Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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: 203-977-3 | CAS number: 112-49-2
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.5 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 525 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and inhalation routes; Human body weight of 70 kg/person; Daily respiration volume for a worker of 10 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- A clear dose response relation established in the original study.
- AF for differences in duration of exposure:
- 1
- Justification:
- The endpoint developmental toxicity is used as bases for DNEL. AF of 1 is normally used for this endpoint (i.e. In accordance with DENL derivation for 2-Methoxyethanol in Annex XV dossier).
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- The provided studies are considered fully reliable.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties 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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Comparable resorption for oral and dermal routes.
- AF for dose response relationship:
- 1
- Justification:
- A clear dose response relation established in the original study.
- AF for differences in duration of exposure:
- 1
- Justification:
- The endpoint developmental toxicity is used as bases for DNEL. AF of 1 is normally used for this endpoint (i.e. In accordance with DNEL derivation for 2-Methoxyethanol in Annex XV dossier).
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 5
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- The available data are considered as fully reliable.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties 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
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:
- other toxicological threshold
- Value:
- 0.5 µg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
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:
- other toxicological threshold
- Value:
- 1 µg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
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:
- 1.25 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- Dose descriptor starting point:
- NOAEL
- Value:
- 75 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75
- Explanation for the modification of the dose descriptor starting point:
No modification needed.
- AF for dose response relationship:
- 1
- Justification:
- A clear dose response relation established in the original study.
- AF for differences in duration of exposure:
- 1
- Justification:
- The endpoint developmental toxicity is used as bases for DNEL. AF of 1 is normally used for this endpoint (i.e. In accordance with DNEL derivation for 2-Methoxyethanol in Annex XV dossier).
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- The allometric scaling factor for rabbit given as 2.4 in ECHA REACH Guidance.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default
- AF for intraspecies differences:
- 10
- Justification:
- Default
- AF for the quality of the whole database:
- 1
- Justification:
- The provided studies are considered fully reliable.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties identified.
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.
