Registration Dossier
Registration Dossier
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EC number: 213-999-5 | CAS number: 1071-93-8
Toxicological Summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
