Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.3 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):
25
Modified dose descriptor starting point:
NOAEC
DNEL value:
182 mg/m³
Explanation for the modification of the dose descriptor starting point:

systemic changes seen in oral 90-day study

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
subchronic study
AF for interspecies differences (allometric scaling):
1
Justification:
already in calculation of sRV
AF for other interspecies differences:
2.5
Justification:
systemic effects
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
well performed study
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
15 000 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):
100
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

systemic changes seen in oral 90-day study

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
subchronic study
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
systemic effects
AF for intraspecies differences:
5
Justification:
worker
AF for the quality of the whole database:
1
Justification:
well performed study
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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

Additional information - workers

All DNELs for repeated exposure are based on the results of the 90 -day oral toxicity study.

Because no developmental and reproduction toxicity was noted with GLDA-Na4 up to levels of at least 1000 mg/kg bw in rats, and no developmental toxicity was observed in rabbits, DNELs for these endpoints were not established.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 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):
50
Modified dose descriptor starting point:
NOAEC
DNEL value:
90 mg/m³
Explanation for the modification of the dose descriptor starting point:

systemic effects in 90-day study

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
subchronic study
AF for interspecies differences (allometric scaling):
1
Justification:
already done in sRV
AF for other interspecies differences:
2.5
Justification:
systemic effects
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
well performed study
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
7 500 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):
200
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

systemic effects in 90-day study

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
subchronic study
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
systemic effects
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
well performed study
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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:
1.5 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):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

not applicable

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
2
Justification:
subchronic study
AF for interspecies differences (allometric scaling):
4
Justification:
standard factor
AF for other interspecies differences:
2.5
Justification:
systemic effects
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
well performed study
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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

Additional information - General Population

See above at worker exposure.