentage for the oral route is half that for the inhalation route. Therefore, 50 % absorption was assumed for oral absorption and 100 % absorption assumed for inhalation. This leads to the most conservation corrected dose descriptor.

For dermal exposure, it was assumed that dermal absorption would not be greater than oral absorption. Therefore, 50 % absorption was assumed for oral absorption and 50 % absorption assumed for dermal.

Default values were used for the remaining parameters.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.13 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):
150
Dose descriptor starting point:
NOAEL
Value:
45 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
19.57 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEL of 45 mg/kg bw/day available from a repeat dose toxicity study via the oral route

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
Default value for subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Accounted for in correction of starting dose
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Available study assigned a Klimisch 1
AF for remaining uncertainties:
1
Justification:
None
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.08 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):
600
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
Value:
45 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL of 45 mg/kg bw/day available from a repeat dose toxicity study via the oral route

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
Default value for subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rat
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Available study assigned a Klimisch 1
AF for remaining uncertainties:
1
Justification:
None
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.08 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
45 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation required

AF for dose response relationship:
1
Justification:
NOAEL value available
AF for differences in duration of exposure:
6
Justification:
Default value for subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rat
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Available study assigned a Klimisch 1
AF for remaining uncertainties:
1
Justification:
None
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.03 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10 000
Modified dose descriptor starting point:
other: LD50
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation required

Justification:
LD50 value available
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for rat
AF for other interspecies differences:
2.5
Justification:
Default value for remaining differences
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Available study assigned a Klimisch 1
AF for remaining uncertainties:
1
Justification:
None

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The substance is classified as a skin sensitiser, as acutely toxic via the oral route (category 4) and a STOT repeat exposure category 2. The DNELs that have been derived are for long-term systemic effects for dermal, inhalation and oral routes. It has not been possible to derive DNELs for local effects or the systemic effect following short-term exposure due to a lack of data or inadequate dose-response data in available studies.

The results used to derive the DNELs was the NOAEL result of 45 mg/kg bw/day for systemic toxicity, obtained from the OECD 422 combined repeated dose toxicity study with the reproductive/ developmental toxicity screening in the rat via the oral route. Where necessary, the corrected dose descriptors were calculated in accordance with REACH guidance on information requirements and chemical safety assessment, Chapter R.8: characterisation of dose [concentration]-response for human health. Modification of the oral result into an inhalation and dermal starting point was performed.

For inhalation exposure, the worst case assumption for absorption was used, i.e. the absorption percentage for the oral route is half that for the inhalation route. Therefore, 50 % absorption was assumed for oral absorption and 100 % absorption assumed for inhalation. This leads to the most conservation corrected dose descriptor.

For dermal exposure, it was assumed that dermal absorption would not be greater than oral absorption. Therefore, 50 % absorption was assumed for oral absorption and 50 % absorption assumed for dermal.

Default values were used for the remaining parameters.