Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.7 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
DNEL value:
17.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalational study is available. A NOAEL of 10 mg/kg bw/d from a 90D oral toxicity study is converted to 7.9 mg/m3(10 mg/kg bw/d/0.38 m3/kg bw/d (rat inh vol for 8h) = 26.3 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 17.6 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
2
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:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Data from an acute inhalation toxicity study (OECD 436) is availabe, an LC50 > 5 mg/L was identified. Based on this result, no specific DNEL for acute toxocity is considered necessary as the long-term DNEL would sufficiently protect against high short term peak exposure as well.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 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:
no hazard identified
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:
0.1 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):
100
Modified dose descriptor starting point:
NOAEL
DNEL 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 90D oral toxicity study (OECD 408) is used where a NOAEL of 10 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:
2
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:
no DNEL required: short term exposure controlled by conditions for long-term
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 (T) and OBSH (S1) are both 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 0.7 mg/m3 was established for p-TSH based read-across from a NOAEL of 10 mg/kg bw/d from an oral OECD 408 90D study with OBSH (S1).

 

For local effects in respiratory tract from long term inhalational exposure a DNEL of 0.1 mg/m3 is applicable based on a ACGIH TLV of 0.1 mg/m3 for OBSH (S1) derived to protect against effects from hydrazine liberated from hydrolysis of OBSH (S1). Due to close structural similarity to p-TSH (T) and a slower hydrolysis of p-TSH, a long term inhalational exposure a DNEL of 0.1 mg/m3 is considered sufficient to protect against peak concentrations of hydrazine for p-TSH as well.

For systemic effects from long term dermal exposure, no dermal study is available. A DNEL of 0.1 mg/kg/d was established for p-TSH based on read-across from a NOAEL of 10 mg/kg bw/d found in an oral OECD 408 90D study with OBSH (S1) in rats.

 

Short term exposure is controlled by conditions for long-term exposure, therefore no DNEL has been established. Further, as OBSH (S1) and p-TSH (T) has been identified as skin sensitizers, 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.