Registration Dossier
Registration Dossier
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EC number: 947-942-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.006 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 90
- Dose descriptor:
- LOAEC
- Value:
- 1 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- Since the starting point for the DNEL calculation is a LOAEL, a factor between 3 and 10 is suggested in ECHA Guidance Chapter R.8, 2012. In this case a factor 3 is chosen, because the effects at the low dose were slight, fully recovered with regard to the findings in BALF, and showed a tendency to recover after 4 weeks for the histopathology findings.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for duration extrapolation subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- According to ECHA Guidance Chapter R.8, 2012 allometric scaling should not be applied if the effects are not dependent on metabolic rate or systemic absorption, e.g. in the case of local effects, therefore AF 1 is chosen.
- AF for other interspecies differences:
- 1
- Justification:
- A factor 2.5 is suggested by ECHA Guidance Chapter R.8, 2012 for remaining interspecies differences, but justified deviations are possible. For local effects on respiratory tract it should be taken into account that rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. Particular in the repeated dose 90-days study a local irritant effect on the rat larynx was observed, which is known to be a common finding in rat inhalation studies and which is seen as an indicator of the especially high susceptibility of the rodent larynx to any mild irritant (Kaufmann et al., Exp. Toxicol. Pathol. 61, 591 - 603, 2009). Also the other effects observed at the effect level were solely local or rat specific secondary effects and indicated on irritancy as the primary Mode of Action. Therefore a factor of 1 is applied.
- AF for intraspecies differences:
- 5
- Justification:
- For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used.
- AF for the quality of the whole database:
- 1
- Justification:
- The default assessment factor to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.011 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 45
- DNEL extrapolated from long term DNEL
Workers - 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:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
For workers in industrial settings, which are exposed to the substance via inhalation, DNELs for acute and long-term inhalation have to be derived. For this purpose the available, fully reliable, repeated inhalation toxicity study (OECD TG 412) provides the point of departure for the DNEL derivation, which is a LOAEC in this case. Consequently, an additional assessment factor for dose response relationship has to be used (i.e. factor 3).
The reproductive toxicity screening with gavage administration reveals no specific systemic toxicity and confirms the repeated inhalation toxicity study as the relevant study to be used for risk assessment in the workplace.
In addition, the possible risk of skin sensitization has to be assessed. Since it is not possible with the available data to calculate a threshold for skin sensitization a qualitative approach is used: with respect to skin sensitization the substance is allocated to the high hazard band (cp. ECHA Guidance Part E: Risk characterisation, 2012).
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
No hazard is identified for the general population, since the substance is not used in the public domain and exposure of consumers is thus not to be expected.
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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