Registration Dossier
Registration Dossier
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EC number: 942-590-0 | CAS number: -
Toxicological information
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:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- other: NAEC human worker
- Value:
- 52.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NAEC human worker=[(NOEL rep. oral tox / allometric scale) x standard human body weight ] / standard human worker breathing volume (8h) = [(30 mg/kg bw day /4) x 70 kg]/10 m^3=315 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- dose-response curve is consistent with toxicity behaviour
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC human worker
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- NAEC human worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100 % absorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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):
- 150
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- repeated oral study is the best way to assess the dermal route in absence of a repeated dermal study
- AF for dose response relationship:
- 1
- Justification:
- dose-response curve is consistent with toxicity behaviour
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- human worker
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 0.5
- Justification:
- assuming 50 % absorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.175 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):
- 150
- Modified dose descriptor starting point:
- other: NAEC human g.p.
- Value:
- 26.25 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NAEC human general population=[(NOEL rep. oral tox / allometric scale) x standard human body weight ] / standard human general population breathing volume (24h) = [(30 mg/kg bw day /4)70 kg]/20 m^3=157.5 mg/m^3
- AF for dose response relationship:
- 1
- Justification:
- dose-response curve is consistent with toxicity behaviour
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- NAEC general population
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- NAEC general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100 % absorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- AF for oral to dermal = 1
- AF for dose response relationship:
- 1
- Justification:
- dose-response curve is consistent with toxicity behaviour
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- human standard to human general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 0.5
- Justification:
- assuming 50 % absorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- from oral to dermal the assessment factor is 1
- AF for dose response relationship:
- 1
- Justification:
- dose-response curve is consistent with toxicity behaviour
- AF for differences in duration of exposure:
- 6
- Justification:
- sub acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- human standard to human general population
- AF for the quality of the whole database:
- 1
- Justification:
- GLP compliant with international guideline
- AF for remaining uncertainties:
- 1
- Justification:
- assuming 100 % absorption
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The read across justification with sodium salt and evaluation of impurities document is attached on section 13 of the dossier.
The main constituent -thelong chlorinated paraffinic chain with one sulphonic group- is in common, because raw materials and the production process are the same. Therefore, a read-across approach between the sodium and the ammonium salt can be considered reliable, considering also that the portion of the on ammonium ions is less, ca. 2 %. Impurities have been evaluated.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
