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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-328-4 | CAS number: 105-76-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.28 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):
- 9
- Modified dose descriptor starting point:
- LOAEC
- Explanation for the modification of the dose descriptor starting point:
- Based on the low vapor pressure of DBM and the general lack of significant exposure seen with this product in the workplace, the dose descriptor starting point selected was via inhalation toxicity but using the most sensitive endpoint effect to address any possible exposure due to inhalation in the work place.
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.28 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 9
- Dose descriptor:
- LOAEC
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 3
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:
- 0.42 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):
- 72
- Modified dose descriptor starting point:
- LOAEL
- AF for differences in duration of exposure:
- 6
- AF for other interspecies differences:
- 3
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.2 mg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 27
- Modified dose descriptor starting point:
- LOAEL
- AF for other interspecies differences:
- 3
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 3
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.12 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 9
- Dose descriptor:
- other: LOAEL
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Value:
- 4.13 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 9
- Dose descriptor starting point:
- other: LOAEL
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 3
- AF for the quality of the whole database:
- 3
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The assessment factors were selected based on the ECETOC Draft Guidance on Asseesment Factors to Derive DNELs (2010) and ECETOC Derivation of Assessment Factors for Human Health Risk Assessment (2003).
Acute DNELs - since the substance was determined to be a slight to well defined dermal and eye irritant and skin sensitizer, DNELs were derived using the skin sensitization data.
Long-Term DNEL - All long-term DNELs were derived using the most reliable available data.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard 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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard 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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- LOAEL
- AF for differences in duration of exposure:
- 2
- AF for other interspecies differences:
- 4
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Justification:
- from subacute to chronic
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The assessment factors were selected based on the ECETOC Guidance on Asseesment Factors to Derive DNELs (2010). However, the calculations or conversion needed were done according to the REACH guideline (R.8) for DNELs.
Acute DNELs - As described in the guidance on information requirements and chemical safety report (Chapter R.8, page 106), DNELs for acute toxicity should only be derived if an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures, in this case, for the general population. The long-term DNEL via oral exposure is considered sufficient to ensure that skin irritation and skin sensitation do not occur and the end uses of this substance suggest that there is no reason of concern for the general population via dermal and/or inhalation during short or long-term exposure. There is not need to derive a DNEL for acute toxicity for dermal and/or inhalation effects due to short term and long-term exposure, and the long-term DNEL via oral exposure should be sufficient. This is in accordance with REACH Annex I 1.4 Step 4: Identification of DNEL(s) where is stated that DNEL(s) should be established for e.g., likely routes and for the relevant human exposure.
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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