Registration Dossier
Registration Dossier
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EC number: 204-783-1 | CAS number: 126-33-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.16 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
- Dose descriptor starting point:
- NOAEC
- Value:
- 20 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 53.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEC (inhalation): Correction for experimental exposure duration (23 h/d to 8 h/d), Correction for dosing frequency: (7d/w to 5d/w) Correction for respiratory volume (worker): 6.7 m3/10 m3. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 20*(23 h/ 8 h)*(7/5)*(6.7 m3/10 m3) = 53.9 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (inhaled rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.9 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 20.3 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction for dosing frequency: 7 days/5 days.
There are data that show the registered substance is almost 100% absorbed following exposure via the oral route (Waidyanatha et al., 2019).
Additionally, there are data to support dermal absorption of 20% (Waidyanatha et al., 2019); please refer to IUCLID Section 7.1 and CSR Section 5.1 for details.
Therefore, the oral NOAEL can be corrected by a factor of 5 to derive a dermal NOAEL.
The corrected NOAEL for repeated dose systemic effects via the dermal route is: 2.9*(7/5)*5 = 20.3
Zhu, Z; Gao, N; Guo, J; et al. (1988) Studies on toxicokinetics of tritiated sulfolane in rat after oral administration. Huaxi yike daxue xuebao [J West China Univ Med Soc] 19:61−64. Available online at http://www.dec.state.ak.us/spar/csp/sites/north-pole-refinery/docs/sulfo-zhu-tox-transl.pdf. 664384. As cited in US EPA (2012) Provisional Peer-Reviewed Toxicity Values for Sulfolane (CASRN 126-33-0), National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to dermal human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.03 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.9 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the 90-day NOAEL (oral): Correction respiratory volume rat (24 hour) 1/1.15 m³/kg bw. Correction for oral to inhaled 1/2. Therefore the corrected long-term systemic inhalation NOAEC for man via the environment is: 2.9*(1/1.15)*(1/2) = 1.26 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (oral rat to inhaled human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.015 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.9 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was required to dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (subchronic to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (oral rat to oral human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
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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