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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:
1.65 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
82.4 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
41.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

Based on repeated dose inhalation studies (28 -d, 90 -days, and 2 -years) in rats a lowest NOAEC of 82.4 mg/m³  for 6h per day on 5 days per week was determined in a subchronic study.

Conversion of the inhalatory rat NOAEC (starting point) into in a corrected inhalatory NOAEC (modified starting point):

- assumptions (for workers): 8h exposure/day; inhalation absorption rat = inhalation absorption human

corrected NOAEC = NOAEC, inhal * (6 h/d) / (8 h/d) * (6.7 m3 (8h) / 10 m3 (8h)) = 41.2 mg/m3 * 0.75 * 0.67 =41.4 mg/m3

AF for dose response relationship:
1
Justification:
Starting point is a NOAEC. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
AF for differences in duration of exposure:
2
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8 an assessment factor of 2 for duration extrapolation sub-chronic to chronic is taken into consideration
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA Guidance an allometric scaling factor is not applicable when setting an inhalation DNEL based on an inhalation animal study (see Appendix R.8-2 of TGD (ECHA, Nov. 2012)), therefore AF 1 is chosen.
AF for other interspecies differences:
2.5
Justification:
Default value by ECHA for all remaining systemic interspecies differences (see Table R.8-6 Default Assessment Factors of TGD (ECHA, Nov. 2012)
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance an default factor for Intraspecies differences (factor 5) is chosen (see Table R.8-6 Default Assessment Factors of TGD (ECHA, Nov. 2012).
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered necessary.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.25 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.65 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
Value:
41.4 mg/m³
AF for dose response relationship:
1
Justification:
Starting point is a NOAEC. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
AF for differences in duration of exposure:
2
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8 an assessment factor of 2 for duration extrapolation sub-chronic to chronic is taken into consideration
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA Guidance an allometric scaling factor is not applicable when setting an inhalation DNEL based on an inhalation animal study (see Appendix R.8-2 of TGD (ECHA, Nov. 2012)), therefore AF 1 is chosen.
AF for other interspecies differences:
2.5
Justification:
Default value by ECHA for all remaining systemic interspecies differences (see Table R.8-6 Default Assessment Factors of TGD (ECHA, Nov. 2012)
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance a default factor for Intraspecies differences (factor 5, workers) is chosen.
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered necessary.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.25 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.167 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
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Based on a repeated dose oral study in rats (NOAEL = 50 mg/kg bw/day) assuming a worst case 100% dermal absorption.

AF for dose response relationship:
1
Justification:
A standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
AF for differences in duration of exposure:
6
Justification:
Based on a subacute oral toxicity study a NOAEL of 50 mg/kg bw/day with the default exposure duration assessment factor of 6 (subacute-chronic) is considered.
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov. 2012) for interspecies extrapolation the default factor of 4 for metabolic differences between rat and humans is considered for both the oral and the dermal exposure route.
AF for other interspecies differences:
2.5
Justification:
A further assessment factor of 2.5 is used by default for dermal/oral exposure according to ECHA TGD (ECHA, Nov. 2012).
AF for intraspecies differences:
5
Justification:
Default safety factor accounting for intraspecies differences in susceptibility (factor 5 for workers) is assumed as described in chapter R 8.4.3.3 of TGD (ECHA, Nov. 2012).
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered necessary.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.835 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

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
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The test substance is not intended for consumer uses. Therefore no DNEL for the general population is derived.

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:
0.083 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
Dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Derivation of DNEL for repeated oral exposure for general population (consumers) from NOAEL of the 28 day rat oral toxicity study. Toxicokinetic studies with experimental animals (rats) indicated that oral absorption was complete (100%). The frequency for exposure for rats and humans via the environment is estimated to be daily. No correction for NOAEL necessary (see R 8.4.2 of TGD).

AF for dose response relationship:
1
Justification:
Starting point is a NOAEL. Thus standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov 2012).
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8 an assessment factor of 6 for duration extrapolation sub-acute to chronic is taken into consideration.
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA TGD (see section 8.4.3.1 of TGD; ECHA, Nov. 2012) for interspecies extrapolation the default factor of 4 for metabolic differences between rat and humans is considered for both the oral and the dermal exposure route.
AF for other interspecies differences:
2.5
Justification:
A further assessment factor of 2.5 is used by default for dermal/oral exposure according to ECHA TGD (ECHA, Nov. 2012).
AF for intraspecies differences:
10
Justification:
According to ECHA Guidance a default factor for Intraspecies differences (factor 10 for general population) is chosen.
AF for the quality of the whole database:
1
Justification:
Because of good/standard quality of the database the standard assessment factor 1 is used as described in chapter R 8.4.3.1 of TGD (ECHA, Nov. 2012).
AF for remaining uncertainties:
1
Justification:
No further assessment factors are considered necessary.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.083 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The use of the test substance is restricted only to industrial and professional applications. Hence there is no need to derive DNEL´s for general population (consumers).

An indirect exposure of man via the environment might occur through ingestion of foodstuff or drinking water. Therefore, a systemic oral long-term DNEL for general population is derived and will be used to assess any possible risk that could result from indirect exposure of man via the environment .