Registration Dossier
Registration Dossier
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EC number: 679-514-8 | CAS number: 154279-60-4
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.12 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.03 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Derivation of DNELs – workers
Derivation of DNELs for acute exposure
DNEL – acute – systemic – dermal route
This DNEL has not been calculated as it is covered by long-term DNEL.
DNEL – acute – systemic – via inhalation
This DNEL has not been calculated as it is covered by long-term DNEL.
DNEL – acute – local – dermal route
Such a DNEL would be relevant for workers with existing contact allergy to Clearlink1000. However, these persons should be protected from the exposure to Clearlink 1000. Thus, this DNEL will not be calculated.
DNEL – acute – local – via inhalation
No reliable dose-descriptor available for this endpoint. The substance is not volatile and the method of application does not include high peak exposure. Also, the use of PPEs is expected with corrosive substances. Thus, the acute exposure via inhalation is not significant.
Derivation of DNELs for long-term exposure
DNEL - long term - local - dermal route
Qualitative approachs has been taken for this endpoint as there are no reliable dose-descriptor available for this endpoint and the use of PPEs are expected with corrosive substances.
DNEL - long term - local - inhalation route
Qualitative approachs has been taken for this endpoint as there are no reliable dose-descriptor available for this endpoint and the use of PPEs are expected with corrosive substances.
DNEL – long-term – systemic – dermal route
Relevant dose-descriptor for the endpoint: NOAEL systemic 10 mg/kg bw/day, sub acute oral gavage study in rats by F.M. van Otterdijk et al. 2011.
Correction of starting point
Route of exposure (oral versus dermal exposure): systemic bioavailability by dermal and oral route is assumed to be the same, therefore no correction is necessary for route-to-route extrapolation. NOAEL 10 mg/kg bw/day
Assessment factors according to ECHA 2010 (Guidance R.8)
Interspecies differences: allometric scaling factor 4
Interspecies, remaining differences: default assessment factor 2.5
Intraspecies differences: default assessment factor of 5 for workers.
Differences in duration of exposure: from sub-acute to chronic: default assessment factor 6
Issues related to dose-response: the starting point for the DNEL calculation is a NOAEL; no assessment factor.
Quality of whole database: default assessment factor 1
Overall assessment factor: (4 x 2.5 x 5 x 6 x 1) =300
DNEL worker chronic systemic by dermal route = 10 mg/kg bw/day / 300 =0.03 mg/kg bw/day
DNEL – long-term – systemic – via inhalation
Relevant dose-descriptor for the endpoint: NOAEL systemic 10 mg/kg bw/day, sub acute oral gavage study in rats by F.M. van Otterdijk et al. 2011.
Correction of starting pointRoute of exposure (oral versus inhalation exposure): systemic bioavailability is assumed to be 50% by oral route and 100% via inhalation. 10 mg/kg bw/day x (1/2) = 5 mg/kg bw/day
To convert the NOAEL to the air concentration for humans the NOAEL is divided by 0.38 m3/kg (8 hours exposure for workers)
Additional correction for inhalative volume for workers: 6.7 m3 for base level/ 10 m3 for light activity
Corrected value: 5 mg/kg bw/day / 0.38 m3/kg bw x (6.7m3 / 10m3) = 8.8 mg/m3
Assessment factors according to ECHA 2010 (Guidance R.8)
Interspecies, remaining differences: default assessment factor 2.5
Intraspecies differences: default assessment factor of 5 for workers.
Differences in duration of exposure: from sub-acute to chronic: default assessment factor 6
Issues related to dose-response: thestartingpoint for the DNEL calculation is a derived NOAEC; no assessment factor.
Quality of whole database: default assessment factor 1
Overall assessment factor: (2.5 x 5 x 6 x 1) =75
DNEL worker chronic systemic by inhalation route =8.8 mg/m3 /75=0.12 mg/m3
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 but no further hazard information necessary as no exposure expected
Additional information - General Population
DNEL values have not been derived for general population because the substance is not on the market for consumers.
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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