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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
17 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:
other: NOEL
Value:
347 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEC
Value:
425 mg/m³
Explanation for the modification of the dose descriptor starting point:

No long-term exposure data is available for the inhalation route therefore the NOEL resulted from an animal study were the analogue substance was given in feed for 90 days is used.

Route-to-route extrapolation is therefore needed from the oral to the inhalation route.

The NOEL rat is converted to NOEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOEL human with the default human body weight (70 kg) and dividing the default human breathing volume referring to workers (10 m3 in 8h and light activity), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for the substance.

NOELoral= 347 mg/kg b.w

Standard human body weight = 70 kg

Default human breathing volume for workers in 8 hours = 10 m3

Due to the difference between human (workers) and experimental exposure conditions, a correction factor of 1.4 is applied. Furthermore, a correction factor of 0.5 is used due to differences in bioavailability.

Therefore, NOECinh= (347/4)* (70/10)* (1.4*0.5) = 425 mg/m3

AF for dose response relationship:
1
Justification:
The starting point for the DNEL derivation is a NOEL; default factor is 1
AF for differences in duration of exposure:
2
Justification:
The duration of the animal study is 90 days. Extrapolation needed from subchronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scalling is already taken into consideration during the route-to-route extrapolation.
AF for other interspecies differences:
2.5
Justification:
Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
AF for intraspecies differences:
5
Justification:
Default factor for workers is applied.
AF for the quality of the whole database:
1
Justification:
Good/standard quality of database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.86 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:
other: NOEL
Value:
347 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
485.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No long-term exposure data is available for the dermal route for the substance therefore the NOEL resulted from an animal study where the similar substance was orally administered for 90 days to rats is used. No route-to-route extrapolation is needed. It is assumed that dermal absorption will not be higher than oral absorption; default factor is 1.

Due to the difference between human (workers) and experimental exposure conditions, a correction factor of 1.4 is applied.

Therefore, the NOEL = 347 mg/kg bw/day * 1.4 = 485.8 mg/m3

AF for dose response relationship:
1
Justification:
NOEL was used; default AF is 1.
AF for differences in duration of exposure:
2
Justification:
Adjustment from sub-chronic to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
Extrapolation from rats to humans
AF for other interspecies differences:
2.5
Justification:
No substance-specific data are available; the additional factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate - small part- and toxicodynamic differences - larger part).
AF for intraspecies differences:
5
Justification:
Default factor for workers is applied.
AF for the quality of the whole database:
1
Justification:
Good/standard quality of database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
skin irritation/corrosion

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:
6.08 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):
50
Dose descriptor starting point:
other: NOEL
Value:
347 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEC
Value:
304 mg/m³
Explanation for the modification of the dose descriptor starting point:

No long-term exposure data are available for the inhalation route therefore the NOAEL resulted from an animal study were the analogue substance was given in feed to rats for 90 days is used.

Route-to-route extrapolation is therefore needed from the oral to the inhalation route.

The NOEL rat is converted to NOEL human by dividing with the allometric scalling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing by the default human breathing volume referring to general public (20 m3 in 24 hours and basal caloric demand), this dose is then translated into an air concentration. The absorption rate for human via inhalation is not known for the substance. It is assumed that absorption rate via inhalation route is similar to absorption rate via oral route.

NOELoral = 347 mg/kg b.w

Standard human body weight = 70 kg

Default human breathing volume for general pobulation in 24 hours = 20 m3

Allometric scalling factor for rats as compared to humans = 4

Therefore, NOAECinh= (347/4)* (70/20) = 304 mg/m3

AF for dose response relationship:
1
Justification:
The starting point for the DNEL derivation is a NOEL; default factor AF=1 is used.
AF for differences in duration of exposure:
2
Justification:
The duration of the animal study is 90 days. Extrapolation needed from subchronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scalling is already taken into consideration during the route-to-route extrapolation.
AF for other interspecies differences:
2.5
Justification:
Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
AF for intraspecies differences:
10
Justification:
Default factor for general population is applied.
AF for the quality of the whole database:
1
Justification:
Good/standard quality of database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
1.74 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:
other: NOEL
Value:
347 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No long-term exposure data is available for the dermal route for the substance therefore the NOEL resulted from an animal study where the similar substance was administered in the feed to rats for 90 days is used. No route-to-route extrapolation is needed. It is assumed that dermal absorption will not be higher than oral absorption; default factor is 1

AF for dose response relationship:
1
Justification:
NOEL was used; default AF is 1.
AF for differences in duration of exposure:
2
Justification:
Extrapolation for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
No adjustment for direct chemical reactivity with membrane
AF for other interspecies differences:
2.5
Justification:
No adjustment for direct chemical reactivity with membrane
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Good/standard quality of database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.74 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:
other: NOEL
Value:
347 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOEL resulted from an animal study where rats were given the analogue substance in feed for 90 days is used for the DNEL determination.

AF for dose response relationship:
1
Justification:
The starting point for the DNEL derivation is a NOEL; default factor AF=1 is used.
AF for differences in duration of exposure:
2
Justification:
Extrapolation for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scalling from rat to humans
AF for other interspecies differences:
2.5
Justification:
Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
AF for intraspecies differences:
10
Justification:
Default factor for general population is applied.
AF for the quality of the whole database:
1
Justification:
Good/standard quality of database.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population