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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
141 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):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/0.38) and activity (*0.67) results in a corrected starting point (inhalation NOAEC) of 1763 mg/m3. Correction for the extent of oral absorption and inhalation absorption is not required as oral absorption is likely to represent the worst case.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
1
Justification:
Not required: already accounted for
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (worker)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

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:
1.7 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):
50
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal toxicity data are available; dermal DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (rat study)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (worker)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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

Inhalation DNEL values

No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/0.38) and activity (*0.67) results in a corrected starting point (inhalation NOAEC) of 1763 mg/m3. Correction for the extent of oral absorption and inhalation absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 1 (for allometric factors), 2.5 (for other intraspecies differences), 5 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 12.5. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic inhalation DNEL of 141 mg/m3.

The substance is of very low acute toxicity. In the absence of a hazard, an acute inhalation systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local inhalation DNELs are not derived.

Dermal DNEL values

No dermal toxicity data are available; dermal DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d. Correction for the extent of oral absorption and dermal absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 4 (for allometric factors), 2.5 (for other intraspecies differences), 5 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 50. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic dermal DNEL of 20 mg/kg bw/d.

The substance is of very low acute toxicity. In the absence of a hazard, an acute dermal systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local dermal DNELs are not derived.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35 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:
870 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/1.15) results in a corrected starting point (inhalation NOAEC) of 870 mg/m3.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
1
Justification:
Not required: already accounted for
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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:
10 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal toxicity data are available; dermal DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (rat)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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:
10 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not required
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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

Inhalation DNEL values

No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/1.15) results in a corrected starting point (inhalation NOAEC) of 870 mg/m3. Correction for the extent of oral absorption and inhalation absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 1 (for allometric factors), 2.5 (for other intraspecies differences), 10 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 5. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic inhalation DNEL of 141 mg/m3.

The substance is of very low acute toxicity. In the absence of a hazard, an acute inhalation systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local inhalation DNELs are not derived.

Dermal DNEL values

 

No dermal toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d. Correction for the extent of oral absorption and dermal absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 4 (for allometric factors), 2.5 (for other intraspecies differences), 10 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 100. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic DNEL of 10 mg/kg bw/d.

The substance is of very low acute toxicity. In the absence of a hazard, an acute dermal systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local dermal DNELs are not derived.

 

Oral DNEL values

Oral DNELs are derived using the oral toxicity data as a starting point.  Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 4 (for allometric factors), 2.5 (for other intraspecies differences), 10 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 100. Application of the overall Assessment Factor to the corrected starting point results in a long-term oral systemic DNEL of 10 mg/kg bw/d.

The substance is of very low acute toxicity. In the absence of a hazard, an acute oral systemic DNEL is not derived.