Registration Dossier
Registration Dossier
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EC number: 203-700-6 | CAS number: 109-74-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.53 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13.22 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The most sensitive endpoint was the 90-day oral study where the rat NOAEL was 15 mg/kg/day for males and 25 mg/kg/day for females. As it is not reasonable to set sex-specific DNEL’s in a work environment, the 15 mg/kg/day value is used for both sexes.
The oral dose was converted to inhalation by dividing by 0.38 m3/kg BW ( for an 8 hour exposure) = 39.47 mg/m3. The was corrected for default bioavailability (100% oral to 50% inhalation) by dividing by 2, = 19.74 mg/m3. This was corrected for light work by multiplying by 0.67, = 13.22 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 2
- Justification:
- correction for subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No scaling for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 0.14 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14.07 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The most sensitive endpoint was the 90-day oral study where the rat NOAEL was 15 mg/kg/day for males and 25 mg/kg/day for females. As it is not reasonable to set sex-specific DNEL’s in a work environment, the 15 mg/kg/day value is used for both sexes.
The oral dose was converted from a 7 day exposure in the rat study to a 5 day work wee exposure by multiplying by 1.4 (15*1.4= 21 mg/kg/day). This was corrected for light work by multiplying by 0.67 (21* 0.67 = 14.07.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value
- AF for other interspecies differences:
- 5
- Justification:
- Default value
- AF for intraspecies differences:
- 2.5
- Justification:
- Default value
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
No DNEL for acute/short-term exposure via dermal route is needed, because the acute systemic toxicity of N-Butyronitrile by dermal route is low (LD50 > 2000 mg/kg bw). The long-term systemic DNEL is sufficient to ensure that acute systemic effects do not occur, provided high-peak acute exposure can be avoided.
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
DNEL Derivations for n-Butyronitrile (NBN)
General Population: As NBN is only used as in industrial product, with limited uses and is available to the general population, DNEL values for the general population were not calculated.
Workers:
Long-term
Inhalation
- The most sensitive endpoint was the 90-day oral study where the rat NOAEL was 15 mg/kg/day for males and 25 mg/kg/day for females. As it is not reasonable to set sex-specific DNEL’s in a work environment, the 15 mg/kg/day value is used for both sexes.
- The oral dose was converted to inhalation by dividing by 0.38 m3/kg BW ( for an 8 hour exposure) = 39.47 mg/m3. The was corrected for default bioavailability (100% oral to 50% inhalation) by dividing by 2, = 19.74 mg/m3. This was corrected for light work by multiplying by 0.67, = 13.22 mg/m3.
- For the assessment factors, the following were used: 1 for interspecies (no allometric scaling for inhalation), 5 for intraspecies, 2 for subchronic to chronic and 2.5 for remaining interspecies for a total of 25. 13.22/25 = 0.53 mg/m3.
Dermal:
-- The most sensitive endpoint was the 90-day oral study where the rat NOAEL was 15 mg/kg/day for males and 25 mg/kg/day for females. As it is not reasonable to set sex-specific DNEL’s in a work environment, the 15 mg/kg/day value is used for both sexes.
- The oral dose was converted from a 7 day exposure in the rat study to a 5 day work wee exposure by multiplying by 1.4 (15*1.4= 21 mg/kg/day). This was corrected for light work by multiplying by 0.67 (21* 0.67 = 14.07.
- Adjustment factors were 5 for intraspecies, 4 for allometric scaling, 2.5 for remaining interspecies and 2 for subchronic to chronic (100 total).
- The DNEL is 14.07/100 = 0.14 mg/kg/day
Oral:
Oral DNEL’s are not developed for workers.
Acute DNEL’s
- According to REACH Appendix R.8-8, Acute Toxicity, an acute DNEL is only developed if the long-term DNEL is not adequate for worker protection and there is evidence of a “peak exposure”. NBN is a industrial chemical is that normally used in closed systems. Any sort of exposure is highly discouraged, so there should never be a “peak exposure” situation, and the long-term DNEL should be protective.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
N-Butyronitrile is used exclusively in industry so exposure to the general population is not a valid parameter.
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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