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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
5.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Value:
1 300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
383 mg/m³
Explanation for the modification of the dose descriptor starting point:

Assumed rat dermal exposure was 10.9-fold greater than in vitro human exposure. Converted dose to account for rat inhalative volume for 8 hours/day and worker respiratory volume.  Assumed 100% inhalation exposure in humans.

AF for dose response relationship:
1
Justification:
Substance has low toxicity and dose-response curve is not steep.
AF for differences in duration of exposure:
6
Justification:
Extrapolated fomr a "sub acute - 28-day" study to chronic exposure. This is a standard ECHA factor.
AF for interspecies differences (allometric scaling):
1
Justification:
Already accounted for based on respiratory volume correction factors.
AF for other interspecies differences:
2.5
Justification:
No data available to justify alterations to standard factor.
AF for intraspecies differences:
5
Justification:
Standard factor to be applied for workers.
AF for the quality of the whole database:
1
Justification:
There are sufficient studies available to indicate data from this study are representative.
AF for remaining uncertainties:
1
Justification:
No data indicating there should be additional concerns.
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:
47 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
1 300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
14 190 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modified dose descriptor not needed.  Assumed that dermal absorption was 16.7% in rats and 1.53% in human.

AF for dose response relationship:
1
Justification:
The substance does not have a steep dose response-curve.
AF for differences in duration of exposure:
6
Justification:
Extrapolated from a 28-day (sub-acute) study to chronic exposure.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor to extrapolate from rat to human.
AF for other interspecies differences:
2.5
Justification:
Standard factor to account for potential differences in pharmacokinetics.
AF for intraspecies differences:
5
Justification:
Standard factor to account for worker variability.
AF for the quality of the whole database:
1
Justification:
The database is robust given the number and type of studies available, and consistency of findings.
AF for remaining uncertainties:
1
Justification:
No additional assessment factors needed.
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:
1.26 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
1 300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
189 mg/m³
Explanation for the modification of the dose descriptor starting point:

Assumed rat dermal exposure was 10.9-fold greater than in vitro human exposure value. Converted dose to account for rat and general population respiratory volumes.  Assumed 100% inhalation exposure in humans.

AF for dose response relationship:
1
Justification:
The substance does not have a steep dose-response curve.
AF for differences in duration of exposure:
6
Justification:
Standard factor for extrapolating from 28-day sub-acute study to chronic exposure.
AF for interspecies differences (allometric scaling):
1
Justification:
Already accounted for when adjusting for rat and human respiratory volumes.
AF for other interspecies differences:
2.5
Justification:
Standard assessment factor for general population.
AF for intraspecies differences:
10
Justification:
Standard assessment factor for general population.
AF for the quality of the whole database:
1
Justification:
The database is robust given the number and type of studies available, and consistency of findings
AF for remaining uncertainties:
1
Justification:
No additional assessment factors needed.
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:
23.7 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
1 300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
14 190 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Assumed 16.7% dermal absorption in rats and 1.53% absorption in humans.

AF for dose response relationship:
1
Justification:
Substance does not have a steep dose-response curve.
AF for differences in duration of exposure:
6
Justification:
Standard factor extrapolating from 28-day study to chronic study.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard scaling factor for extrapolating from rats to humans.
AF for other interspecies differences:
2.5
Justification:
Standard factor to account for potential differences in pharmacokinetics.
AF for intraspecies differences:
10
Justification:
Standard factor for general population.
AF for the quality of the whole database:
1
Justification:
The database is robust given the number and type of studies available, and consistency of findings.
AF for remaining uncertainties:
1
Justification:
No assessment factor needed.
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:
0.362 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
1 300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
217 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Assumed 16.7% dermal absorption in rat, and 100% oral absorption in both rat and human.

AF for dose response relationship:
1
Justification:
The substance did not exhibit toxicity following dermal dosing and does not have a steep dose-response curve.
AF for differences in duration of exposure:
6
Justification:
Standard factor for extrapolating from 28-day (sub-acute) study to chronic exposure.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor to extrapolate from rat to human.
AF for other interspecies differences:
2.5
Justification:
Standard assessment factor to account for differences in pharmacokinetics.
AF for intraspecies differences:
10
Justification:
Standard assessment factor for the general population.
AF for the quality of the whole database:
1
Justification:
The database is robust given the number and type of studies available and consistency of effects.
AF for remaining uncertainties:
1
Justification:
No additional assessment factor needed.
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