Registration Dossier
Registration Dossier
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EC number: 201-286-1 | CAS number: 80-51-3
Toxicological Summary
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
- 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:
- iallometric scaling s 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
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
- 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
OBSH is used as a blowing agent 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 based on a NOAEL of 10 mg/kg bw/d from an oral OECD 408 90D study.
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 derived to protect against effects from hydrazine liberated from hydrolysis of OBSH.
For systemic effects from long term dermal exposure, no dermal study is available. A DNEL of 0.1 mg/kg/d was established based on a NOAEL of 10 mg/kg bw/d from an oral OECD 408 90D study with rats.
Short term exposure is controlled by conditions for long-term exposure, therefore no DNEL has been established. Further, as OBSH 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 identification relevant for consumers and the general population as exposure to OBSH is considered negligible. OBSH is used as a blowing agent and during the foaming process, OBSH during this process decomposes into nitrogen and 4,4-oxybis (benzenesulfonic acid) which is further transformed into polydithiophenyl ether and polymetric thiosulfonate. Therefore, a direct consumer exposure is not likely to occur since OBSH is not contained in final products.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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