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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.33 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
7 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
There are no inhalation studies for this substance and the extrapolation of oral studies to other routes is the only method available.
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 120 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
Value:
112 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
There are no inhalation studies for this substance and the extrapolation of oral studies to other routes is the only method available.
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 120 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The acute dermal toxicity study returned a negative result. therefore the repeat-dose study result was used.
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
160 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
16 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The acute dermal toxicity study returned a negative result. therefore the repeat-dose study result was used.
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.08 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
1
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
1
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Although S-205 shows no indication of toxicity, a full set of DNEL's have been calculated for completeness and compliance with the TCC.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.67 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):
600
Modified dose descriptor starting point:
NOAEC
Value:
7 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
There are no inhalation studies for this substance and the extrapolation of oral studies to other routes is the only method available.
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
560 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEC
Value:
112 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
There are no inhalation studies for this substance and the extrapolation of oral studies to other routes is the only method available.
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.67 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
560 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The acute dermal toxicity study returned a negative result. Therefore the repeat-dose study result was used.
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
160 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
1 600 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The acute dermal toxicity study returned a negative result. therefore the repeat-dose study result was used.
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
240
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
1
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
1
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.67 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:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Results regarded as satisfactory, study Klimisch 1.
AF for differences in duration of exposure:
6
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
1
Justification:
Klimisch 1
AF for remaining uncertainties:
1
Justification:
No other uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
80 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
16 000
Explanation for the modification of the dose descriptor starting point:
Acute oral study used.
AF for dose response relationship:
1
Justification:
This is regarded satisfactory as the acute oral toxicity is a simple procedure
AF for interspecies differences (allometric scaling):
4
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for other interspecies differences:
2.5
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for intraspecies differences:
10
Justification:
Default assessment factor from ECHA REACH guidelines.
AF for the quality of the whole database:
2
Justification:
The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). However, the study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions).
AF for remaining uncertainties:
1
Justification:
No other uncertainties.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Although S-205 shows no indication of toxicity, a full set of DNEL's have been calculated for completeness and compliance with the TCC.

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