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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 288-312-5 | CAS number: 85711-52-0
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.75 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
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
NOAEC worker = NOAEL x ( sRV human,8h/sRV human worker, 8h)/ sRV rat 8h= 0.5*1000/(6.7/10*0.38)=881.5 mg/m3
oral abs/inhalation abs= 0.5 (i.e. 50% absorption in oral external dose corresponds to 100% absorption in inhalative external dose), AF =2
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- value for subacute test (28d) to extrapolate to chronic exposure (ECETOC TRA)
- Justification:
- allometric scaling for rats (considered in the 0.38 m3/kg (8h), the srVrat (8h))
- AF for other interspecies differences:
- 2.5
- Justification:
- contribution for other effetcs not modeled by metabolic rate (ECETOC TRA)
- AF for intraspecies differences:
- 3.35
- Justification:
- default contribution for variability in the worker population (ECETOC TRA) = 5
correction for srV human (8h)/srV human (8h) worker = 6.7/10 = 0.67
total AF= 3.35 - AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 33.3 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):
- 30
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- other: oral absorption/dermal absorption = 10
- Explanation for the modification of the dose descriptor starting point:
Based on the phys-chem properties of the substance, the dermal uptake of the most representative constituent (diammides from DETA and C18) was calculated with following equations:
log Kp = -2.80 + 0.66 log Kow -0.0056 MW
and
dermal uptake (mg) = Kp(cm/hr)*conc (mg/cc)*contact time (hr)*contact area (cm2) from Paustenbach (2000).
where
logKow= 5.99
MW = 608 g/mol
water concentration = 0.071 mg/l
contact area = 3 cm2
contact time = 4h
event/ day = 1
dermal uptake = 0.0071 mg.
If human body weight = 70 kg,
dermal uptake = 1 x 10-4 mg/kg/event
therefore by dermal exposure the absorption of the substance is very limited and for assessment purposes the ratio betwenn oral and dermal absorption is considered equal to 10, i.e.:
ABSoral/ABSdermal = 10, or AF=0.1
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- see justification above
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- see justification above
- AF for other interspecies differences:
- 2.5
- Justification:
- see justification above
- AF for intraspecies differences:
- 5
- Justification:
- see justification above
- AF for the quality of the whole database:
- 1
- Justification:
- see justification above
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEC
- Explanation for the modification of the dose descriptor starting point:
NOAEC general population = NOAEC worker/sRV rat, 24h= 869.5 mg/m3 *0.5 =434.75 mg/m3
ABS oral/ABSinhal= 0.5 (i.e. 100% absorption in oral external dose corresponds to 100% absorption in inhalative external dose), AF= 2
- AF for dose response relationship:
- 1
- Justification:
- see justification in the worker section
- AF for differences in duration of exposure:
- 6
- Justification:
- see justification in the worker section
- Justification:
- allometric scaling for rats (considered in the 1.15 m3/kg (24h), the srVrat (24h))
- AF for other interspecies differences:
- 2.5
- Justification:
- see justification in the worker section
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population variability that includes consumers and man via the environment (ECETOC TRA)
- AF for the quality of the whole database:
- 1
- Justification:
- see justification in the worker section
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16.67 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):
- 60
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- other: oral absorption/dermal absorption = 10
- Value:
- 16.67 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the phys-chem properties of the substance, the dermal uptake of the most representative constituent (diammides from DETA and C18) was calculated with following equations:
log Kp = -2.80 + 0.66 log Kow -0.0056 MW
and
dermal uptake (mg) = Kp(cm/hr)*conc (mg/cc)*contact time (hr)*contact area (cm2) from Paustenbach (2000).
where
logKow= 5.99
MW = 608 g/mol
concentration (mg/cm3) = 1% of the water solubility = 7.1x 10-4 mg/cm2
contact area = total body surface are= 19000 cm2
contact time = 8h
dermal uptake = 4.5 mg.
If human body weight = 70 kg,
dermal uptake = 0.064 mg/kg/event
therefore by dermal exposure the absorption of the substance is very limited and for assessment purposes the ratio betwenn oral and dermal absorption is considered equal to 10, i.e.:
ABSoral/ABSdermal = 10, or AF=0.1
- AF for dose response relationship:
- 1
- Justification:
- see justification in the worker section
- AF for differences in duration of exposure:
- 6
- Justification:
- see justification in the worker section
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- see justification in the worker section
- AF for other interspecies differences:
- 2.5
- Justification:
- see justification in the worker section
- AF for intraspecies differences:
- 10
- Justification:
- default value for the variability in the general population including consumers and man via the environment
- AF for the quality of the whole database:
- 1
- Justification:
- see justification in the worker section
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 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
- Dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
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.
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