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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
212.42 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
NOAEC
Value:
5 284 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
2 500 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point NOAEC (neonatal toxicity) obtained according to OECD 414 was modified accounting for the differences between experimental and human exposure conditions. The conversion of a rat inhalation NOAEC to a corrected inhalaton NOAEC to assess human inhalation exposure was performed: to take into account the differences in exposure duration a factor of 0.75 was included (6 h for the rodent to 8 h for the worker), additionally a factor of 0.67 is included (6.7m³, as a respiratory volume for humans for an 8-hour shift divided by 10 m³, the respiratory volume for worker by light activity). Corrected NOAEC = 5284 mg/m³ * 0.75* 0.67 = 2655.2 mg/m³

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
No correction is used as the endpoint was from a prenatal developmental toxicity study. As there is no variation possible for the duration of exposure (as gestation is a fixed duration), there is not correction value. That is, rat gestation is 19 day. It can't be longer, so there's no chronic expsoure possible to correct for.
AF for interspecies differences (allometric scaling):
1
Justification:
There is no allometric scaling in inhalation studies
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
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 062.1 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

The standard value of 5x the long term DNEL was used to establish the short-term DNEL.

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:
20.18 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
Value:
5 284.05 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
1 008.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point for a long-term systemic DNEL (dermal) value for workers was the NOAEC value of 5284.05 mg/m³ from the pre-natal developmental toxicity study in rats via inhalation. The starting point NOAEC obtained in the animal study was corrected accounting for the differences between experimental and human exposure conditions. The conversion of an inhalation rat NOAEC into a corrected dermal NOAEL to assess human dermal exposure was performed: to take into account the differences in respiratory volume of rats versus humans a factor of 0.38 was included; to take into account the differences in exposure duration a factor of 0.75 was included (6 h for the rodent to 8 h for the worker). A correction of 0.67 for light work was also included. Applying those factors resulted in a corrected value of 1008.9 mg/kg

AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Duration of exposure is not valid in a developmental toxicity study as dosing only runs as long as gestation, and that time period can't be prolonged. So there is no acute or chronic dosing to adjust for.
AF for interspecies differences (allometric scaling):
4
Justification:
default value
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
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
52.84 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
5 284 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 321.01 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point NOAEC (neonatal toxicity) obtained according to OECD 414 was modified accounting for the differences between experimental and human exposure conditions. The conversion of a rat inhalation NOAEC to a corrected inhalaton NOAEC to assess human inhalation exposure was performed: to take into account the differences in exposure duration a factor of 0.25 was included (6 h for the rodent to 24 h for the general population ), No correction for light work is added for general population and the study was conducted for 7 days a week, so there is no time correction. Corrected NOAEC = 5284 mg/m³ * 0.25 = 1321 mg/m³

AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
As this is a developmental study, there is a fixed period of gestation and as such, there can't be an "acute" or "chronic" time period to adjust for, so there is no correction for dosing time.
AF for interspecies differences (allometric scaling):
1
Justification:
No scaling for inhalation studies
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default values
AF for the quality of the whole database:
1
Justification:
Default values
AF for remaining uncertainties:
1
Justification:
Default values
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
264.2 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

The standard adjustment of 5x the long term DNEL is used to establish the short term DNEL

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:
15.19 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
5 284.05 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
1 519 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point NOAEC (neonatal toxicity) obtained according to OECD 414 was modified accounting for the

differences between experimental and human exposure conditions. The conversion of a rat inhalation NOAEC to a corrected inhalaton NOAEC to assess human inhalation exposure was performed: to take into account the differences in exposure duration a factor of 0.25 was included (6 h for the rodent to 24 h for the general population ).  The inhalation to dermal route was corrected for by multiplying 5284.05 mg/m3 by 1.15 m3/kg/24hours to give 1519 mg/kg/day

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
No adjustment is used as the study was a developmental toxicity study, and since gestation is a fixed time point, there is no "long term" or chronic version of the study to adjust for.
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
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
15.19 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
5 284.05 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 519 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point NOAEC (neonatal toxicity) obtained according to OECD 414 was modified accounting for the

differences between experimental and human exposure conditions. The conversion of a rat inhalation NOAEC to a corrected inhalaton NOAEC to assess human inhalation exposure was performed: to take into account the differences in exposure duration a factor of 0.25 was included (6 h for the rodent to 24 h for the general population ).  The inhalation to dermal route was corrected for by multiplying 5284.05 mg/m3 by 1.15 m3/kg/24hours to give 1519 mg/kg/day

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
1
Justification:
No adjustment is used as the study was a developmental toxicity study, and since gestation is a fixed time point, there is no "long term" or chronic version of the study to adjust for.
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
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population