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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
122 µg/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:
NOAEC
Value:
18.2 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
9.15 mg/m³
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an inhalatory NOAEC observed in a subacute inhalation study (OECD 412, 1998). The NOAEC is corrected to account for differences between experimental and human exposure conditions. It is further corrected for the difference between respiratory rates under standard conditions and under conditions of light activity (sRVhuman versus wRV).

 

NOAECcorr = NOAEC*(6 h per day/8 h per day)*(6.7 m³ (8 h)/10 m³ (8 h))

NOAECcorr = 18.2 mg/m³ * 0.75 * 0.67 = 9.15 mg/m³

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEC.
AF for differences in duration of exposure:
6
Justification:
The DNEL is based on a 28-day inhalation study with rats (exposed 6 h/day).
AF for interspecies differences (allometric scaling):
1
Justification:
Interspecies differences were taken into account for the conversion of the rat NOAEC into a modified human NOAEC considering allometric scaling for the respiratory volumes (modification of the dose descriptor starting point). Thus, no additional AF is applicable.
AF for other interspecies differences:
2.5
Justification:
Default AF according to ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
Default AF for workers according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
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:
222 µg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor starting point:
NOAEL
Value:
2 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an oral NOAEL observed in a prenatal developmental toxicity study in rabbits (key, 1996). To convert the rabbit oral NOAEL into a corrected dermal NOAEL to assess human dermal exposure, the NOAEL has to be corrected as follows:

NOAELdermal = NOAELoral * (ABSoral-rabbit/ABSderm-human)

NOAELdermal = 2 mg/kg bw/day * (100/10) = 20 mg/kg bw/day

 

ABS = absorption

Dermal absorption is considered to be 1% when handling concentrated test substance or 10% when diluted (Thiacloprid 2004: Sanco/4347/2000). Oral absorption was considered to be 100%. Therefore, a factor of 10 was included for oral to dermal extrapolation, as a worst case approach. 

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
1
Justification:
The DNEL is based on a prenatal developmental toxicity study; therefore, the relevant period is covered.
AF for interspecies differences (allometric scaling):
2.4
Justification:
Default AF for rabbits according to ECHA REACH Guidance.
AF for other interspecies differences:
2.5
Justification:
Default AF according to ECHA REACH Guidance.
AF for intraspecies differences:
5
Justification:
Default AF for workers according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study.
AF for remaining uncertainties:
3
Justification:
AF of 3 was used to reflect that even a single dose might be sufficient to cause adverse developmental effects in the offspring of pregnant females.
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
Most sensitive endpoint:
repeated dose toxicity
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:
21.7 µg/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:
NOAEC
Value:
18.2 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
3.25 mg/m³
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an inhalatory NOAEC observed in a subacute inhalation study (OECD 412, 1998). The NOAEC is corrected to account for differences between experimental conditions (6 h/day) and general population exposure conditions (24 h/day), as well as differences in experimental exposure frequency (5 days/week) and general population exposure frequency (7 days/week).

 

NOAECcorr = NOAEC*(6/24)*(5/7)

NOAECcorr = 18.2 mg/m³ * 0.25 * 0.71 = 3.25 mg/m³

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEC.
AF for differences in duration of exposure:
6
Justification:
The DNEL is based on a subacute inhalation study.
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in ECHA starting point derivation method; no further factor required.
AF for other interspecies differences:
2.5
Justification:
Default AF according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default AF for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
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:
111 µg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor starting point:
NOAEL
Value:
2 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an oral NOAEL observed in a prenatal developmental toxicity study in rabbits (key, 1996). To convert the rabbit oral NOAEL into a corrected dermal NOAEL to assess human dermal exposure, the NOAEL has to be corrected as follows:

NOAELdermal = NOAELoral * (ABSoral-rabbit/ABSderm-human)

NOAELdermal = 2 mg/kg bw/day * (100/10) = 20 mg/kg bw/day

 

ABS = absorption.

Dermal absorption is considered to be 1% when handling concentrated test substance or 10% when diluted (Thiacloprid 2004: Sanco/4347/2000). Oral absorption was considered to be 100%. Therefore, a factor of 10 was included for oral to dermal extrapolation, as a worst case approach. 

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
1
Justification:
The DNEL is based on a prenatal developmental toxicity study; therefore, the relevant period is covered.
AF for interspecies differences (allometric scaling):
2.4
Justification:
Default AF for rabbits according to ECHA REACH Guidance.
AF for other interspecies differences:
2.5
Justification:
Default AF according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default AF for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
The DNEL is based on a high-quality study.
AF for remaining uncertainties:
3
Justification:
AF of 3 was used to reflect that even a single dose might be sufficient to cause adverse developmental effects in the offspring of pregnant females.
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
Most sensitive endpoint:
repeated dose toxicity
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:
11.1 µg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
180
Dose descriptor starting point:
NOAEL
Value:
2 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification of the starting point needed.

AF for dose response relationship:
1
Justification:
The dose descriptor starting point is based on a NOAEL.
AF for differences in duration of exposure:
1
Justification:
DNEL is based on a prenatal developmental toxicity study; therefore, the relevant period is covered..
AF for interspecies differences (allometric scaling):
2.4
Justification:
Default AF for rabbits according to ECHA REACH Guidance.
AF for other interspecies differences:
2.5
Justification:
Default AF according to ECHA REACH Guidance.
AF for intraspecies differences:
10
Justification:
Default AF for general population according to ECHA REACH Guidance.
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study.
AF for remaining uncertainties:
3
Justification:
AF of 3 was used to reflect that even a single dose might be sufficient to cause adverse developmental effects in the offspring of pregnant females.
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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