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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
23.5 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):
75
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:

The rat 4-week oral NOAEL of 1000 mg/kg bw/day was used as the starting point.

Modification of dose descriptor

The equivalent rat inhalation NOAEC was derived using route-to-route extrapolation, based on assumption of 100% absorption after ingestion and inhalation.

The inhalatory NOAEC may be calculated as follows:

NOAECinhalation = NOAELoral x 1/sRVrat x ABSoral-rat/ABSinh-human x sRVhuman/wRVhuman

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

= 1763 mg/m3 (4 -week duration of exposure)

AF for dose response relationship:
1
Justification:
Default AF
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic extrapolation
Justification:
AF not required
AF for other interspecies differences:
2.5
Justification:
For remaining differences
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
Default AF
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:
3.33 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):
300
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The rat 4 -week oral NOAEL of 1000 mg/kg bw/day was used as the starting point.

Modification of dose descriptor

The equivalent dermal NOAEL was derived using route-to-route extrapolation, based on assumption of 100% absorption after ingestion and 100% after skin contact.

The dermal NOAEL may be calculated as follows:

NOAELdermal = NOAELoral x ABSoral-rat/ABSdermal-human

= 1000 x 100/100

= 1000 mg/kg bwt/day (4 -week duration of exposure)

AF for dose response relationship:
1
Justification:
Default AF
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF for remaining differences
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
Default AF
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:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Acute Toxicity

A DNEL for acute toxicity need only be derived if an acute hazard leading to acute toxicity (e.g. classified under CLP) has been identified and there is a potential for high peak exposures. If no hazard has been identified, then a DNEL for acute toxicity is unnecessary as the long-term DNEL will be sufficient to ensure that adverse effects do not occur. Di-tert-nonyl polysulfides is neither acutely toxic nor is it an irritant (eye, skin or respiratory tract) and therefore no acute DNELs (systemic or local) have been calculated.

Di-tert-nonyl polysulfides is classified as sensitising to skin, Category 1B, therefore the substance is assessed qualitatively for dermal local acute hazard.

Long-term Systemic Toxicity

The available data indicate a NOAEL of 1000 mg/kg bw/day for di-tert-nonyl polysulfides, based on a 4-week oral toxicity study (Elf Aquitaine Production, 1995) in rats administered di-tert-dodecyl polysulfide (TPS 32), a structural analogue of di-tert-nonyl polysulfides.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.8 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):
150
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
870 mg/m³
Explanation for the modification of the dose descriptor starting point:

Dose descriptor

The rat 4 -week oral NOAEL of 1000 mg/kg bw/day was used as the starting point.

Modification of dose descriptor

The equivalent rat inhalation NOAEC was derived using route-to-route extrapolation, based on 100% absorption after ingestion and inhalation.

The inhalatory NOAEC may be calculated as follows:

NOAECinhalation = NOAELoral x 1/sRVrat x ABSoral-rat/ABSinh-human

= 1000 x 1/1.15 x 100/100

= 870 mg/m3 (4-week duration of exposure)

AF for dose response relationship:
1
Justification:
default AF
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic extrapolation
Justification:
AF not required.
AF for other interspecies differences:
2.5
Justification:
default for remaining differences
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
default AF
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:
1.66 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor

The rat 4 -week oral NOAEL of 1000 mg/kg bw/day was used as the starting point.

Modification of dose descriptor

The equivalent dermal NOAEL was derived using route-to-route extrapolation, based on assumption of 100% absorption after ingestion and 100% after skin contact.

The dermal NOAEL may be calculated as follows:

NOAELdermal = NOAELoral x ABSoral-rat/ABSdermal-human

= 1000 x 100/100

= 1000 mg/kg bwt/day (4 -week duration of exposure)

AF for dose response relationship:
1
Justification:
default AF
AF for differences in duration of exposure:
6
Justification:
subacute to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
default AF
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:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.66 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):
600
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dose descriptor

The rat 4 -week oral NOAEL of 1000 mg/kg bw/day was used as the starting point.

Modification of dose descriptor

The equivalent dermal NOAEL was derived using route-to-route extrapolation, based on assumption of 100% absorption after ingestion by both humans and rats.

The oral NOAEL may be calculated as follows:

NOAELoral = NOAELoral x ABSoral-rat/ABSoral-human

= 1000 x 100/100

= 1000 mg/kg bwt/day (4 -week duration of exposure)

AF for dose response relationship:
1
Justification:
default AF
AF for differences in duration of exposure:
6
Justification:
sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat
AF for other interspecies differences:
2.5
Justification:
default for remaining differences
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
1
Justification:
default AF
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

Acute Toxicity

A DNEL for acute toxicity need only be derived if an acute hazard leading to acute toxicity (e. g. classified under CLP) has been identified and there is a potential for high peak exposures. If no hazard has been identified, then a DNEL for acute toxicity is unnecessary as the long-term DNEL will be sufficient to ensure that adverse effects do no occur. Di-tert-nonyl polysulfides is neither acutely toxic nor is it an irritant (eye, skin or respiratory tract) and therefore no acute DNELs (systemic or local) have been calculated.

Di-tert-nonyl polysulfides is classified as sensitising to skin, Category 1B, therefore the substance is assessed qualitatively for dermal local acute hazard.

Long-term Systemic Toxicity

The available data indicate a NOAEL of 1000 mg/kg bw/day for di-tert-nonyl polysulfides, based on a 4 -week oral toxicity study (Elf Aquitaine Production, 1995) in rats administered di-tert-dodecyl polysulfide (TPS 32), a structural analogue of di-tert-nonyl polysulfides.