Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
42.32 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
528.95 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalatory NOAEC=oral NOAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.) = 300 * (1/0.38)*0.67*1 = 528.95 mg/m3 

 

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is a NOAEL therefore the AF for dose response relationship is 1
AF for differences in duration of exposure:
1
Justification:
The dose descriptor was obtained from a teratogenicity study in the rat with experimental exposure which adequately covered the pregnancy of this species, therefore the AF for differences in duration of exposure is 1
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling AF is not used for the calculation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
There are no data for softanol to quantify other differences between animals and humans that could affect interspecies extrapolation. On this basis a default factor of 2.5 to account for other species differences will also be applied.
AF for intraspecies differences:
5
Justification:
There are no data to quantify variability in susceptibility to the effects of long-term exposure to softanol in the human population. The default factor of 5 for workers will therefore be used to take account of intraspecies differences.
AF for the quality of the whole database:
1
Justification:
There is no datagap and the animal studies are of high quality therefore the AF for the quality of the whole database is 1
AF for remaining uncertainties:
1
Justification:
There is no 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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral to Dermal NOAEL=oral NOAEL*( ABSoral/ABSdermal)= 300mg/kg/d

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is a NOAEL therefore the AF for dose response relationship is 1
AF for differences in duration of exposure:
1
Justification:
The dose descriptor was obtained from a teratogenicity study in the rat with experimental exposure which adequately covered the pregnancy of this species, therefore the AF for differences in duration of exposure is 1
AF for interspecies differences (allometric scaling):
4
Justification:
The dose descriptor is obtained from a teratogenicity study in the rat. It is therefore necessary to apply an allometric scaling factor of 4 to take account of differences in basal metabolic rates between rats and humans.
AF for other interspecies differences:
2.5
Justification:
There are no data for softanol to quantify other differences between animals and humans that could affect interspecies extrapolation. On this basis a default factor of 2.5 to account for other species differences will also be applied.
AF for intraspecies differences:
5
Justification:
There are no data to quantify variability in susceptibility to the effects of long-term exposure to softanol in the human population. The default factor of 5 for workers will therefore be used to take account of intraspecies differences.
AF for the quality of the whole database:
1
Justification:
There is no datagap and the animal studies are of high quality therefore the AF for the quality of the whole database is 1
AF for remaining uncertainties:
1
Justification:
There is no 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
Most sensitive endpoint:
sensitisation (skin)

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:
21.16 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
130.43 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral to Inhalation NOAEC= oral NOAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh.)=300 * (1/1.15) * (0.5/1) = 130.43 mg/m3

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is a NOAEL therefore the AF for dose response relationship is 1
AF for differences in duration of exposure:
1
Justification:
The dose descriptor was obtained from a teratogenicity study in the rat with experimental exposure which adequately covered the pregnancy of this species, therefore the AF for differences in duration of exposure is 1
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling AF is not used for the calculation of inhalation DNEL
AF for other interspecies differences:
2.5
Justification:
There are no data for softanol to quantify other differences between animals and humans that could affect interspecies extrapolation. On this basis a default factor of 2.5 to account for other species differences will also be applied.
AF for intraspecies differences:
10
Justification:
There are no data to quantify variability in susceptibility to the effects of long-term exposure to softanol in the human population. The default factor of 10 for the general population will therefore be used to take account of intraspecies differences.
AF for the quality of the whole database:
1
Justification:
There is no datagap and the animal studies are of high quality therefore the AF for the quality of the whole database is 1
AF for remaining uncertainties:
1
Justification:
There is no 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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral to Dermal NOAEC=oral (NOAEL*( ABSoral/ABSdermal) = 300 mg/kg/d

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is a NOAEL therefore the AF for dose response relationship is 1
AF for differences in duration of exposure:
1
Justification:
The dose descriptor was obtained from a teratogenicity study in the rat with experimental exposure which adequately covered the pregnancy of this species, therefore the AF for differences in duration of exposure is 1
AF for interspecies differences (allometric scaling):
4
Justification:
The dose descriptor is obtained from a teratogenicity study in the rat. It is therefore necessary to apply an allometric scaling factor of 4 to take account of differences in basal metabolic rates between rats and humans.
AF for other interspecies differences:
2.5
Justification:
There are no data for softanol to quantify other differences between animals and humans that could affect interspecies extrapolation. On this basis a default factor of 2.5 to account for other species differences will also be applied.
AF for intraspecies differences:
10
Justification:
There are no data to quantify variability in susceptibility to the effects of long-term exposure to softanol in the human population. The default factor of 10 for the general population will therefore be used to take account of intraspecies differences
AF for the quality of the whole database:
1
Justification:
There is no datagap and the animal studies are of high quality therefore the AF for the quality of the whole database is 1
AF for remaining uncertainties:
1
Justification:
There is no 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
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral to Dermal NOAEC=oral (NOAEL*( ABSoral/ABSdermal) = 300 mg/kg/d

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is a NOAEL therefore the AF for dose response relationship is 1
AF for differences in duration of exposure:
1
Justification:
The dose descriptor was obtained from a teratogenicity study in the rat with experimental exposure which adequately covered the pregnancy of this species, therefore the AF for differences in duration of exposure is 1
AF for interspecies differences (allometric scaling):
4
Justification:
The dose descriptor is obtained from a teratogenicity study in the rat. It is therefore necessary to apply an allometric scaling factor of 4 to take account of differences in basal metabolic rates between rats and humans.
AF for other interspecies differences:
2.5
Justification:
There are no data for softanol to quantify other differences between animals and humans that could affect interspecies extrapolation. On this basis a default factor of 2.5 to account for other species differences will also be applied.
AF for intraspecies differences:
10
Justification:
There are no data to quantify variability in susceptibility to the effects of long-term exposure to softanol in the human population. The default factor of 10 for the general population will therefore be used to take account of intraspecies differences
AF for the quality of the whole database:
1
Justification:
There is no data gap and the animal studies are of high quality therefore the AF for the quality of the whole database is 1
AF for remaining uncertainties:
1
Justification:
There are no 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