Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.76 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:
132.24 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 150 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(1/2)*0.67 = 132.24 mg/m³. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans. 200% absorption is assumed for the inhalation route compared to the oral route in both species.
AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on a 28-day study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
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:
no hazard identified
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.5 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:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (150 mg/kg bw/day)*(1/1) = 150 mg/kg bw/day. It is assumed that the dermal absorption rate is 100% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on a 28-day study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
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:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

DNELs were derived in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8 (ECHA, 2012).

EC 424-820-7 shows lack of systemic toxicity in an EU method B.3/OECD 402 acute dermal toxicity study (LD50 >500 mg/kg), the majority of toxicity seen within this study is irritation to the skin caused by the corrosive nature of the material. EC 424-820-7 is therefore considered no hazard systemically through acute/short term dermal exposure.

EC 424-820-7 shows limited systemic toxicity in an EU Method B.1 acute oral toxicity study (LD50 >2000 mg/kg), the majority of toxicity seen within this study is local irritation to the forestomach caused by the corrosive nature of the material. EC 424-820-7 is therefore considered no hazard systemically in relation to acute/short term oral exposure.

EC 424-820-7 is considered a medium hazard for local dermal effects after long term and acute exposure due to its corrosive nature to both the skin and eyes. However, this is a precautionary statement as probably there is no activity if exposure remains below the irritancy threshold. No further investigation is deemed necessary due to a demonstrated lack of exposure.

The long term DNEL for systemic effects via the inhalation and dermal route has been derived using the 28 day repeat dose oral study conducted on the registration material. A NOAEL of 150 mg/kg/day (top dose tested) was generated for systemic toxicity based on no significant toxicological effects observed in the study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.43 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:
65.22 mg/m³
Explanation for the modification of the dose descriptor starting point:
NOAECcorr = NOAELoral*(1/1.15 m³/kg bw/day)*(ABSoral-rat/ABSinh-human) = 150 mg/kg bw/day*(1/1.15 m³/kg bw/day)*(1/2) =65.22 mg/m³. It is assumed that oral absorption rate is 200% of that of inhalation absorption. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on a 28-day study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties
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:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.25 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:
150 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
NOAELcorr = NOAELoral*(ABSoral-rat/ABSdermal-human) = (150 mg/kg bw/day)*(1/1) = 150 mg/kg bw/day. It is assumed that the dermal absorption rate is 100% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
AF for dose response relationship:
1
Justification:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on a 28-day study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
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:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
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:
0.25 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:
150 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:
DNEL is based on a NOAEL
AF for differences in duration of exposure:
6
Justification:
DNEL is based on a 28-day study
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
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:
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:
medium hazard (no threshold derived)

Additional information - General Population

DNELs were derived in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8.

EC 424-820-7 shows lack of systemic toxicity in an EU method B.3/OECD 402 acute dermal toxicity study (LD50 >500 mg/kg), the majority of toxicity seen within this study is irritation to the skin caused by the corrosive nature of the material. EC 424-820-7 is therefore considered a low hazard systemically through acute/short term exposure.

EC 424-820-7 shows limited systemic toxicity in an EU Method B.1 acute oral toxicity study (LD50 >2000 mg/kg), the majority of toxicity seen within this study is local irritation to the forestomach caused by the corrosive nature of the material. EC 424-820-7 is therefore considered a low hazard systemically in relation to acute/short term oral exposure.

EC 424-820-7 is considered a medium hazard for local effects (both long term and acute) due to its corrosive nature to both the skin and eyes (H314, category 1C).

The long term DNEL for systemic effects via the oral, dermal and inhalation route has been derived using the 28 day repeat dose oral study conducted on the registration material. A NOAEL of 150 mg/kg/day (top dose tested) was generated for systemic toxicity based on no significant toxicological effects observed in the study.