Registration Dossier
Registration Dossier
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EC number: 205-524-5 | CAS number: 142-16-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- other: 529 mg/m³ cNOAEC
- Explanation for the modification of the dose descriptor starting point:
Route to route extrapolation is necessary, as the original route of the study used in the estimation of the DNEL was conducted via oral.
- AF for dose response relationship:
- 1
- Justification:
- Study design includes dose range considered adequate to address potential dose respose.
- AF for differences in duration of exposure:
- 6
- Justification:
- Duration of exposure of original study combined with dose level and corrected NOAEC are considered adequate to address work exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- standard animal study conducted in rats
- AF for intraspecies differences:
- 5
- Justification:
- standars animal study
- AF for the quality of the whole database:
- 1
- Justification:
- dataset is adequate for evaluation of the substance
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:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 120
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
Based on the a 28 -day repeated-dose oral toxicity study in Sprague-Dawley rats provided a NOAEL of 300 mg/kg bw/day. Assuming 100% absorption, the NOAEL of 300 mg/kg bw/day was chosen as startpoint for the DNEL derivation.
- AF for dose response relationship:
- 1
- Justification:
- Study design for a 28-day oral repeated dose provided a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- Duration of exposure of original study combined with dose levels considered are adequate to address work exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- REACH Guidance for DNEL, when convert oral NOAEL rat (in mg/kg bw/day) into dermal N(L)OAEL rat (in mg/kg
bw/day) asks for interspecies differences to apply factor for allometric scaling (4 for rat). - Justification:
- standard animal study conducted in rats
- AF for intraspecies differences:
- 5
- Justification:
- standard animal study
- AF for the quality of the whole database:
- 1
- Justification:
- dataset is adequate for evaluation of the substance
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
Short Term DNELs - Since acute DNELs for workers should only be derived in case an acute toxicity hazard (leading to C&L) has been identified and the potential for peak exposure is unlikely, it has been concluded that these DNELs are not required for the complete evaluation of this substance.
High peak exposure are usually assessed for the inhalation route (ECHA Guidance R.8, page 106), a valued of 5000 mg/m³ for acute inhalation toxicity was selected to be used as surrogate of dibutyl maleate. In addition, the lack of toxicity in the oral acute study, the low vapor pressure and the general lack of significant effects seen with DOM in the workplace indicate low level of concern.
Long-Term DNELs - All long-term DNELs were calculated using the most reliable data available. The ECETOC (2010) Draft Default Assessment Factors from animal data were selected for the DNEL derivation. Also, the ECETOC Guidance for Assessment Factors to derive DNELs (2003) was applied.
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:
- no hazard 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
In accordance with Annex I (1.4 Step 4) of the REACH regulation there is no need to derive DNEL(s) for the general population when there is neither direct nor indirect exposure (via environment) to consumers from the manufactured substance through its uses at the manufacturing site and any downstream uses for the production of polymers and chemicals.
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.
