Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.