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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
882 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and inhalation absorption (default assumptions), breathing rate and exposure time to give a modified (inhalation) NOAEC of 882 mg/m3.

AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
2
Justification:
Extrapolation from studies of up to sub-chronic in duration, to chronic exposure.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required: already taken into account in modification of the starting point.
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainty
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:
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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and dermal absorption (default assumptions) to give a modified (dermal) NOAEL of 1000 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
2
Justification:
Extrapolation from studies of up to sub-chronic in duration, to chronic exposure.
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: starting point derived from a rat study
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainties
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

Workers

No toxicological adverse effects of treatment were seen in a screening study, one-generation study or a prenatal developmental toxicity study at a dose level of 1000 mg/kg bw/d. The NOAEL of 1000 mg/kg bw/d is therefore used as the starting point for the derivation of long-term systemic DNEL values for workers. Short-term systemic DNELs are not derived in the absence of any identified hazard. Local DNELs are not derived in the absence of any identified hazard.

Long-term systemic inhalation DNEL

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and inhalation absorption (default assumptions), breathing rate and exposure time to give a modified (inhalation) NOAEC of 882 mg/m3. The corrected starting point is adjusted through the application of individual assessment factors of 1 (for dose-response relationship), 2 (for the duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 5 for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties). Combining the individual assessment factors results in an overall assessment factor of 25. Applying the overall assessment factor to the corrected starting point results in a DNEL of 35 mg/m3.

Long-term systemic dermal DNEL

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and dermal absorption (default assumptions) to give a modified (dermal) NOAEL of 1000 mg/kg bw/d. The corrected starting point is adjusted through the application of individual assessment factors of 1 (for dose-response relationship), 2 (for the duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 5 for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties). Combining the individual assessment factors results in an overall assessment factor of 100. Applying the overall assessment factor to the corrected starting point results in a DNEL of 10 mg/kg bw/d.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9 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):
50
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
435 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and inhalation absorption (default assumptions) and breathing rate to give a modified (inhalation) NOAEC of 435 mg/m3.

AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
2
Justification:
Default value: studies of up to sub-chonic duration extrapolated to chronic exposure.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required: already accounted for in correction of the starting point
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainty
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:
5 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and dermal absorption (default assumptions) to give a modified (dermal) NOAEL of 1000 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
2
Justification:
Extrapolation from studies of up to sub-chronic duation to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: starting point is from a rat study
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value: no significant remaining uncertainty
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:
5 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
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point of 1000 mg/kg bw/d is from an oral study and does not therefore require correction.

AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
2
Justification:
Default value: extrapolation from studies of up to sub-chronic duration to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Default value: starting point is from a rat study
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: no significant remaining uncertainties
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

General Population

No toxicological adverse effects of treatment were seen in a screening study, one-generation study or a prenatal developmental toxicity study at a dose level of 1000 mg/kg bw/d. The NOAEL of 1000 mg/kg bw/d is therefore used as the starting point for the derivation of long-term systemic DNEL values for the general population. Short-term systemic DNELs are not derived in the absence of any identified hazard. Local DNELs are not derived in the absence of any identified hazard.

Long-term systemic inhalation DNEL

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and inhalation absorption (default assumptions) and breathing rate to give a modified (inhalation) NOAEC of 435 mg/m3. The corrected starting point is adjusted through the application of individual assessment factors of 1 (for dose-response relationship), 2 (for the duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 10 for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties). Combining the individual assessment factors results in an overall assessment factor of 50. Applying the overall assessment factor to the corrected starting point results in a DNEL of 9 mg/m3.

Long-term systemic dermal DNEL

The starting point of 1000 mg/kg bw/d is corrected for the relative extent of oral and dermal absorption (default assumptions) to give a modified (dermal) NOAEL of 1000 mg/kg bw/d. The corrected starting point is adjusted through the application of individual assessment factors of 1 (for dose-response relationship), 2 (for the duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties). Combining the individual assessment factors results in an overall assessment factor of 200. Applying the overall assessment factor to the corrected starting point results in a DNEL of 5 mg/kg bw/d.

Long-term systemic oral DNEL

The starting point of 1000 mg/kg bw/d is from an oral study and does not therefore require correction. The starting point is adjusted through the application of individual assessment factors of 1 (for dose-response relationship), 2 (for the duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties). Combining the individual assessment factors results in an overall assessment factor of 200. Applying the overall assessment factor to the corrected starting point results in a DNEL of 5 mg/kg bw/d.