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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
353 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:
NOAEL
Value:
2 500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
4 408 mg/m³
Explanation for the modification of the dose descriptor starting point:

Converted dose to account for rat inhalative volume for 8 hours/day and increased worker respiratory volume, and 100% absorption in rat and human.

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:
1
Justification:
Dosing in the selected study was for multiple generations, and the ultimate endpoint selected was based on fetotoxicity.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required when converting animal oral exposure to human inhalation exposure.
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:
50 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):
50
Dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modified dose descriptor not needed.  Assumed that absorption was 100% for all dose routes.

AF for dose response relationship:
1
Justification:
The substance does not have a steep dose response-curve.
AF for differences in duration of exposure:
1
Justification:
Dosing in the selected study was for multiple generations, and the ultimate endpoint selected was based on fetotoxicity.
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:
87 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):
25
Dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2 174 mg/m³
Explanation for the modification of the dose descriptor starting point:

Adjusted for rat respiratory volume and assumed 100% absorption for all dose routes in both species.

AF for dose response relationship:
1
Justification:
The substance does not have a steep dose-response curve.
AF for differences in duration of exposure:
1
Justification:
Dosing in the selected study was for multiple generations, and the ultimate endpoint selected was based on fetotoxicity.
AF for interspecies differences (allometric scaling):
1
Justification:
Not requred when extrapolating from oral studies in rats to inhalation exposure in humans.
AF for other interspecies differences:
2.5
Justification:
Standard adjustment factor.
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 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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25 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):
100
Dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Adjustment not required due to assumed 100% absorption from both oral and dermal dose routes.

AF for dose response relationship:
1
Justification:
Substance does not have a steep dose-response curve.
AF for differences in duration of exposure:
1
Justification:
Dosing in the selected study was for multiple generations, and the ultimate endpoint selected was based on fetotoxicity.
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 findingsngs.
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:
25 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):
100
Dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification needed due to same dose route and assumed 100% absorption in both species.

AF for dose response relationship:
1
Justification:
The substance has low oral toxicity and does not have a steep dose-response curve.
AF for differences in duration of exposure:
1
Justification:
Dosing in the selected study was for multiple generations, and the ultimate endpoint selected was based on fetotoxicity.
AF for interspecies differences (allometric scaling):
4
Justification:
Standard assessment 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 findings
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