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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
29.39 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):
30
Modified dose descriptor starting point:
NOAEC
Value:
881.58 mg/m³
Explanation for the modification of the dose descriptor starting point:
No dose descriptor for the inhalation route is available; therefore route to route extrapolation is used to convert the oral NOAEL. Detailed information is given in the discussion.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation is a NOAEL, therefore the default assessment factor of 1 for a standard procedure is considered appropriate.
AF for differences in duration of exposure:
6
Justification:
It is expected that the severity of effects could increase with duration. Since the dose descriptor is derived from a 28-day study, it is necessary to apply a factor of 6 to take account of extrapolation of sub-acute data from the 28-day study to chronic exposure.
AF for interspecies differences (allometric scaling):
1
Justification:
It is not necessary to apply an allometric scaling factor because the starting point has been corrected for differences in respiratory volume and this takes account of differences in metabolic rates.
AF for other interspecies differences:
1
Justification:
No differences in the metabolic pathways between humans and rats are expected, thus a factor of 1 is used for remaining interspecies differences.
AF for intraspecies differences:
5
Justification:
The default factor of 5 for workers was used to take account of intraspecies variability.
AF for the quality of the whole database:
1
Justification:
The key studies were conducted according to modern regulatory standards and were adequately reported.
AF for remaining uncertainties:
1
Justification:
No additional AF was deemed necessary.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.33 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dose descriptor for the dermal route is available; therefore route to route extrapolation is used to convert the oral NOAEL. Detailed information is given in the discussion.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation is a NOAEL, therefore the default assessment factor of 1 for a standard procedure is considered appropriate.
AF for differences in duration of exposure:
6
Justification:
It is expected that the severity of effects could increase with duration. Since the dose descriptor is derived from a sub-acute 28-day study, a factor of 6 for extrapolation from sub-acute to sub-chronic was applied according to TGD R8.
AF for interspecies differences (allometric scaling):
4
Justification:
The starting point is an oral dose descriptor from a rat study. It is therefore necessary to include an allometric scaling factor of 4 to take account of differences in basal metabolic rates between rats and humans.
AF for other interspecies differences:
1
Justification:
No differences in the metabolic pathways between humans and rats are expected, thus a factor of 1 is used for remaining interspecies differences.
AF for intraspecies differences:
5
Justification:
The default factor of 5 for workers was used to take account of intraspecies variability.
AF for the quality of the whole database:
1
Justification:
The key studies were conducted according to modern regulatory standards and were adequately reported.
AF for remaining uncertainties:
1
Justification:
No additional AF was deemed necessary.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General considerations:

 

Data on repeated dose toxicity are available for ZINN(II)-RICINOLEAT from an oral sub-acute toxicity study in rats. The relevant dose descriptor used as starting point for DNEL derivation is the NOAEL of 1000 mg/kg bw/day.

 

ZINN(II)-RICINOLEAT is a dermal sensitizer, therefore information on potency has to be provided and the respective hazard category has to be allocated. The potency was determined by the percentage of positive animals in relation to the induction concentration tested.

Based on a sensitization rate of 100 % and a intradermal induction dose of 1 % in the Guinea pig maximisation study according to OECD guideline 406 (Magnusson and Kligman) ZINN(II)-RICINOLEAT has to be regarded as strong skin sensitizer (sub-category 1A) according to guidance R8.10. Consequential the high hazard category has to be allocated and thus exposure to such a potent skin sensitising substances should be strictly contained and dermal contact avoided.

Potency information will be used in qualitative risk characterisation, a reliable dose descriptor could not be derived from the available Guinea pig maximisation test.

DNELlong –term systemic inhalation

Route to route extrapolation oral to inhalation:

 

For the derivation of a NOAEC for the worker the following corrections have to be applied to the oral NOAEL (rat).

For converting the oral NOAEL (rat) to an inhalation NOAEC for worker the oral NOAEL (rat) is multiplied with 1/0.38 m³/kg bw/8h (default respiratory volume in rat, Table R.8.2 of CSR guidance) to give the corresponding rat inhalation 8h-NOAEC (no-observed adverse effect concentration).

 

Due to the absence of route specific information a default factor of 2 is included by assuming 50 % for oral absorption (ABS oral-rat) and 100 % absorption after inhalation (ABS inh-human).

To obtain the starting point for workers, a factor of 0.67 is applied to account for the differences in inhalation rates between animals at rest and humans involved in light activity.

 

For workers the corrected inhalation NOAEC is calculated according to the following equation:

 

Corrected inhalation NOAEC:

                      = oral NOAEL x 1/sRV ratx ABS oral-rat/ ABS inh-human x sRV human/ wRV1

 

                      = 1000 x 1/0.38 x50/100 x 6.7/10

The corrected inhalation NOAEC worker(8h) is therefore:881.58 mg/m³(8h-TWA)

 

 

DNELlong–term systemic dermal

Route to route extrapolation oral to dermal:

 

The dermal NOAEL is determined to be equal to the oral NOAEL. Considering the molecular weight of 714 g/mol and a log P value of 4.8, dermal absorption is assumed to be low. Thus no additional assessment factor deemed necessary for oral-to-dermal extrapolation.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.25 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):
60
Modified dose descriptor starting point:
NOAEC
Value:
434.78 mg/m³
Explanation for the modification of the dose descriptor starting point:
No dose descriptor for the inhalation route is available; therefore route to route extrapolation is used to convert the oral NOAEL. Detailed information is given in the discussion.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation is a NOAEL, therefore the default assessment factor of 1 for a standard procedure is considered appropriate.
AF for differences in duration of exposure:
6
Justification:
It is expected that the severity of effects could increase with duration. Since the dose descriptor is derived from a sub-acute 28-day study, a factor of 6 for extrapolation from sub-acute to sub-chronic was applied according to TGD R8.
AF for interspecies differences (allometric scaling):
1
Justification:
It is not necessary to apply an allometric scaling factor because the starting point has been corrected for differences in respiratory volume and this takes account of differences in metabolic rates.
AF for other interspecies differences:
1
Justification:
No differences in the metabolic pathways between humans and rats are expected, thus a factor of 1 is used for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
The default factor of 10 for general population was used to take account of intraspecies variability.
AF for the quality of the whole database:
1
Justification:
The key studies were conducted according to modern regulatory standards and were adequately reported.
AF for remaining uncertainties:
1
Justification:
No additional AF was deemed necessary.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.17 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):
240
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dose descriptor for the dermal route is available; therefore route to route extrapolation is used to convert the oral NOAEL. Detailed information is given in the discussion.
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation is a NOAEL, therefore the default assessment factor of 1 for a standard procedure is considered appropriate.
AF for differences in duration of exposure:
6
Justification:
It is expected that the severity of effects could increase with duration. Since the dose descriptor is derived from a sub-acute 28-day study, a factor of 6 for extrapolation from sub-acute to sub-chronic was applied according to TGD R8.
AF for interspecies differences (allometric scaling):
4
Justification:
The starting point is an oral dose descriptor from a rat study. It is therefore necessary to include an allometric scaling factor of 4 to take account of differences in basal metabolic rates between rats and humans.
AF for other interspecies differences:
1
Justification:
No differences in the metabolic pathways between humans and rats are expected, thus a factor of 1 is used for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
The default factor of 10 for general population was used to take account of intraspecies variability.
AF for the quality of the whole database:
1
Justification:
The key studies were conducted according to modern regulatory standards and were adequately reported.
AF for remaining uncertainties:
1
Justification:
No additional AF was deemed necessary.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.17 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):
240
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applicable
AF for dose response relationship:
1
Justification:
The starting point for the DNEL calculation is a NOAEL, therefore the default assessment factor of 1 for a standard procedure is considered appropriate.
AF for differences in duration of exposure:
6
Justification:
It is expected that the severity of effects could increase with duration. Since the dose descriptor is derived from a sub-acute 28-day study, a factor of 6 for extrapolation from sub-acute to sub-chronic was applied according to TGD R8.
AF for interspecies differences (allometric scaling):
4
Justification:
The starting point is an oral dose descriptor from a rat study. It is therefore necessary to include an allometric scaling factor of 4 to take account of differences in basal metabolic rates between rats and humans.
AF for other interspecies differences:
1
Justification:
No differences in the metabolic pathways between humans and rats are expected, thus a factor of 1 is used for remaining interspecies differences.
AF for intraspecies differences:
10
Justification:
The default factor of 10 for general population was used to take account of intraspecies variability.
AF for the quality of the whole database:
1
Justification:
The key studies were conducted according to modern regulatory standards and were adequately reported.
AF for remaining uncertainties:
1
Justification:
No additional AF was deemed necessary.
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 considerations:

Data on repeated dose toxicity are available for ZINN(II)-RICINOLEAT from an oral sub-acute toxicity study in rats. The relevant dose descriptor used as starting point for DNEL derivation is the NOAEL of 1000 mg/kg bw/day.

 

ZINN(II)-RICINOLEAT is a dermal sensitizer, therefore information on potency has to be provided and the respective hazard category has to be allocated. The potency was determined by the percentage of positive animals in relation to the induction concentration tested.

Based on a sensitization rate of 100 % and a intradermal induction dose of 1 % in the Guinea pig maximisation study according to OECD guideline 406 (Magnusson and Kligman) ZINN(II)-RICINOLEAT has to be regarded as strong skin sensitizer (sub-category 1A) according to guidance R8.10. Consequential the high hazard category has to be allocated.

Potency information will be used in qualitative risk characterisation, a reliable dose descriptor could not be derived from the available Guinea pig maximisation test.

 

DNELlong –term systemic inhalation

Route to route extrapolation oral to inhalation:

To assess consumer inhalation exposure, the oral NOAEL (rat) is multiplied with 1/1.15 m³/kg bw (Table R.8.2 of CSR guidance) to give the corresponding 24h-NOAEC (no-observed adverse effect concentration).

 

Due to the absence of route specific information a default factor of 2 is included by assuming 50 % for oral absorption (ABS oral-rat) and 100 % absorption after inhalation (ABS inh-human).

 

For consumers the corrected inhalation NOAEC is calculated according to the following equation:

 

Corrected inhalation NOAEC:

= oral NOAEL x 1/sRV rat x ABS oral-rat/ ABS inh-rat x ABS oral-human/ ABS inh-human

= 1000 x 1/1.15 x50/100

 

The corrected inhalation NOAEC consumer (24h) is therefore:434.78 mg/m³(24-h)

 

DNELlong–term systemic dermal

Route to route extrapolation oral to dermal:

 

The dermal NOAEL is determined to be equal to the oral NOAEL. Considering the molecular weight of 714 g/mol and a log P value of 4.8, dermal absorption is assumed to be low. Thus no additional assessment factor deemed necessary for oral-to-dermal extrapolation.