Registration Dossier
Registration Dossier
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EC number: 288-509-6 | CAS number: 85736-97-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.58 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: informed assessment factors
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 105.79 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL for repeated dose toxicity of 120 mg/kg bw/d
Modification of starting point involves conversion of rat oral exposure to human inhalation exposure using ECHA Ch R8, Fig. 8.3. Human NOAEC = Oral NOAEL X 1/0.38 m³/kg/d X 0.5 absn. Default X 6.7/10 = 105.79 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for extrapolation from sub-chronic to chronic (ECHA 2008).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.
- AF for intraspecies differences:
- 5
- Justification:
- default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The key studies were of high quality. No adjustment is required.
- 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:
- 3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: informed assessment factors
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL for repeated dose toxicity of 120 mg/kg bw/d
Modification of starting point involves conversion of rat oral exposure to human dermal exposure using ECHA Ch R8, Ex. B5, page 69. Human NOAEL = Oral NOAEL X 1 (Absorption factor for oral to dermal route =1; ECHA Ch R8. page 25.)
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for extrapolation from sub-chronic to chronic (ECHA 2008).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans AF 4 (ECHA 2008).
- AF for other interspecies differences:
- 1
- Justification:
- Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.
- AF for intraspecies differences:
- 5
- Justification:
- default AF (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- The key studies were of high quality. No adjustment is required.
- 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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: informed assessment factors
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.17 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL for repeated dose toxicity of 120 mg/kg bw/d
Modification of starting point involves conversion of rat oral exposure to human inhalation exposure using ECHA Ch R8, Fig. 8.3. Human NOAEC = Oral NOAEL X 1/1.15 m³/kg/d X 0.5 absn. = 52.17 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF for extrapolation from sub-chronic to chronic (ECHA 2008).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.
- AF for intraspecies differences:
- 10
- Justification:
- default AF (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- The key studies were of high quality. No adjustment is required.
- 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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: informed assessment factors
- Overall assessment factor (AF):
- 80
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Starting point: NOAEL for repeated dose toxicity of 120 mg/kg bw/d
Modification of starting point involves conversion of rat oral exposure to human dermal exposure using ECHA Ch R8, Ex. B5, page 69. Human NOAEC = Oral NOAEL X 1 (Absorption factor for oral to dermal route =1; ECHA Ch R8. page 25.)
- AF for dose response relationship:
- 1
- Justification:
- The NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- default AF for extrapolation from sub-chronic to chronic (ECHA 2008).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans AF 4 (ECHA 2008).
- AF for other interspecies differences:
- 1
- Justification:
- Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected.
- AF for intraspecies differences:
- 10
- Justification:
- default AF (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- The key studies were of high quality. No adjustment is required
- 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: informed assessment factors
- Overall assessment factor (AF):
- 80
- Dose descriptor starting point:
- NOAEL
- Value:
- 120 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
no route to route extrapolation required
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point. The original NOAEL is reliable. No adjustment is required.
- AF for differences in duration of exposure:
- 2
- Justification:
- defauls AF for extrapolation sub-chronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to humans AF 4
- AF for other interspecies differences:
- 1
- Justification:
- Remaining differences factor of 2.5 (Ch R8 p.29/30) is not required to rapid metabolism of the parent ester to the alcohol and MAA so no TD differences between rats and humans are expected
- AF for intraspecies differences:
- 10
- Justification:
- default AF (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- The key studies were of high quality. No adjustment is required
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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.
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.
