Registration Dossier
Registration Dossier
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EC number: 455-890-7 | CAS number: 6607-41-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 21.16 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):
- 12.5
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.48 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on repeated exposure by inhalation.
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL is used as starting point.
- AF for differences in duration of exposure:
- 1
- Justification:
- Effect level is based on a reproduction study and can therefore be considered to be chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Respiratory interspecies differences are fully covered by the factors used for route to route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- The ECHA REACH TG default value was used for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- The ECHA REACH TG default value for the relatively homogenous group "worker" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 6 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):
- 50
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- There are no relevant experimental data on the systemic effects as a results of dermal exposure.
- AF for dose response relationship:
- 1
- Justification:
- A NOAEL is used as starting point.
- AF for differences in duration of exposure:
- 1
- Justification:
- Effect level is based on a reproduction study and can therefore be considered to be chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The ECHA REACH TG default allometric scaling factor for the interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- The ECHA REACH TG default value was used for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- The ECHA REACH TG default value for the relatively homogenous group "workers" is used.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient.
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Acute exposure – workers
Acute / short-term exposure – local and systemic effects
- Dermal: The DNEL acute dermal does not appear relevant for Risk Characterisation - no acute local or systemic effects are anticipated.
- Inhalation: The DNEL acute inhalation does not appear relevant for Risk Characterisation - no acute local or systemic effects are anticipated.
Long-term exposure – workers
Long-term exposure – local and systemic effects
Dermal long-term systemic:
For dermal the NOAEL of 300 mg/kg bw/day was not adjusted for route to route extrapolation assuming that dermal absorption will not be higher than oral absorption. Therefore the point of departure is 300 mg/kg. This is then divided by a factor 4 for allometric scaling from rat to human multiplied by, the additional factor for interspecies differences of 2.5, the assessment factor intra-species variability for worker of 5, the factor for duration is 1 (as the end point on which the 300 mg/kg is based is for developmental toxicity and therefore not influenced the duration of the study). The factor for the quality of the data was 1. So this gives 300 / (4* 2.5 * 5 * 1* 1) = 6 mg/m3.
Inhalation long-term systemic:
For inhalation the NOAEL of 300 mg/kg bw/day was adjusted for the difference in respiration rate relative to bodyweight from rats to humans. For workers this gives a NOAEC of 300 * (1/0.38) * (6.7/10) = 528.95 mg/m3. This NOAEC is divided by 2 (ECHA factor to extrapolate from oral to inhalation) to give a point of departure of 264.48 mg/m3. This is then divided by the additional factor for interspecies differences of 2.5 multiplied by the assessment factor intra-species variability for worker of 5, the factor for duration is 1 (as the end point on which the 300 mg/kg is based is for developmental toxicity and therefore not influenced the duration of the study). The factor for the quality of the data was 1. So this gives 264.48 / (2.5 * 5 * 1* 1) = 21.16 mg/m3.
Inhalation and dermal long-term local:
The DNEL long-term local, dermal and inhalation cannot be derived as no long-term data is available for these routes.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
No exposure to general population expected.
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