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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
80
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

DNELs for acute exposure (systemic effects)

TSP/DSP is not classified as hazardous for acute toxicity. According to REACH guidance Appendix R.8-8 it is therefore not necessary to derive acute DNEL values.

DNELs for acute and long-term exposure (local effects)

TSP/DSP is not classified as irritating to skin or eyes, or sensitising. It is therefore neither possible nor appropriate to derive acute or long-term DNEL values for local effects.

DNELs for long-term exposure (systemic effects)

Inhalation

No inhalation toxicity study is available for TSP/DSP. The inhalation DNEL was calculated using the 90-day toxicity study by oral (dietary) route withWingstay S (Styrenated Phenol)(Food and Drug Research Laboratories study No.81351, 1961). The experimental NOAEL in this study was 1000 ppm, corresponding to NOAEL approximately 40 mg/kg for males and 50 mg/kg for females.

Modification of starting point:

The lowest NOAEL (rat) 40 mg/kg was corrected to NOAEC (human) taking into account:
Allometric scaling (rat:human): 4
Bodyweight (human):                          70 kg
Worker respiratory volume (wRV):     10 m3

NOAEC (human): 70 mg/m3

Application of Assessment Factors (AF)

AFs were applied for uncertainties/variation:

Route-to-route extrapolation: 1 (100% absorption assumed for both routes)
Interspecies variability (remaining differences): 1 (no clear indication to apply default 2.5)
Intraspecies variability: 5 (default value for workers)
Exposure duration: 2 (default value for subchronic to chronic)
Quality of whole database: 2 (based on uncertainties of test substance purity, and age of the study)

Overall AF (including allometric scaling): 80

=> DNEL (inhalation long-term):   3.5 mg/m3

However, since the substance is a viscous liquid which is not expected to generate aerosols during process or use as an intermediate, and that the vapor pressure estimated using an EpiSuite model was 6.52 x 10E-12 mmHg (i.e., 8.7 x 10E-10 Pa) at 25°C and therefore considered negligible, the relevance of an inhalation DNEL should be considered questionable.

Dermal

No repeat-dose dermal toxicity study is available forTSP/DSP and no data are available on dermal absorption. It is therefore not possible to quantify the long-term dermal DNEL. However, absence of any evidence of toxicity in a limit dose of 5000 mg/kg in an acute dermal toxicity study indicates that no hazard would arise from brief intermittent dermal exposure from use as an intermediate.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

As the test substance is used as an intermediate, the derivation of DNELs for general population is not considered appropriate.