Registration Dossier
Registration Dossier
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EC number: 230-257-6 | CAS number: 6990-43-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.79 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 134.27
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 152.2 mg/kg bw/day*(1/0.38 m³/kg bw/day)*0.67*(0.5/1) = 134.2 mg/m³. It is assumed that oral absorption rate is 50% of that of inhalation absorption. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- DNEL is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is 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
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The selected study is the most adequate and reliable study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.02 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 304.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (152.2 mg/kg bw/day)*(1/0.5) = 304.4 mg/kg bw/day. It is assumed that the dermal absorption rate is 50% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- DNEL is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The selected study is the most adequate and reliable study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
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
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
SUBSTANCE-TAILORED EXPOSURE DRIVEN TESTING
In accordance with Annex XI, Section 3 of Regulation (EC) 1907/2006, testing in accordance with Sections 8.7 of Annex VIII and/or IX was omitted, based on the exposure scenario(s) developed in the Chemical Safety Report, meeting the criteria set out in Annex XI Section 3.2(a).
In particular, in accordance with Annex XI Section 3.2 (a)(ii), the manufacturer or importer shall demonstrate and document that following condition is also fulfilled:
“a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes”
As required under Regulation (EC) 1907/2006, Annex XI, 3.2 (a)(ii), the appropriate DNELs were derived using the available data, and applied to derive Risk Characterisation Ratios (RCRs).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.44 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 66.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- NOAECcorr = NOAELoral*(1/1.15 m³/kg bw/day)*(ABSoral-rat/ABSinh-human) = 152.2 mg/kg bw/day*(1/1.15 m³/kg bw/day)*(0.5/1) = 66.2 mg/m³. It is assumed that oral absorption rate is 50% of that of inhalation absorption. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- DNEL is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is 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
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The selected study is the most adequate and reliable study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
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
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.51 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 304.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (152.2 mg/kg bw/day)*(1/0.5) = 304.4 mg/kg bw/day. It is assumed that the dermal absorption rate is 50% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
- AF for dose response relationship:
- 1
- Justification:
- DNEL is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The selected study is the most adequate and reliable study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
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
- 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:
- 0.25 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 152.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route extrapolation is required.
- AF for dose response relationship:
- 1
- Justification:
- DNEL is based on a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on a subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for rats
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The selected study is the most adequate and reliable study
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
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.
