Registration Dossier
Registration Dossier
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EC number: 260-252-4 | CAS number: 56539-66-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 80 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 2 000 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default, exceptions do not apply
- AF for differences in duration of exposure:
- 2
- Justification:
- guidance R.8 default for subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable, see APPENDIX R. 8-2, part 2 example B3
- AF for other interspecies differences:
- 2.5
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 5
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 1
- Justification:
- key study was rated Klimisch 1
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
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:
- 6.25 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 625 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal endpoint is available; oral subchronic is the most sensitive endpoint.
A dermal absorption factor of 0.4 has been considered, see section toxicokinetics.
Dermal NOAEL = 250/0.4 = 625 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 2
- Justification:
- guidance R.8 default for subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 2.5
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 5
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 1
- Justification:
- key studies were rated Klimisch 1
- AF for remaining uncertainties:
- 1
- Justification:
- not justified, see above
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:
- low hazard (no threshold derived)
Additional information - workers
The typical pattern of worker and consumer exposure to 3-methoxy-3-methyl-butan-1-ol is low levels of exposure on a repeated basis. Short-term high exposures are considered unlikely given the high levels of control in place at sites formulating and using the substance. DNELs for long-term exposure are therefore adequate to protect against short-term exposures and no separate short-term DNELs are calculated.
The oral subchronic toxicity NOAEL of 250 mg/kg bw/day is selected as critical endpoint on the basis of haematological findings and clinical biochemistry and is used as point of departure for the derivation of dermal DNELs. This endpoint is considered the most sensitive one and representative for adverse effects observed in different species and different studies available.
The inhalation subchronic study is used as point of departure for the derivation of inhalatory DNELs.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 2 000 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 2
- Justification:
- guidance R.8 default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- inhalation study used
- AF for other interspecies differences:
- 2.5
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 10
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 1
- Justification:
- key study was rated Klimisch 1
- AF for remaining uncertainties:
- 1
- Justification:
- Study performed with exposure via inhalation
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
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:
- 3.1 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 625 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal endpoint is available; oral is the most sensitive endpoint. A dermal absorption factor of 0.4 was applied to the oral NOAEL of 250 mg/kg bw/day, see section toxicokinetics. Dermal NOAEL = 250 /0.4 = 625 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 2
- Justification:
- guidance R.8 default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 2.5
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 10
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 1
- Justification:
- key studies were rated Klimisch 1
- AF for remaining uncertainties:
- 1
- Justification:
- an assessment factor for remaining differences is not justified, see above
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
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
no differences in oral absorption assumed.
- AF for dose response relationship:
- 1
- Justification:
- guidance R.8 default
- AF for differences in duration of exposure:
- 2
- Justification:
- guidance R.8 default
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- guidance R.8 default
- AF for other interspecies differences:
- 2.5
- Justification:
- guidance R.8 default
- AF for intraspecies differences:
- 10
- Justification:
- guidance R.8 default
- AF for the quality of the whole database:
- 1
- Justification:
- key studies were rated Klimisch 1
- AF for remaining uncertainties:
- 1
- Justification:
- an assessment factor for remaining differences is not justified, see above
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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.
