Toluenesulphonamide

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

5.9 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

6

Modified dose descriptor starting point:

NOAEC

Value:

35.3 mg/m³

Explanation for the modification of the dose descriptor starting point:

Selected starting point is a NOAEL of 20 mg/kg bw/day. The corrected 8 hr inhalation NOAEC for workers is NOAEL (20 mg/kg) * 1.76 mg/m3 = 35.3 mg/m3. No factor 2 route extrapolation from oral to inhalation. Kinetic studies indicate a rapid and complete absorption via oral route, and also via inhalation 100% absorption is assumed.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

2

Justification:

The default assessment factor for sub-chronic to chronic extrapolation (AF 2)

AF for interspecies differences (allometric scaling):

1

Justification:

Already included in NOAEC calculation

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

3

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 3 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results.

AF for remaining uncertainties:

1

Justification:

No additional uncertainties are identified.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

4.2 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

24

Modified dose descriptor starting point:

NOAEL

Value:

100 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Selected starting point is a NOAEL of 20 mg/kg bw/day. Kinetic studies indicate a rapid and complete absorption via oral route, but dermal absorption is maximal 20%. The corrected dermal NOAEL for workers is NOAELoral (20 mg/kg) / 20% = 100 mg/kgbw/day.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

2

Justification:

The default assessment factor for sub-chronic to chronic extrapolation (AF 2)

AF for interspecies differences (allometric scaling):

4

Justification:

Default allometric scaling rat to human

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

3

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 3 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results.

AF for remaining uncertainties:

1

Justification:

No additional uncertainties are 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.7 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

10

Modified dose descriptor starting point:

NOAEC

Value:

17.4 mg/m³

Explanation for the modification of the dose descriptor starting point:

Selected starting point is a NOAEL of 20 mg/kg bw/day. The corrected 8 hr inhalation NOAEC for workers is NOAEL (20 mg/kg) * 1/1.15 mg/m3 = 17.4 mg/m3. No factor 2 route extrapolation from oral to inhalation. Kinetic studies indicate a rapid and complete absorption via oral route, and also via inhalation 100% absorption is assumed.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

2

Justification:

The default assessment factor for sub-chronic to chronic extrapolation (AF 2)

AF for interspecies differences (allometric scaling):

1

Justification:

Already included in NOAEC calculation

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

5

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results.

AF for remaining uncertainties:

1

Justification:

No additional uncertainties are identified.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

Acute/short term exposure

Hazard assessment conclusion:

hazard unknown (no further information necessary)

DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2.5 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

other: ECETOC

Overall assessment factor (AF):

40

Modified dose descriptor starting point:

NOAEL

Value:

100 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Selected starting point is a NOAEL of 20 mg/kg bw/day. Kinetic studies indicate a rapid and complete absorption via oral route, but dermal absorption is maximal 20%. The corrected dermal NOAEL for general population is NOAELoral (20 mg/kg) / 20% = 100 mg/kgbw/day.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

2

Justification:

The default assessment factor for sub-chronic to chronic extrapolation (AF 2)

AF for interspecies differences (allometric scaling):

4

Justification:

Default allometric scaling rat to human

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

5

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results.

AF for remaining uncertainties:

1

Justification:

No additional uncertainties are 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:

DNEL (Derived No Effect Level)

Value:

0.5 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):

40

Modified dose descriptor starting point:

NOAEL

Value:

20 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Not applicable.

AF for dose response relationship:

1

Justification:

No specific concerns; starting point is NOAEL.

AF for differences in duration of exposure:

2

Justification:

The default assessment factor for sub-chronic to chronic extrapolation (AF 2)

AF for interspecies differences (allometric scaling):

4

Justification:

Default allometric scaling rat to human

AF for other interspecies differences:

1

Justification:

ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5; therefore a factor of 1 has been applied.

AF for intraspecies differences:

5

Justification:

ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for consumers/general population is 5 (Actually considered as sufficient for the combined remaining inter-species and intra-species factors)

AF for the quality of the whole database:

1

Justification:

Available data derived from valid studies showing consistent results.

AF for remaining uncertainties:

1

Justification:

No additional uncertainties are identified.

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - General Population

These substances are mainly applied in professional or industrial settings. Consequently, consumers/general population will generally not be exposed.