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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
LOAEC
Value:
100 mg/m³
Modified dose descriptor starting point:
LOAEC
Value:
50.25 mg/m³
Explanation for the modification of the dose descriptor starting point:
LOAEC instead of a NOAEC is chosen as a dose descriptor starting point. Rationale: (1) large spacing, factor 20, between LOAEC (100 mg/m3) and NOAEC (5.3 mg/m3) (2) the nature and incidence of the observed effects at the LOAEC. Corrected LOAEC = inhalatory LOAEC * 6 h/d / 8 h/d * 6.7 m3 (8h) / 10 m3 (8h) = inhalatory LOAEC * 0.503 = 50.25 mg/m3
AF for dose response relationship:
3
Justification:
AF for the use of a LOAEC instead of a NOAEC as dose descriptor starting point.
AF for differences in duration of exposure:
2
Justification:
AF for subchronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Not used for inhalation route.
AF for other interspecies differences:
2.5
Justification:
AF for potential remaining differences.
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences for workers.
AF for the quality of the whole database:
1
Justification:
read-across to formulation with DBPP (Skydrol 500B-4) but this formulation is expected to be more harmful, as the levels of TBP are higher.
AF for remaining uncertainties:
1
Justification:
No additional uncertainties identified.
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:
0.67 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor:
other: Modified dose descriptor (LOAEL) consistent to the systemic route.
Value:
50.25 mg/m³
AF for dose response relationship:
3
Justification:
AF for the use of a LOAEC instead of a NOAEC as dose descriptor starting point.
AF for differences in duration of exposure:
2
Justification:
AF for subchronic to chronic.
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
Justification:
AF for potential remaining differences.
AF for intraspecies differences:
5
Justification:
AF for intraspecies differences for workers
AF for the quality of the whole database:
1
Justification:
No additional AF required.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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:
1.39 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
720
Dose descriptor starting point:
LOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The LOAEL instead of NOAEL is used as starting dose descriptor due to the tenfold difference between the NOAEL (100 mg/kg bw) and LOAEL (1000 mg/kg bw). The only observed systemic effect at the LOAEL was a decreased choline esterase activity.
AF for dose response relationship:
3
Justification:
Default AF for use of LOAEL.
AF for differences in duration of exposure:
8
Justification:
21-day study (15 days of treatment); AF for subacute * 28/21 = 8
AF for interspecies differences (allometric scaling):
2.4
Justification:
AF for allometric scaling from rabbit.
AF for other interspecies differences:
2.5
Justification:
AF for remaining differences.
AF for intraspecies differences:
5
Justification:
Default assessment factor for workers.
AF for the quality of the whole database:
1
Justification:
No additional AF required.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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:
0.48 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
Value:
2.37 mg/m³
AF for dose response relationship:
1
Justification:
NOAEL (mg/cm2)
AF for differences in duration of exposure:
1
Justification:
13 applications, each exposure: 24 h, resting period between applications: 24 h
AF for interspecies differences (allometric scaling):
1
Justification:
No AF for dermal irritation/corrosion
AF for other interspecies differences:
1
Justification:
No AF for dermal irritation/corrosion
AF for intraspecies differences:
5
Justification:
AF for workers
AF for the quality of the whole database:
1
Justification:
No additional AF required.
AF for remaining uncertainties:
1
Justification:
No additional uncertainty
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
0.167 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
LOAEC
Value:
100 mg/m³
Modified dose descriptor starting point:
LOAEC
Value:
25 mg/m³
Explanation for the modification of the dose descriptor starting point:
LOAEC instead of a NOAEC is chosen as a dose descriptor starting point. Rationale: (1) large spacing, factor 20, between LOAEC (100 mg/m3) and NOAEC (5.3 mg/m3) (2) the nature and incidence of the observed effects at the LOAEC. Corrected LOAEC = inhalatory LOAEC * (6 h/d / 24 h/d) = inhalatory LOAEC * 0.25 = 25 mg/m3
AF for dose response relationship:
3
Justification:
LOAEC instead of NOAEC is used as dose descriptor starting point
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no AF used for inhalation
AF for other interspecies differences:
2.5
Justification:
AF for remaining differences
AF for intraspecies differences:
10
Justification:
default AF for the general population
AF for the quality of the whole database:
1
Justification:
read-across to formulation with DBPP (Skydrol 500B-4) but this formulation is expected to me more harmful, as it contains higher TBP levels
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.167 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
LOAEC
AF for dose response relationship:
3
Justification:
LOAEC instead of NOAEC is used as dose descriptor starting point
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
no AF used for inhalation
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
default factor for general population
AF for the quality of the whole database:
1
Justification:
read-across to formulation with DBPP (Skydrol 500B-4) but this formulation is expected to me more harmful
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
DNEL (Derived No Effect Level)
Value:
0.69 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 440
Dose descriptor starting point:
LOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
LOAEL instead of NOAEL is used as starting dose descriptor due to the tenfold difference between the NOAEL (100 mg/kg bw) and LOAEL (1000 mg/kg bw). The only observed systemic effect at the LOAEL was a decreased choline esterase activity.
AF for dose response relationship:
3
Justification:
default AF for LOAEL
AF for differences in duration of exposure:
8
Justification:
21-day study (15 days of treatment); AF for subacute * 28/21 = 8
AF for interspecies differences (allometric scaling):
2.4
Justification:
AF for allometric scaling from rabbit
AF for other interspecies differences:
2.5
Justification:
AF for remaining differences
AF for intraspecies differences:
10
Justification:
AF for general population
AF for the quality of the whole database:
1
Justification:
No additional AF required.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
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:
0.24 mg/cm²
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
Value:
2.27 mg/m³
AF for dose response relationship:
1
Justification:
NOAEL (mg/m2)
AF for differences in duration of exposure:
1
Justification:
13 applications, each exposure: 24h, resting period between applications: 24h
AF for interspecies differences (allometric scaling):
1
Justification:
No AF for dermal irritation/corrosion
AF for other interspecies differences:
1
Justification:
No AF for dermal irritation/corrosion
AF for intraspecies differences:
10
Justification:
AF for general population
AF for the quality of the whole database:
1
Justification:
No AF required
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.025 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):
200
Dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL is used as dose descriptor starting point
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
AF for allometric scaling from rat
AF for other interspecies differences:
2.5
Justification:
AF for remaining differences
AF for intraspecies differences:
10
Justification:
AF for general population
AF for the quality of the whole database:
1
Justification:
No AF required
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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