Carbonic acid, compound with 2-aminoethanol (1:2)

Toxicological Summary

Workers - 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:

DNEL (Derived No Effect Level)

Value:

3.3 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

other: ECETOC Technical Report 110

Overall assessment factor (AF):

3

Dose descriptor:

NOAEC

AF for dose response relationship:

1

AF for differences in duration of exposure:

1

Justification:

per ECETOC (2003).

AF for interspecies differences (allometric scaling):

1

Justification:

not applicable to local effects

AF for other interspecies differences:

1

Justification:

per ECETOC (2003. For water souble gases and vapours an overestimation of effects in humans is seen in roden data are directly extrapolated to humans.

AF for intraspecies differences:

3

Justification:

per ECETOC (2003) assessment of data on respiratory irritants in human volunteers.

AF for the quality of the whole database:

1

Justification:

good/standard quality of the dataset

AF for remaining uncertainties:

1

Justification:

not applicable to local effects

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:

1 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):

120

Modified dose descriptor starting point:

NOAEL

Value:

120 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

Based on available data on dermal absorption in rats and humans from in vitro and in vivo tests, as well as an assumption of 100% absorption via oral exposure and approximately 40% dermal absoption for worker.

AF for dose response relationship:

1

AF for differences in duration of exposure:

6

AF for interspecies differences (allometric scaling):

4

AF for other interspecies differences:

1

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

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:

no hazard identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

2 mg/m³

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

5

Dose descriptor:

NOAEC

AF for dose response relationship:

1

AF for differences in duration of exposure:

1

AF for interspecies differences (allometric scaling):

1

Justification:

not applicable to local effects

AF for other interspecies differences:

1

AF for intraspecies differences:

5

Justification:

per ECETOC (2003) assessment of data on respiratory irritants in human volunteers.

AF for the quality of the whole database:

1

Justification:

good/standard quality of the dataset

AF for remaining uncertainties:

1

Justification:

not applicable to local effects

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:

0.24 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):

240

Modified dose descriptor starting point:

NOAEL

Value:

60 mg/kg bw/day

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:

3.75 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):

80

Modified dose descriptor starting point:

NOAEL

Value:

300 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

not applicable

AF for dose response relationship:

1

AF for differences in duration of exposure:

2

Justification:

subcronic to chronic

AF for interspecies differences (allometric scaling):

4

AF for other interspecies differences:

1

AF for intraspecies differences:

10

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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified