Registration Dossier
Registration Dossier
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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 483-270-6 | CAS number: 54068-28-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
- Value:
- 84 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: MAK Value
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 84 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- MAK Value
- AF for dose response relationship:
- 1
- Justification:
- MAK Value
- AF for differences in duration of exposure:
- 1
- Justification:
- MAK Value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- MAK Value
- AF for other interspecies differences:
- 1
- Justification:
- MAK Value
- AF for intraspecies differences:
- 1
- Justification:
- MAK Value
- AF for the quality of the whole database:
- 1
- Justification:
- MAK Value
- AF for remaining uncertainties:
- 1
- Justification:
- MAK Value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 84 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: MAK value
- Overall assessment factor (AF):
- 1
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 84 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- MAK Value
- AF for dose response relationship:
- 1
- Justification:
- MAK Value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- MAK Value
- AF for other interspecies differences:
- 1
- Justification:
- MAK Value
- AF for intraspecies differences:
- 1
- Justification:
- MAK Value
- AF for the quality of the whole database:
- 1
- Justification:
- MAK Value
- AF for remaining uncertainties:
- 1
- Justification:
- MAK Value
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
- Value:
- 0.091 mg/m³
- Most sensitive endpoint:
- immunotoxicity
DNEL related information
- DNEL derivation method:
- other: MAK Value
- Overall assessment factor (AF):
- 1
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- MAK Value
- AF for differences in duration of exposure:
- 1
- Justification:
- MAK Value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- MAK Value
- AF for other interspecies differences:
- 1
- Justification:
- MAK Value
- AF for intraspecies differences:
- 1
- Justification:
- MAK Value
- AF for the quality of the whole database:
- 1
- Justification:
- MAK Value
- AF for remaining uncertainties:
- 1
- Justification:
- MAK Value
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
- Value:
- 0.091 mg/m³
DNEL related information
- DNEL derivation method:
- other: MAK Value
- Overall assessment factor (AF):
- 1
- Dose descriptor starting point:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- MAK Value
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- MAK Value
- AF for other interspecies differences:
- 1
- Justification:
- MAK Value
- AF for intraspecies differences:
- 1
- Justification:
- MAK Value
- AF for the quality of the whole database:
- 1
- Justification:
- MAK Value
- AF for remaining uncertainties:
- 1
- Justification:
- MAK Value
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 mg/kg bw/day
- Most sensitive endpoint:
- immunotoxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3 000
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- [oral absorption rat 50 %/dermal absorption human 1 %]
- AF for dose response relationship:
- 10
- Justification:
- LOAL - > NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value in line with Table R.8-3 and Appendix R. 8-2, part 2, example B5 of Chapter R.8 of Guidance on information requirements and chemical safety assessmen
- AF for other interspecies differences:
- 1
- Justification:
- not relevant
- AF for intraspecies differences:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Good quality data available
- AF for remaining uncertainties:
- 2.5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
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:
- 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
DNEL related information
- Overall assessment factor (AF):
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Overall assessment factor (AF):
- 5
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
DNEL related information
- Overall assessment factor (AF):
- 5
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
The substance is used a an intermediate for polymerisation in industry.In the polymerisation process the substance reacts completly and becomes an inseperable part of the matrix. Migration studies have shown that there is not release of Dioctyltin form the matrix. Also in solution experiments with the matrix (tetrahydrofurane, hexane, ...) could not any longer determine Dioctyltin anymore.
In conclusion there is no hazard vor the general population / consumer.
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