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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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: 202-697-9 | CAS number: 98-74-8
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.35 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:
- 176.32 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 100 mg/kg/day established in the combined 28-day repeated dose toxicity study/reproductive toxicity screening study (oral route, OECD 422; Van Otterdijk, 2018) was used to derive a DNEL long-term, systemic effects via the inhalation route. After route-to-route extrapolation from oral to inhalation, the dose descriptor starting point NOAEC is 176.3 mg/m³ = 100 mg/kg/day x 1/0.38 m³/kg/day x 0.67 x 1. The oral dose for rats was converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 hours exposure for workers). For workers, the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under respective conditions (6.7 m³ for base level, 10 m³ for light activity).In addition, the NOAEL needs to be divided by 1 as the bioavailability via the inhalation route is considered as 50% while for oral exposure this is assumed to be 50%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- Difference in study duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in the route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- Worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- Default assessment 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:
- 0.33 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:
- 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:
No long-term dermal toxicity study is available for the test substance. However, data from an oral combined repeated dose toxicity study with reproduction/developmental toxicity screening study (OECD 422; Van Otterdijk, 2018) could be used after extrapolation to the dermal route. The NOAEL was established at 100 mg/kg bw/day. For route-to-route extrapolation (oral to dermal), no default factor (i.e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption (50%).
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in study duration subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor
- AF for intraspecies differences:
- 5
- Justification:
- Worker population
- AF for the quality of the whole database:
- 1
- Justification:
- No need for further assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment 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:
- high 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:
- 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:
- no hazard identified
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
No DNEL is derived for the general population, as no exposure is foreseen for this substance.
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.
