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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: 800-940-9 | CAS number: 35836-72-7
Toxicological information
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 159 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No dose descriptor is available for inhalation. It is therefore necessary to convert the available rat oral NOAEL (28-d study) into a correct starting point to obtain a DNEL for the relevant exposure pattern (worker, 8h/d, inhalation). In the absence of data, it is assumed that 50% absorption occurs by oral route. To secure a conservative NOAEL a maximum absorption (i.e. 100%) is assumed for the inhalation route. The rat Standard Respiratory Volume (SRV) for 8 h exposure is used to convert the oral NOAEL into an inhalatory NOAEL (sRVrat: 0.38 m3/kg bw/8h). An additional correction is added to take into account the worker's light activity in comparison with standard conditions (sRVhuman: 6.7 m3 for 8h exposure - worker with light activity, wRV: 10 m3 for 8h exposure). The corrected starting point is thus calculated as follows: corrected inhalatory NOAEC = oral NOAEL x (1/sRVrat) x (absorption oral rat/absorption inhalation human) x (sRVhuman/wRV); thus corrected inhalatory NOAEC for workers = 180.2 mg/kg bw/d x 0.5 x (1/0.38 m3/kg bw/8h) x (6.7 m3 for 8h exposure /10 m3 for 8h exposure) = 159 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for oral to inhalation extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differencies
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 180.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dose descriptor is available for dermal route. However, no additional factor is needed when performing oral to dermal extrapolation
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differencies
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 78 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 45
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- Justification:
- EC3 is considered as a NOAEL
- AF for differences in duration of exposure:
- 3
- Justification:
- Repeated (long term) exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not relevant for local effects
- AF for other interspecies differences:
- 1
- Justification:
- EC3 is considered as a NOAEL for humans
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for remaining uncertainties:
- 3
- Justification:
- Dermal integrity and exposure conditions (matrix effects)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 78 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No dose descriptor is available for inhalation. It is therefore necessary to convert the available rat oral NOAEL (28-d study) into a correct starting point to obtain a DNEL for the relevant exposure pattern (general exposure, 24h exposure, inhalation). In the absence of data, it is assumed that 50% absorption occurs by oral route. To secure a conservative NOAEL a maximum absorption (i.e. 100%) is assumed for the inhalation route. The rat Standard Respiratory Volume (SRV) for 24 h exposure is used to convert the oral NOAEL into an inhalatory NOAEL (sRVrat: 1.15 m3/kg bw/24h). The corrected starting point is thus calculated as follows: corrected inhalatory NOAEC = oral NOAEL x (1/sRVrat) x (absorption oral rat/absorption inhalation human); thus corrected inhalation NOAEL for general population = 180.2 mg/kg bw/d x 0.5 x (1/1.15 m3/kg bw/d) = 78 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for oral to inhalation route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differencies
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 180.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dose descriptor is available for dermal route. However, no additional factor is needed when performing oral to dermal extrapolation
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differencies
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
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:
- 0.3 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 180.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route-to-route extrapolation needed
- AF for dose response relationship:
- 1
- Justification:
- Starting point is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Toxicodynamic and toxicokinetic remaining differencies
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Appropriate database
- AF for remaining uncertainties:
- 1
- Justification:
- None
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - 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.
