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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.98 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA TGD R.8 using the SECO DNEL Tool v. 1.0
Overall assessment factor (AF):
13.75
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
123.42 mg/m³
Explanation for the modification of the dose descriptor starting point:

Bioavailability: 50% oral bioavailability (default) and 100% inhalation bioavailability (default)

Standard respiratory volume:, animal (sRVan): 0.38 m³/kg bw/8h; Standard respiratory volume, human (sRVhu): 6.7 m³/person; Worker respiratory volume (wRV): 10 m³/person; Differences experimental/human exposure conditions: 1.4.

Calculation starting point:

Experimental exposure: 7 days/week; Worker exposure: 5 days/week; Starting point = 100 mg/kg bw/d * 7/5

AF for dose response relationship:
0.55
Justification:
As the test item CXN1-55 is manufactured and handled only as aqueous solution with about 55% concentration, an additional factor of 0.55 is used to derive a DNEL for exposure to the aqueous solution.
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Included in calculation starting point
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Differences within worker population.
AF for the quality of the whole database:
1
Justification:
Reliable studies used
AF for remaining uncertainties:
1
Justification:
No remaining differences
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:
2.55 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA TGD R.8 using the SECO DNEL Tool v. 1.0
Overall assessment factor (AF):
55
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
140 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral and dermal uptake are considered to be identical.

Calculation of starting point:

Experimental exposure: 7 days/week

Worker exposure: 5 days/week

Starting point = 100 mg/kg bw/d * 7/5 = 140 mg/kg bw/d (human, dermal)

AF for dose response relationship:
0.55
Justification:
As the test item CXN1-55 is manufactured and handled only as aqueous solution with about 55% concentration, an additional factor of 0.55 is used to derive a DNEL for exposure to the aqueous solution.
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
Differences within worker population
AF for the quality of the whole database:
1
Justification:
Reliable studies used
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:
no hazard identified
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

The acute/short-term inhalation DNELs for systemic and local effects were not derived, since the substance is non volatile with a melting point > 300 °C and no generation of aerosol is expected.

The acute/short term exposure dermal DNEL for systemic effects was not derived, since no hazard was identified for Reaction mass of CXN1-55 for dermal toxicity. In the acute dermal toxicity study the LD50 was found to be > 2000 mg/kg bw.

The long-term dermal DNEL for local effects was not derived, since no hazard was identified for Reaction mass of CXN1-55. The substance is not skin sensitizer and not skin irritant in the respective studies.

The short-term dermal DNEL for local effects was not derived, since no hazard was identified for Reaction mass of CXN1-55. The substance is not skin irritating in the respective study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.58 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA TGD R.8 using the SECO DNEL Tool v. 1.0
Overall assessment factor (AF):
27.5
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
43.5 mg/m³
Explanation for the modification of the dose descriptor starting point:

Bioavailability: 50% oral bioavailability (default) and 100% inhalation bioavailability (default)

For the general population (24h exposure/day), the corrected inhalatory NOAEC = oral NOAEC * 1/sRVrat * ABSoral-rat /ABSinhal-human

 

           = 100 mg/kg bw/day * 1/1.15 m3/kg * ABSoral-rat /ABSinhal-human

 

           = 100 mg/kg bw/day * 1/1.15 m3/kg * 0.5 = 43.48 mg/m3

 

With ABS: Absorption, sRV: Standard Respiratory Volume; ABSoral-rat /ABSinhal-human= 50/100= 0.5.

AF for dose response relationship:
0.55
Justification:
As the test item CXN1-55 is manufactured and handled only as aqueous solution with about 55% concentration, an additional factor of 0.55 is used to derive a DNEL for exposure to the aqueous solution.
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No correction for caloric demand for inhalation, this is included in dose descriptor starting point
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
Differences within general population.
AF for the quality of the whole database:
1
Justification:
Reliable studies used
AF for remaining uncertainties:
1
Justification:
No rmaining differences
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:
DNEL (Derived No Effect Level)
Value:
0.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA TGD R.8 using the SECO DNEL Tool v. 1.0
Overall assessment factor (AF):
110
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Oral and dermal uptake are considered to be identical.

AF for dose response relationship:
0.55
Justification:
As the test item CXN1-55 is manufactured and handled only as aqueous solution with about 55% concentration, an additional factor of 0.55 is used to derive a DNEL for exposure to the aqueous solution.
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
Differnces within general population
AF for the quality of the whole database:
1
Justification:
Reliable studies used
AF for remaining uncertainties:
1
Justification:
No remaining differences
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
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:
0.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA TGD R.8 using the SECO DNEL Tool v. 1.0
Overall assessment factor (AF):
110
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
0.55
Justification:
As the test item CXN1-55 is manufactured and handled only as aqueous solution with about 55% concentration, an additional factor of 0.55 is used to derive a DNEL for exposure to the aqueous solution.
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
Differences within general population
AF for the quality of the whole database:
1
Justification:
Reliable studies used
AF for remaining uncertainties:
1
Justification:
No remaining differences
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:
low hazard (no threshold derived)

Additional information - General Population

The acute/short-term inhalation DNELs for systemic and local effects were not derived, since the substance is non volatile with a melting point > 300 °C and no generation of aerosol is expected.

The acute/short term exposure dermal DNEL for systemic effects was not derived, since no hazard was identified for Reaction mass of CXN1-55 for dermal toxicity. In the acute dermal toxicity study the LD50 was ound to exceed 2000 mg/kg bw.

The long-term dermal DNEL for local effects was not derived, since no hazard was identified for Reaction mass of CXN1-55. The substance is not skin sensitizer and not skin irritant in the respective studies.

The short-term dermal DNEL for local effects was not derived, since no hazard was identified for Reaction mass of CXN1-55. The substance is not skin irritating in the respective study.

The acute/short term exposure oral DNEL for systemic effects was not derived, since no hazard was identified for Reaction mass of CXN1-55 for oral toxicity. In the acute oral toxicity study the LD50 was found to be > 2000 mg/kg bw.