Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 434-080-7 | CAS number: 208343-47-9
Toxicological Summary
Administrative data
Workers - 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:
- no hazard identified
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:
- 33.33 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the guidance document on dermal absorption (Sanco/222/2000 rev. 7, 2004) a 10 % dermal absorption is expected for the test substance as the the molecular weight is >500 g/mol and the logPow is >4.
The molecular weight and logPow were calculated to be 629.80 g/mol and 7.6 (25 °C), respectively.
In addition, guidance IR&CSA chapter R.7c (ECHA, 2017) describes dermal uptake to be low for a test substance, if water solubility is lower than 1 mg/l.
The water solubility of the test substance was experimentally determined to be <0.046 mg/L at 20°C and at pH 5.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation is a NOAEL. Therefore, the default assessment factor 1 is chosen.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default AF of 6 for time extrapolation between sub-acute (28d) to chronic study duration is set in line with the REACH guidance R.8.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default AF of 4 for rats for interspecies differences is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default AF of 2.5 for other interspecies differences, i.e. toxicokinetic/-dynamic differences is set in line with the REACH guidance R.8.
- AF for intraspecies differences:
- 5
- Justification:
- The default factor of 5 for workers is set in line with the REACH guidance R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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
1. Identification of relevant dose descriptor
In a 28 d study performed in rat (OECD guideline 407), the substance did not cause mortalities, signs of toxicity or any other changes or abnormalities. The NOEL is considered to be 1000 mg/kg bw/d.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
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:
- no hazard identified
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
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.67 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the guidance document on dermal absorption (Sanco/222/2000 rev. 7, 2004) a 10 % dermal absorption is expected for the test substance as the the molecular weight is >500 g/mol and the logPow is >4.
The molecular weight and logPow were calculated to be 629.80 g/mol and 7.6 (25 °C), respectively.
In addition, guidance IR&CSA chapter R.7c (ECHA, 2017) describes dermal uptake to be low for a test substance, if water solubility is lower than 1 mg/l.
The water solubility of the test substance was experimentally determined to be <0.046 mg/L at 20°C and at pH 5.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation is a NOAEL. Therefore, the default assessment factor 1 is chosen.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default AF of 6 for time extrapolation between sub-acute (28d) to chronic study duration is set in line with the REACH guidance R.8.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default AF of 4 for rats for interspecies differences is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default AF of 2.5 for other interspecies differences, i.e. toxicokinetic/-dynamic differences is set in line with the REACH guidance R.8.
- AF for intraspecies differences:
- 10
- Justification:
- The default factor of 10 for the general population is set in line with the REACH guidance R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL calculation is a NOAEL. Therefore, the default assessment factor 1 is chosen.
- AF for differences in duration of exposure:
- 6
- Justification:
- The default AF of 6 for time extrapolation between sub-acute (28d) to chronic study duration is set in line with the REACH guidance R.8.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default AF of 4 for rats for interspecies differences is used.
- AF for other interspecies differences:
- 2.5
- Justification:
- The default AF of 2.5 for other interspecies differences, i.e. toxicokinetic/-dynamic differences is set in line with the REACH guidance R.8.
- AF for intraspecies differences:
- 10
- Justification:
- The default factor of 10 for the general population is set in line with the REACH guidance R.8.
- AF for the quality of the whole database:
- 1
- Justification:
- The quality of the whole data base is considered to be sufficient and uncritical.
- AF for remaining uncertainties:
- 1
- Justification:
- The approach used for DNEL derivation is conservative. No further assessment factors are required.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
1. Identification of relevant dose descriptor
In a 28 d study performed in rat (OECD guideline 407), the substance did not cause mortalities, signs of toxicity or any other changes or abnormalities. The NOEL is considered to be 1000 mg/kg bw/d.
2. Mode of action
No non-threshold mode of action is associated with the test substance. In particular, the test substance has no genotoxic potential.
Calculation of DNEL bases upon Guidance Document on Dermal Absorption, European Commission, 2004 and Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health, may 2008
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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