Registration Dossier
Registration Dossier
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EC number: 216-940-1 | CAS number: 1704-62-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.7 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 617.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the inhalation route available. Therefore, the worker-DNEL long-term for inhalation route - systemic is derived from the NOAEL of 250 mg/kg bw/day, obtained in the Subchronic Repeated Dose Toxicity Study in Wistar rats. The NOAECcorr. is calculated as follows:
- standard respiratory volume (rat) = 0.38 m³/kg (8h exposure)
- standard respiratory volume (human) = 6.7 m³/person (8h exposure)
- worker respiratory volume = 10 m³/person (8h exposure)
--> modified dose descriptor (corrected inhalatory NOAEC) = oral NOAEL/0.38 x (6.7/10) x (7 exposure days/week; rat/5 exposure days/week; worker) = 617.1 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation.
- 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 (good/standard quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 4.9 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 488.8 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are no adequate experimental data on the dermal route available. Therefore, the worker-DNEL long-term for dermal route - systemic is derived from the NOAEL of 250 mg/kg bw/day, obtained in the Subchronic Repeated Dose Toxicity Study in Wistar rats. The NOAELcorr. is calculated as follows:
- absorption (oral, rat) = 100 % (default)
- absorption (dermal, rat) = 71.6 % (see also IUCLID chapter 7.1)
--> modified dose descriptor (corrected dermal NOAEL) = oral NOAEL/71.6 x 100 x (7 exposure days/week; rat/5 exposure days/week; worker) = 488.8 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- 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 (good/standard quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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)
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:
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
There are adequate experimental data on the oral route available. Therefore, the general population-DNEL long-term for oral route - systemic is derived from the NOAEL of 250 mg/kg bw/day, obtained in the Subchronic Repeated Dose Toxicity Study in Wistar rats. The NOAELcorr. is calculated as follows:
- absorption (oral, rat) = 100 % (default)
--> modified dose descriptor (corrected oral NOAEL) = oral NOAEL/100 x 100 = 250 mg/kg bw
- AF for dose response relationship:
- 1
- Justification:
- ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- 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 (good/standard quality of the database)
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance
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
In general, no exposure of the general population to the registered substance is expected.
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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