Registration Dossier
Registration Dossier
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EC number: 270-821-9 | CAS number: 68478-46-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Conversion of the oral NOAEL rat into a corrected inhalatory NOAEC to assess human inhalation exposure is necessary to derive the correct starting point for the inhalation route for which no repeated dose toxicity study was carried out. In the case of oral-to-inhalation extrapolation, 50% (instead of 100%) absorption is assumed for oral absorption, and 100 % for inhalation.
The modification of the descriptor starting point is conducted according to Fig. R.8-3 of ECHA Guidance Chapter R.8, chapter R.8 .4.2 of TGD (ECHA, 2012).
corrected inhalatory N(L)OAEC = oral N(L)OAEL * 1 / sRVrat * ABS oral rat/ ABS inhal-human * sRVhuman/ wRV
= oralN(L)OAEL * 1/ 0.38m3/kg/d * ABS oral_rat / ABS inhal_human * 6.7 m3 (8h) / 10m3 (8h)
= oralN(L)OAEL *2.6316 kg/m3 * 0.5 * 0.67
= 0.882 kg/m3* 100 mg/kg bw/d
= 88.2 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL. Thus, standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- A assessment factor 6 is suggested by the ECHA TGD for exposure duration from subacute (28 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences, however, as we have corrected the oral starting point to an inhalation NOAEC, the interspecies differences are already included and no further factor for allometric scaling applies (see TGD, ECHA Example B3 and Table R 8-4).
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R.4.3.1 of TGD (ECHA, Nov 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered to be necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.3 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Converting the oral NOAEL rat into a dermal NOAEL is necessary to derive the correct starting point for the dermal route for which no study was carried out.
As a worst case consideration dermal absorption is considered to be 100%.
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL. Thus, standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- A assessment factor 6 is suggested by the ECHA TGD for exposure duration from subacute (28 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- For intraspecies variability, the default assessment factor for worker for systemic effects is 5 (ECHA, Nov 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R.4.3.1 of TGD (ECHA, Nov 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered to be necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.2 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
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- no hazard identified
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:
- no hazard identified
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:
- 0.17 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assumptions: Absorption rat = Absorption human ; Frequency of exposure of rat (7d/wk) = Frequency of exposure of general population (7d/wk);
No correction of NOAEL neccessary as the expsoure of rats in the repeated dose toxicity study in rats was continuously (feeding study).
- AF for dose response relationship:
- 1
- Justification:
- Starting point for the DNEL calculation is a NOAEL. Thus, standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
- AF for differences in duration of exposure:
- 6
- Justification:
- An assessment factor 6 is suggested by the ECHA TGD for exposure duration from subacute (28 day) to chronic (see section R.8.4.3.1, Table R. 8-5) (ECHA, Nov 2012).
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- An allometric scaling factor of 4 is suggested by the ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov 2012) for interspecies differences.
- AF for other interspecies differences:
- 2.5
- Justification:
- A factor of 2.5 is suggested by the ECHA TGD (ECHA, Nov. 2012) for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- For intraspecies variability, the default assessment factor for the general population for systemic effects is 10 (ECHA, Nov 2012).
- AF for the quality of the whole database:
- 1
- Justification:
- Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R.4.3.1 of TGD (ECHA, Nov 2012).
- AF for remaining uncertainties:
- 1
- Justification:
- No further assessment factors are considered to be necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The test compound is generally not intended to be used by consumer. An exposure of the general population via the environment might occur through ingestion of foodstuff or drinking water. Therefore, an oral DNEL systemic, long-term for general population is derived.
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.
