Registration Dossier
Registration Dossier
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EC number: 701-127-0 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.04 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 1
- Justification:
- Identical local effects assumed in monkeys and humans.
- AF for differences in duration of exposure:
- 1
- Justification:
- Chronic study available.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable to local effects that are not dependent on metabolic rate or systemic absorption.
- AF for other interspecies differences:
- 2.5
- Justification:
- For effects on the respiratory tract, even when the mechanism indicates simple destruction of membranes due to a physico-chemical effect such as pH, it is prudent to assume humans will be more sensitive than animals.
- AF for intraspecies differences:
- 5
- Justification:
- Defaut value (worker) assigned because information on intraspecies variation for local (concentration-dependent) effects is scarce and ECHA guidance makes no attempt to refine dafault intraspecies factors considered appropriate for systemic effects.
- AF for the quality of the whole database:
- 2
- Justification:
- An increased assessment factor is considered sensible despite the multi-constituent substance comprising > 80 % sulphuric acid because underlying data is taken from published literature to prevent unnecessary exposure of vertebrate animals to a substance that is designed to be highly corrosive.
- AF for remaining uncertainties:
- 1
- Justification:
- An increased assessment factor is considered unnecessary because the multi-constituent substance consists of > 80 % sulphuric acid and route specific data are available.
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
The multi-constituent test material is designed to be highly corrosive and is used under industrial conditions where strict risk managment measures and a high standard of training may be assumed. No exposure is predicted via the dermal route under normal operating conditions but a long-term local DNEL has been derived to address the small possibility of local effects following prolonged exposure via the inhalation route.
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.
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