Registration Dossier
Registration Dossier
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EC number: 219-351-8 | CAS number: 2422-91-5
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:
- 0.048 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation is a NOAEL according to ECHA Guidance (November 2012), R.8.4.3.1 the default assessment factor, as a standard procedure, is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- The assessment factor suggested by the ECHA TGD for exposure duration from subacute to chronic should be 6, but the relevant effect (port of entry toxicity) is deemed to be more concentration rather than dose dependent, thus the duration of exposure is likely to be of little consequence, and hence, time extrapolation would be inappropriate. In the depicted case no systemic effects were observed, and the observed local effects lead to LOAECs that does not give evidence for a major time-dependent change of the response threshold (for comparison LOAECacute vs. LOAECsubacute 1.9 : 3.9 mg/m³). On this basis it is not expected that a longer duration of the study would change the outcome and an AF of 1 is warranted.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- As long as route-to-route extrapolation is not needed, allometric scaling should not be applied in cases where doses in experimental animal studies are expressed as concentrations according to ECHA Guidance (November 2012), chapter R.8.4.3.1.
- AF for other interspecies differences:
- 1
- Justification:
- A factor 2.5 is suggested by the ECHA TGD for remaining interspecies differences, but justified deviations are possible. Rodents like the rat are in general more sensitive compared to humans as the rat’s ventilation frequency is higher. Therefore, as a general rule a AF of 1 for remaining interspecies differences provides sufficient protection.
- AF for intraspecies differences:
- 5
- Justification:
- According to ECHA Guidance (November 2012) Chapter R.8.4.3.1 the default AF to be applied for intraspecies differences in workers is 5.
- AF for the quality of the whole database:
- 1
- Justification:
- According to ECHA Guidance (November 2012) R.8.4.3.1 the default AF to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.
- AF for remaining uncertainties:
- 1
- Justification:
- For effects on the respiratory tract, where the mechanism of effect is direct chemical reactivity, no further kinetic considerations apply. Furthermore, in terms of dynamics, one might assume that animals and humans will respond to the insult in the same way. In this case, the default factor for remaining uncertainties of 2.5 could be reduced to 1 according to ECHA Guidance (November 2012), R.8.4.3.1.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.096 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- other: extrapolated from long tern 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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The assessment factor suggested by the ECHA TGD for exposure duration from subacute to chronic should be 6, but the relevant effect (port of entry toxicity) is deemed to be more concentration rather than dose dependent, thus the duration of exposure is likely to be of little consequence, and hence, time extrapolation would be inappropriate. In the depicted case no systemic effects were observed, and the observed local effects lead to LOAECs that does not give evidence for a major time-dependent change of the response threshold (for comparison LOAECacute vs. LOAECsubacute 1.9 : 3.9 mg/m³). On this basis it is not expected that a longer duration of the study would change the outcome and an AF of 1 is warranted.
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
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:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Exposure of the General Population (Consumer/humans via the environment) is expected to be negligible. As displayed in IUCLID section 3.6 all consumer uses are strongly advised against. Therefore the substance is not used in the public domain and exposure of consumers is thus not to be expected. Emissions of the substance in the environmental compartments water, air and soil are negligible therefore human exposure via environment can be considered as negligible as well.
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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