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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.09 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
7.1 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalational study is available. A NOAEL of 4 mg/kg bw/d from a subacute oral toxicity study (OECD 422) is converted to 7.1 mg/m3(4 mg/kg bw/d/0.38 m3/kg bw/d (rat inh vol for 8h) = 10.5 mg/m3and then further modified with a factor 6.7 m3/10 m3due to higher respiration volume during work. The modified starting point is then 7.1 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is not to be used as the dose level has been converted to inhalational concentration
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.13 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ACGIH OEL value, read-across to hydrazine
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
0.013 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
Modified dose descriptor starting point:
NOAEL
Value:
10 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal repeated dose toxicity studies are available. Data from a subacute oral toxicity study (OECD 422) is used where a NOAEL of 4 mg/kg bw/d was identified. As no data regarding skin absorption is available similar absorption after dermal exposes as after oral exposure is assumed as a worst-case scenario.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
low hazard (no threshold derived)

Additional information - workers

p-TSH is used as blowing agents in industrial processing and for professional uses.


 


For systemic effects from long term inhalational exposure, no inhalational study is available. A DNEL of 0.09 mg/m3 was established for p-TSH based on NOAEL of 4 mg/kg bw/d from an oral OECD 422 study.


For local effects in respiratory tract from long term inhalational exposure a DNEL of 0.13 mg/m3 is applicable based on a ACGIH TLV of 0.13 mg/m3 for hydrazine to protect against effects from hydrazine liberated from hydrolysis of p-TSH. 


For systemic effects from long term dermal exposure, no dermal study is available. A DNEL of 0.013 mg/kg/d was established for p-TSH based on  a NOAEL of 4 mg/kg bw/d found in an oral OECD 422 in rats.


 


Short term exposure is controlled by conditions for long-term exposure, therefore no DNEL has been established. Further, as p-TSH has been identified as a skin sensitizer, strict control measures should apply.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

No hazard can be identified for consumers and the general population as exposure is considered negligible. p-TSH is used as a blowing agent and during the foaming process, p-TSH decomposes into nitrogen and toluene-4-sulphonic acid which is further degraded during this process. Therefore, a direct consumer exposure is not likely to occur since p-TSH is not contained in final products.