Registration Dossier
Registration Dossier
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EC number: 300-496-1 | CAS number: 93940-97-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.9 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:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 123 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 oral NOAEL of 100 mg/kg bw/day, obtained in the key sub-chronic reüeated dose toxicity study (OECD TG 408) in Wistar rats. The NOAECcorr. is calculated as follows:
- standard respiratory volume rat = 0.38 m³/kg/8h
- standard respiratory volume human = 6.7 m³/8h
- worker respiratory volume = 10 m³/8h
- absorption (oral, rat) = 50 % (default)
- absorption (inhalative, human) = 100 % (default)
- experimental exposure time = 7 days/week
- exposure time worker = 5 days/week
--> modified dose descriptor (corrected inhalatory NOAEC) = 100 mg/kg bw/day * (1/0.38 m³/kg/d) * (6.7 m³ (8h)/10 m³ (8h)) * (50%/100%) * (7 exposure days/week; rat/5 exposure days/week; worker) = 123 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: Extrapolation from sub-chronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA REACH Guidance: no additional factor needed for extrapolation from oral to inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance: default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance: default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance: good quality of data base
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance: default factor
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:
- 1.4 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 140 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 oral NOAEL of 100 mg/kg bw/day, obtained in the key sub-chronic repeated dose toxicity study (OECD TG 408) in Wistar rats. The NOAELcorr. is calculated as follows:
- absorption (oral, rat) = 50 % (default)
- absorption (dermal, human) = 50 % (default)
- experimental exposure time = 7 days/week
- exposure time worker = 5 days/week
--> modified dose descriptor (corrected dermal NOAEL) = 100 mg/kg bw/day * (50%/50%) * (7 exposure days/week; rat/5 exposure days/week; worker) = 140 mg/kg bw/day.
- 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: Extrapolation from sub-chronic to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH Guidance: default factor for extrapolation from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH Guidance: default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH Guidance: default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA REACH Guidance: good quality of data base
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA REACH Guidance: default factor
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)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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:
- 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
No consumer uses were identified. The general population does not get in contact with the substance. Therefore, in accordance with the REACH legislation (regulation (EC) No 1907/2006, Annex I, 1.4.1), no DNEL has to be derived for the 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.
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