Registration Dossier
Registration Dossier
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EC number: 212-305-8 | CAS number: 780-69-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: substance-specific, see discussion
- Overall assessment factor (AF):
- 33
- Dose descriptor starting point:
- NOAEC
- Value:
- 620 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 337.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an inhalation NOAEL (600 mg/m³) observed in a repeated dose inhalation toxicity study with a read across substance (OECD 412; 1981).
To correct the interspecies difference between rat and human the no observed effect level has to be corrected as follows:
Corrected starting point for the inhalative route for workers:
= NOAEL(inhalation) * exposure condition rat/exposure condition human
= 620 mg/m³ * (6.5h/day / 8h/day) * (6.7 m³ (8h) / 10 m³ (8h) = 337.5 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- study is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- based on a subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences were taken into account for the conversion of the rat oral NOAEL into a corrected inhalatory NOAEC considering allometric scaling for the respiratory volumes (modification of the dose descriptor starting point). Thus, no additional AF is applicable.
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 2.2
- Justification:
- substance-specific, see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- based on a high-quality study
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: substance-specific, see discussion
- Overall assessment factor (AF):
- 132
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 56 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No data are available for the dermal route. However, reliable data are available for the oral route.
Corrected starting point for the dermal route for workers:
Dermal NOAEL = oral NOAEL*ABS(oral)/ABS(dermal) * (7 days exposure rat/5 days exposure worker) = 40 mg/kg bw/day *(1/1) * 1.4 = 56 mg/kg bw/day. It is assumed that oral and dermal absorption rates are equal.
- AF for dose response relationship:
- 1
- Justification:
- based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- based on a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default
- AF for intraspecies differences:
- 2.2
- Justification:
- substance-specific (see discussion)
- AF for the quality of the whole database:
- 1
- Justification:
- based on high-quality study
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- DNEL (Derived No Effect Level)
- Value:
- 3.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: substance-specific, see discussion
- Overall assessment factor (AF):
- 48
- Dose descriptor starting point:
- NOAEL
- Value:
- 620 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 167.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The calculation of the DNEL is based on an inhalation NOAEL observed from a subacute repeated dose inhalation study (OECD 412) in rats.
To correct the interspecies difference between rat and human the no observed effect level has to be corrected as follows:
Corrected starting point for the inhalative route for general population:
= NOAELinhalation * exposure conditions rat / exposure conditions human
= 620 mg/m³ * (6.5h/day / 24h/day) = 167.9 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The dose descriptor starting point is based on a NOAEL.
- AF for differences in duration of exposure:
- 6
- Justification:
- based on a subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 3.2
- Justification:
- substance-specific, see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- base on high-quality study
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: substance-specific, see discussion
- Overall assessment factor (AF):
- 192
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No data are available for the dermal route. However, reliable data are available for the oral route.
Corrected starting point for the dermal route for workers:
Dermal NOAEL = oral NOAEL*ABS(oral)/ABS(dermal) = 40 mg/kg bw/day *(1/1) = 40 mg/kg bw/day. It is assumed that oral and dermal absorption rates are equal.
- AF for dose response relationship:
- 1
- Justification:
- based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- based on a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 3.2
- Justification:
- substance-specific, see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- based on high-quality data
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.21 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: substance-specific, see discussion
- Overall assessment factor (AF):
- 192
- Dose descriptor starting point:
- NOAEL
- Value:
- 40 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- based on a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default for rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 3.2
- Justification:
- substance-specific, see discussion
- AF for the quality of the whole database:
- 1
- Justification:
- based on high quality data
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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:
- 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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