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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:
17.5 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):
400
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
175 mg/m³
Explanation for the modification of the dose descriptor starting point:

Guidance on information requirements and chemical safety assessment, chapter R.8: Characterisation of dose [concentration]-response for human health (version 2.1, 2012):

NOAEL (oral, rat) -> NOAEC (inhalation, workers):

rat-human : 4

body weight human: 70 kg

inhalation worker = 10 m³/person/day

NOAEC worker = 100 mg/kg bw/day/4 × 70 kg/10 m³ = 175 mg/m³

AF for dose response relationship:
1
Justification:
no indication of need for adjustment
AF for differences in duration of exposure:
2
Justification:
subchronic - chronic
AF for interspecies differences (allometric scaling):
1
Justification:
rat - human: 4; already accounted for in modificaiton of starting point
AF for other interspecies differences:
1
Justification:
no additional factor deemed necessary
AF for intraspecies differences:
5
Justification:
workers - default assessment factor ECHA guidance
AF for the quality of the whole database:
1
Justification:
full dataset available
AF for remaining uncertainties:
1
Justification:
full dataset available
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:
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

In the available acute oral and inhalation toxicity test no deaths, and no clinical signs of reaction to treatment were reported.

Only low oral and inhalation absorptions are predicted from the phys-chem properties of adipic acid dihydrazide.

The dermal absorption is predicted to be even lower compared to the oral or inhalation route.

No accumulation is expected, based on the low log Pow.

No irritant, sensitizer or mutagen, no indication for carcinogenicity or reproduction toxicity.

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
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:
no hazard identified
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