Registration Dossier
Registration Dossier
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EC number: 201-029-3 | CAS number: 77-47-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.034 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.84 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In order to derive DNELs from a repeated-dose toxicity study by inhalation, a conversion must be made in order to take into account the differences between experimental and human exposure.
- Workers: As the NOAEC was obtained on rats exposed 6 h/d to the substance, it must be corrected for an inhalation exposure of workers, taking into account that workers are considered to be working 8h/d, with inhalative volumes for 8h/d defined in the ECHA Guidance at 6.7m3 for base level activity and 10m3 for light activity.
Corrected NOAEC(inhalation) = NOAEC(inhalation) * (exp.cond.rat / exp.cond.human)
Corrected NOAEC(inhalation) = 1.67 mg/m3 * (6 h/d / 8 h/d) * (6.7 m3 / 10 m3)
Corrected NOAEC(inhalation) = 0.84 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.44 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- other: LC50
- Value:
- 18 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The European Union (2007) considered as acceptable to determine the Margin of Safety for an acute inhalation exposure to the registered substance based on a LC50 of 18 mg/m3. Therefore this value was used a starting point and was applied the relevant assessment factors.
Reference:
European Union (2007) Risk Assessment Report. Hexachlorocyclopentadiene. CAS No: 77-47-4. EINECS No: 201-029-3. Final Approved Version.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.028 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 180
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that the dermal absorption of the substance will be similar between human and rabbit, therefore the NOAEL(dermal) for systemic effects from the subacute repeated-dose toxicity by the dermal route does not need to be converted.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute exposure to chronic exposure
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbits to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.167 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEC
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that the dermal absorption of the substance will be similar between human and rabbit, therefore the NOAEL(dermal) for systemic effects from the subacute repeated-dose toxicity by the dermal route does not need to be converted.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbits to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.008 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.42 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In order to derive DNELs from a repeated-dose toxicity study by inhalation, a conversion must be made in order to take into account the differences between experimental and human exposure.
- General Population: As the NOAEC was obtained on rats, it must be corrected for an inhalation exposure of the general population, taking into account that the general population is considered as being exposed 24h/d.
Corrected NOAEC(inhalation) = NOAEC(inhalation) * (exp.cond.rat / exp.cond.human)
Corrected NOAEC(inhalation) = 1.67 mg/m3 * (6 h/d / 24 h/d)
Corrected NOAEC(inhalation) = 0.42 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to Chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.72 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- other: LC50
- Value:
- 18 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The European Union (2007) considered as acceptable to determine the Margin of Safety for an acute inhalation exposure to the registered substance based on a LC50 of 18 mg/m3. Therefore this value was used a starting point and was applied the relevant assessment factors.
Reference:
European Union (2007) Risk Assessment Report. Hexachlorocyclopentadiene. CAS No: 77-47-4. EINECS No: 201-029-3. Final Approved Version.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.014 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 360
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that the dermal absorption of the substance will be similar between human and rabbit, therefore the NOAEL(dermal) for systemic effects from the subacute repeated-dose toxicity by the dermal route does not need to be converted.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to Chronic
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbits to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 60
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that the dermal absorption of the substance will be similar between human and rabbit, therefore the NOAEL(dermal) for systemic effects from the subacute repeated-dose toxicity by the dermal route does not need to be converted.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 2.4
- Justification:
- Rabbits to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that the oral absorption of the substance will be similar between human and rat, therefore the NOAEL(oral) from the subchronic repeated-dose toxicity by the oral route does not need to be converted.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to Chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 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
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that the oral absorption of the substance will be similar between human and rat, therefore the NOAEL(oral) from the subchronic repeated-dose toxicity by the oral route does not need to be converted.
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats to Humans
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
