Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.16 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
37.5
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.045 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Additional information - workers

Two DNEL values were derived for systemic effects after long-term exposure in workers: a dermal DNEL and an inhalation DNEL. Both values were obtained from the NOEL of the 90-day repeated toxicity study: 6.81 mg/kg bw/day. As this NOEL was observed in an oral study, a route-to-route extrapolation was needed in order to obtain the correct starting points for the derivation of the DNEL. The correct starting points were than divided by an overall assessment factor, which was a result of various consideration on uncertainties in inter-and intra-species variations, and on differences in the duration of exposure between test animals and humans. Moreover also the whole quality of the database was considered.

 

For acute dermal local effects, no DNEL could be derived, as although the letter of Access, no complete study report is available and therefore no quantitative data could be obtained. However the substance involves a moderate hazard after eye contact, but no irritating effects were observed after skin contact.

 

For acute dermal systemic effects, no data could be obtained by the acute dermal toxicity study, as despite the letter of Access, no complete report was available. Regarding the acute exposure, however, no exposure peaks are expected to occur and no DNEL derivation was deemed necessary. 

 

Local effects after repeated dermal exposure have been evaluated from a qualitative point of view, considering the irritation potential of the substance to the eyes.

 

No assessment was deemed necessary for mutagenicity and dermal sensitization, as the substance did not show any effect for these endpoints, while for carcinogenicity, the substance is not expected to have genotoxic potential and no specific effects have been observed during the 90-day toxicity study. Furthermore, no toxicity effects for the reproduction are expected to occur, as no specific findings have been find in reproductive organs during the 90-day repeated toxicity study and moreover no significant human exposure is expected.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Only a DNEL was derived for systemic effects after long-term exposure in general population: an inhalation DNEL obtained starting from the NOEL of the 90-day repeated toxicity study: 6.81 mg/kg bw/day. As this NOEL was observed in an oral study, a route-to-route extrapolation was needed in order to obtain the correct starting points for the derivation of the DNEL. The correct starting points were than divided by an overall assessment factor, which was a result of various consideration on uncertainties in inter-and intra-species variations, and on differences in the duration of exposure between test animals and humans. Moreover also the whole quality of the database was considered.

 

"A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate" is not sold directly to consumers and its formulations (50% w/w solution in propylene carbonate and UV curable products) are intended to industrial uses and no human exposure can be expected during service life of the articles, on which the UV coatings, inks or adhesives are applied.Furthermore inthe application processes, the substance remains included into the polymerized film; losses due to wear and tear, leaching to water or evaporation from the articles can be considered negligible (for further details see Exposure Section).