Registration Dossier
Registration Dossier
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EC number: 700-064-6 | CAS number: 2105830-60-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.9 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 529 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Per REACH Guidance 8.4.2 (Example R. 8-2 Workers), the oral NOAEL of 300 mg/kg/day ( Reproduction / Developmental Toxicity Screening Test) was converted to an inhalation equivalent:
300 mg/kg/day ÷ 0.38 m3/kg bw (8 h exposure – rat) × 6.7 m3 (8 h exposure – human) ÷ 10 m3 (worker respiratory volume [wRV] - 8 h) = 529 mg/m3
- AF for dose response relationship:
- 2
- Justification:
- According to REACH Guidance (R.8.4.2), in the case of oral-to-inhalation extrapolation, and in the absence of route-specific information on the starting route, a default factor of 2 should be included (i.e. the absorption percentage for the starting route is half that of the end route). The inclusion of factor of 2 means that 50% (instead of 100%) absorption is assumed for oral absorption, and 100% for inhalation. A default factor of 2 is appropriate per REACH Guidance R.8.4.2.
- AF for differences in duration of exposure:
- 6
- Justification:
- A factor allowing for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration needs to be considered taking into account that a) in general the experimental NOAEL will decrease with increasing exposure times and b) other and more serious adverse effects may appear with increasing exposure times. A default factor of 6 (sub-acute to chronic exposure) is appropriate per REACH Guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling extrapolates doses according to an overall assumption that equitoxic doses scale with body weight. A default factor of 4 (rat to human) is appropriate per REACH Guidance R.8.4.3.1.
- AF for other interspecies differences:
- 2.5
- Justification:
- The standard procedure for threshold effects would be, as a default, to correct for differences in metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences. A default factor of 2.5 is appropriate per REACH Guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill. A default factor of 5 is appropriate per REACH Guidance R.8.4.3.3.
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/m³
- Most sensitive endpoint:
- sensitisation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: Derived from an ocupational exposure limit
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- AF for differences in duration of exposure:
- 6
- Justification:
- A factor allowing for differences in the experimental exposure duration and the duration of exposure for the population and scenario under consideration needs to be considered taking into account that a) in general the experimental NOAEL will decrease with increasing exposure times and b) other and more serious adverse effects may appear with increasing exposure times. A default factor of 6 (sub-acute to chronic exposure) is appropriate per REACH Guidance R.8.4.3.1.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling extrapolates doses according to an overall assumption that equitoxic doses (when expressed in mg/kg bw/day) scale with body weight. A default factor of 4 (rat to human) is appropriate per REACH Guidance R.8.4.3.1.
- AF for other interspecies differences:
- 2.5
- Justification:
- The standard procedure for threshold effects would be, as a default, to correct for differences in metabolic rate (allometric scaling) and to apply an additional factor of 2.5 for other interspecies differences. A default factor of 2.5 is appropriate per REACH Guidance R.8.4.3.1.
- AF for intraspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill. A default factor of 5 is appropriate per REACH Guidance R.8.4.3.3.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 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
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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