Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.7 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:
NOAEL
DNEL value:
275 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
242 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL of 275 mg/kg bw/d from the 90-day oral rat study is corrected for activity (*6.7/10), breathing rate (*1.0/0.38) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 242 mg/m3. 

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Extrapolation from a subchronic study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not required; already accounted for in correction of the endpoint
AF for other interspecies differences:
2.5
Justification:
Standard factor
AF for intraspecies differences:
5
Justification:
Standard factor (workers)
AF for the quality of the whole database:
1
Justification:
Standard factor; good quality database
AF for remaining uncertainties:
1
Justification:
No significant remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.8 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:
NOAEL
DNEL value:
275 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
275 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption.

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Extrapolation from a sub-chronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
The starting point is derived from a study in the rat
AF for other interspecies differences:
2.5
Justification:
Standard factor
AF for intraspecies differences:
5
Justification:
Standard factor (workers)
AF for the quality of the whole database:
1
Justification:
Standard factor: high quality database
AF for remaining uncertainties:
1
Justification:
Standard factor: no significant uncertainties remaining.
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

The starting point for DNEL derivation is the NOAEL of 275 mg/kg bw/d from the 90 -day rat study.

 

Inhalation DNELs

For the long-term inhalation DNEL, the NOAEL of 275 mg/kg bw/d from the 90-day oral rat study is corrected for activity (*6.7/10), breathing rate (*1.0/0.38) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 242 mg/m3.

CTF is a mild eye irritant and is classified for eye irritation. The substance may therefore cause mild respiratory irritation; however significant effects are unlikely at exposure levels below the systemic inhalation DNEL.

 

Dermal DNELs

In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption. The corrected starting point for the long-term dermal DNEL is therefore a NOAEL of 275 mg/kg bw/d. CTF is not classified for skin irritation or skin sensitisation. In the absence of any hazard, derivation of a local dermal DNEL value is not required.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.4 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:
NOAEL
DNEL value:
275 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
120 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL of 275 mg/kg bw/d from the 90-day oral rat study is corrected for breathing rate (*1.0/1.15) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 120 mg/m3.

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL
AF for differences in duration of exposure:
2
Justification:
Extrapolation from a sub-chronic study to chronic exposure
AF for interspecies differences (allometric scaling):
1
Justification:
Not required; already accounted for in correction of the starting point
AF for other interspecies differences:
2.5
Justification:
Standard factor
AF for intraspecies differences:
10
Justification:
Standard factor (general population)
AF for the quality of the whole database:
1
Justification:
Standard factor; good quality database
AF for remaining uncertainties:
1
Justification:
Standard factor; no significant uncertainties remaining
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 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:
NOAEL
DNEL value:
275 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
275 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point is the NOAEL of 275 mg/kg bw/d from the 90 -day oral rat study. In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption. The corrected starting point is therefore a NOAEL of 275 mg/kg bw/d. 

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
Extrapolation from a sub-chronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor: starting point is derived from a study in the rat
AF for other interspecies differences:
2.5
Justification:
Standard factor
AF for intraspecies differences:
10
Justification:
Standard factor: general population
AF for the quality of the whole database:
1
Justification:
Standard factor: high quality database
AF for remaining uncertainties:
1
Justification:
Standard factor: no significant uncertainties remaining
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:
DNEL (Derived No Effect Level)
Value:
1.4 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:
NOAEL
DNEL value:
275 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Modification of the starting point is not required.

AF for dose response relationship:
1
Justification:
The starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
Extrapolation from a sub-chronic study to chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
Standard factor: strarting point is from a study in the rat
AF for other interspecies differences:
2.5
Justification:
Standard factor
AF for intraspecies differences:
10
Justification:
Standard factor (general population)
AF for the quality of the whole database:
1
Justification:
Standard factor: good quality database
AF for remaining uncertainties:
1
Justification:
Standard factor: no significant uncertainties remaining
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

The starting point for DNEL derivation is the NOAEL of 275 mg/kg bw/d from the 90 -day rat study.

 

Inhalation DNELs

For the long-term inhalation DNEL, the NOAEL of 275 mg/kg bw/d from the 90-day oral rat study is corrected forbreathing rate (*1.0/1.45) and relative absorption (*1/2) to derive a corrected inhalation NOAEC of 120 mg/m3.

CTF is a mild eye irritant and is classified for eye irritation. The substance may therefore cause mild respiratory irritation; however significant effects are unlikely at exposure levels below the systemic inhalation DNEL.

 

Dermal DNELs

In the absence of dermal absorption data, dermal absorption is considered to be equivalent to oral absorption. The corrected starting point for the long-term dermal DNEL is therefore a NOAEL of 275 mg/kg bw/d. CTF is not classified for skin irritation or skin sensitisation. In the absence of any hazard, derivation of a local dermal DNEL value is not required.