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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.2 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:
88.16 mg/m³
Explanation for the modification of the dose descriptor starting point:
There is no reliable inhalation toxicity study available. In fact, the test cannot be conducted since the target substance has low evaporation rate from aqueous solution.
AF for dose response relationship:
1
Justification:
default AF
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
AF for workers
AF for the quality of the whole database:
1
Justification:
default AF
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
16.7 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:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study has been conducted since the substance does not penetrate the skin.
AF for dose response relationship:
1
Justification:
default AF
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat-human
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
default AF
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
medium hazard (no threshold derived)

Additional information - workers

Long-term - systemic - inhalation

The NOAEL for F0 systemic effects is derived from the oral repeated toxicity/dev.toxicity study (OECD 422) in rats (Baracani, R. 2015).

Relevant dose descriptor

NOAEL = 50 mg/kg/day, subacute, oral exposure, rats

Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 3.

100 % oral absorption for rats

100 % inhalation absorption regardless of species

 

Corrected inhalatory NOAEC = oral NOAEL * (1/ sRVrat 8h) * (ABSoral-rat/ ABSinh-human) * (sRVhuman 8h/ wRV)

ABS – absorption

sRVrat 8h – respiratory volume under standard conditions (8h)

sRVhuman 8h- respiratory volume under standard conditions (8h)

wRV - respiratory volume light activity for worker

 

Corrected inhalatory NOAEC= 50 * (1/0.38) * (100/100) * (6.7 / 10)

Corrected inhalatory NOAEC = 88,16 mg/m3

Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health

Interspecies - remaining differences 2.5

Intraspecies differences for workers 5

Exposure duration - subacute to chronic 6

Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEC - default assessment factor 1

Quality of whole database - default assessment factor 1

 

Overall AF 2.5 * 5 * 6 * 1 * 1 = 75       

 

DNEL worker inhalation= 88.16 mg/m3/ 75 = 1.2 mg/m3

Long-term - systemic - dermal

The NOAEL for F0 systemic effects is derived from the oral repeated toxicity/dev.toxicity study (OECD 422) in rats (Baracani, R. 2015).

Relevant dose descriptor

NOAEL = 50 mg/kg/day, subacute, oral exposure, rats

Modification of the dose descriptor according to ECHA Guidance R.8 (November 2012) Example B. 5.

100 % oral absorption for rats

1 % dermal absorption regardless of species -> Active chlorine species will not pass the skin.

 

Corrected dermal NOAEL = oral NOAEL * (ABSoral-rat/ ABSderm-human)

ABS – absorption

Corrected dermal NOAEL= 50 * (100/1)

Corrected dermal NOAEL = 5000 mg/kg bw/day

Assessment factors according to ECHA 2012 Guidance R.8 Characterization of dose response to human health

Allometric scaling; rat-human 4

Interspecies - remaining differences 2.5

Intraspecies differences for workers 5

Exposure duration - subacute to chronic 6

Issues related to dose responses - the starting point for the DNEL calculation is a derived NOAEL - default assessment factor 1

Quality of whole database - default assessment factor 1

 

Overall AF 4 * 2.5 * 5 * 6 * 1 * 1 = 300       

 

DNEL worker dermal = 5000 mg/kg bw/day / 300 = 16.7 mg/kg bw/day

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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