Benzoic acid, 3,5-diamino-4-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-2-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:?)

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

47 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):

75

Modified dose descriptor starting point:

NOAEC

Value:

3 526 mg/m³

Explanation for the modification of the dose descriptor starting point:

The NOAEC of inhalation is derived from the NOAEC of repeated dose oral test. According to REACH R.8 Figure R. 8-3, corrected inhalatory NOAEC = oral NOAEL * (1/sRVrat) * (ABSoral-rat/ABSinh-rat) * (ABSinh-rat/ABSinh-human) *(sRVhuman/wRV). sRVrat = 0.38 mg/m3; ABSoral-rat/ ABSinh-rat = 2; ABSin-rat/ABSinh-humna=1; sRV human/ wRV = 0.67.

AF for dose response relationship:

1

AF for differences in duration of exposure:

6

Justification:

Subacute to chronic

AF for interspecies differences (allometric scaling):

1

Justification:

In the inhalation, allmetric scaling is not taken into account.

AF for other interspecies differences:

2.5

Justification:

Other difference

AF for intraspecies differences:

5

Justification:

Worker

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

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:

3.3 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 NOAEC of dermal is derived from the NOAEC of repeated dose oral test. According to REACH R.8, corrected dermal NOAEC = oral NOAEL * (ABSoral-rat/ABSdermal-rat)*(ABSdermal-rat/ABSdermal-human). ABSoral-rat/ ABSdermal-rat = 1; ABSdermal-rat/ ABSdermal-human = 1.

AF for dose response relationship:

1

AF for differences in duration of exposure:

6

Justification:

Subacute to chronic

AF for interspecies differences (allometric scaling):

4

Justification:

Rat to human

AF for other interspecies differences:

2.5

Justification:

Other difference

AF for intraspecies differences:

5

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

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

Most sensitive endpoint:

skin irritation/corrosion

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)

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

11.6 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):

150

Modified dose descriptor starting point:

NOAEC

Value:

1 739 mg/m³

Explanation for the modification of the dose descriptor starting point:

The NOAEC of inhalation is derived from the NOAEC of repeated dose oral test. According to REACH R.8 Figure R. 8-3, corrected inhalatory NOAEC = oral NOAEL * (1/sRVrat) * (ABSoral-rat/ABSinh-rat)* (ABSinh-rat/ABSinh-human). sRVrat = 1.15 mg/m3; ABSoral-rat/ ABSinh-rat = 2; ABSin-rat/ABSinh-humna=1.

AF for dose response relationship:

1

AF for differences in duration of exposure:

6

Justification:

Subacute to chronic

AF for interspecies differences (allometric scaling):

1

AF for other interspecies differences:

2.5

Justification:

Other difference

AF for intraspecies differences:

10

Justification:

Consumer

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

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:

1.7 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 NOAEC of dermal is derived from the NOAEC of repeated dose oral test. According to REACH R.8, corrected dermal NOAEC = oral NOAEL * (ABSoral-rat/ABSdermal-rat)*(ABSdermal-rat/ABSdermal-human). ABSoral-rat/ ABSdermal-rat = 1; ABSdermal-rat/ ABSdermal-human = 1.

AF for dose response relationship:

1

AF for differences in duration of exposure:

6

Justification:

Subacute to chronic

AF for interspecies differences (allometric scaling):

4

AF for other interspecies differences:

2.5

Justification:

Other differences

AF for intraspecies differences:

10

Justification:

Consumer

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

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

Most sensitive endpoint:

skin irritation/corrosion

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:

1.7 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 NOAEC of oral is derived from the NOAEC of repeated dose oral test. According to REACH R.8, corrected oral NOAEC = oral NOAEL * (ABSoral-rat/ABSoral-human). ABS oral-rat/ABS oral-human = 1

AF for dose response relationship:

1

AF for differences in duration of exposure:

6

Justification:

Subacute to chronic

AF for interspecies differences (allometric scaling):

4

AF for other interspecies differences:

2.5

Justification:

Other differences

AF for intraspecies differences:

10

Justification:

Consumer

AF for the quality of the whole database:

1

AF for remaining uncertainties:

1

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)