Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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.
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.
