Registration Dossier

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 neglible. 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.