Registration Dossier
Registration Dossier
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EC number: 223-054-9 | CAS number: 3710-30-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.5 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):
- 62.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
For the derivation of all DNELs a NOAEL of 300 mg/kg bw/day obtained in the oral gavage 90d-repeated dose toxicity study in rats (0, 100, 300 and 1000 mg/kg bw) was chosen as dose descriptor starting point.
For workers:
Corrected inhalatory NOAEC = oralNOAEL x 1/sRVanimal x ABS oral / ABS inhalation
The standard respiratory volume (sRV) for the 8 h exposure is 0.38 m³/kg bw for rats and 6.7 m³ (per person) in humans. The default 8-h respiratory volume of a worker is 10 m³ taking increased activity into account. The inhalatory absorption is regarded to be equivalent to the oral absorption.
This results in the following equation:
Corrected inhalatory NOAEC = 300 mg/kg bw/d x 1/0.38 m³/kg bw x 6.7 m³ / 10 m3 = 529 mg/m³- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is derived from a subchronic repeated dose toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 2.5
- Justification:
- An additional assessment factor for remaining uncertainties is applied.
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:
- 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:
- 1.2 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):
- 250
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The descriptor starting point is a NOAEL. The dose response relationship is considered unremarkable.
- AF for differences in duration of exposure:
- 2
- Justification:
- The DNEL is derived from a subchronic repeated dose toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric scaling factor for differences between rats and humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- There is no evidence for species differences in the general mode of action or kinetics. However, standard AF is applied.
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for the worker.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole database is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 2.5
- Justification:
- An additional assessment factor for remaining uncertainties is applied.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
1,7-octadiene is only handled in industrial or professional settings (for details refer to IUCLID section 3.5 or to CSR section 2). Since exposure of the general public is precluded, DNELs for the general population are not relevant and thus not derived.
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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