Registration Dossier
Registration Dossier
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EC number: 421-720-5 | CAS number: 18085-02-4 3,4-DIACETOXY-1-BUTENE
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.97 mg/m³
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 148 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Extrapolation from oral toxicity data to inhalation route.
DNEL = 120 mg/kg/bw * ((6.7/10) * (0.5) * (7/5) * (1/0.38)) = (148 mg/m3/ 75) = 1.97 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA R.8 guidance (route to route ABS included in dose descriptor)
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA R.8 guidance (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA R.8 guidance (allometric scaling not required)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R.8 guidance (interspecies rat to human)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA R.8 guidance (intraspecies worker)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable OECD 421 study available.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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:
- 0.56 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 168 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Modification factor of 1.4 used to account for 7 days/week exposure in study to 5 days/week for worker conditions.
- AF for dose response relationship:
- 1
- Justification:
- ECHA R.8 guidance (starting point a NOAEL; oral to dermal)
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA R.8 guidance (sub-acute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA R.8 guidance. Allometric scaling required (rat to humans)
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA R.8 guidance (interspecies rat to human)
- AF for intraspecies differences:
- 5
- Justification:
- ECHA R.8 guidance (intraspecies worker)
- AF for the quality of the whole database:
- 1
- Justification:
- Reliable OECD 421 study available.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
The Worker DNELs have been included in the REACH registration for completeness. No exposure assessment has been conducted as the substance is not present in concentrations which would lead to polymers being classified as hazardous under the CLP regulation. No performance of the exposure assessment is further supported with 3 documents attached in Section 13.2 of this REACH registration.
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:
- hazard unknown but no further hazard information necessary as no exposure expected
Additional information - General Population
As the substance is imported into the EU/EEA as a monomer bound in polymer, there is no potential for exposure of the substance itself to the general population. Accordingly, no general population DNELs are calculated for this substance.
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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