Registration Dossier

Manufacture, use & exposure

Formulation

Documentsopen allclose all

Formulation

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC2: Formulation into mixture
Name of activity / technique:
This substance does not meet the criteria for human health or environmental classification. In addition, this substance does not meet PBT/vPvB criteria. Therefore, a quantitative assessment is not required.
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
The R65 risk phrase (Harmful: may cause lung damage if swallowed) relates to potential for aspiration, a non-quantifiable hazard determined by physical properties that can only occur following accidental oral exposure or non-intended uses. A DNEL cannot be derived. This general qualitative CSA approach aims to reduce/avoid contact or incidents with the substance. However, implementation of risk management measures (RMMs) and operational conditions (OCs) need to be proportional to the degree of concern for the health hazard presented by the substance. Exposures should be controlled to at least the levels that represent an acceptable level of risk such that the implementation of the chosen RMMs will ensure that the likelihood of an event occurring due to the substance hazard is negligible, and the risk is considered to be controlled to a level of no concern. There are no routine anticipated exposures by ingestion related to any supported uses of the substance. The risk arising from aspiration hazard is solely related to the physicochemical properties of the substance i.e. viscosity. The risk can be controlled by implementing risk management measures tailored to this specific risk. For any substance, classified as R65, these measures will be communicated via the safety data sheet by use of the following phrase:
• Do not ingest. If swallowed then seek immediate medical assistance.
Furthermore it should be noted that where the substance is sold for use in lamp oils and grill lighters by the general public (Consumers), then these must be visibly, legibly and indelibly marked as follows, in accordance with REACH Annex XVII update of 1.4.2010:
- Keep lamps filled with this liquid out of the reach of children.

The R66 risk phrase (Repeated exposure may cause skin dryness and cracking) is generally applied to petroleum substances and solvents that have the capacity to extract lipids from the skin and that are not classified as irritant. R66 does not re... (see attached file)
Substance supplied to that use in form of:
as such
Related assessment:
use assessed in a joint CSR

Contributing scenario for the environment (related to workers activities)

Contributing scenario for the workers

Conditions of use for workers

Technical and organisational conditions and measures

Technical and organisational conditions

Formulation

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC1: Manufacture of the substance
Environmental release category (ERC):
ERC4: Use of non-reactive processing aid at industrial site (no inclusion into or onto article)
Environmental release category (ERC):
ERC5: Use at industrial site leading to inclusion into/onto article
Environmental release category (ERC):
ERC6a: Use of intermediate
Environmental release category (ERC):
ERC6b: Use of reactive processing aid at industrial site (no inclusion into or onto article)
Environmental release category (ERC):
ERC6c: Use of monomer in polymerisation processes at industrial site (inclusion or not into/onto article)
Environmental release category (ERC):
ERC6d: Use of reactive process regulators in polymerisation processes at industrial site (inclusion or not into/onto article)
Environmental release category (ERC):
ERC7: Use of functional fluid at industrial site
Environmental release category (ERC):
ERC2: Formulation into mixture
Environmental release category (ERC):
ERC3: Formulation into solid matrix
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 15: Use as laboratory reagent

Formulation

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC4: Use of non-reactive processing aid at industrial site (no inclusion into or onto article)
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 10: Roller application or brushing
Process category (PROC):
PROC 15: Use as laboratory reagent

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category formulated:
PC 11: Explosives
PC 13: Fuels
Substance supplied to that use in form of:
as such
in a mixture
Related assessment:
use assessed in a joint CSR

Formulation

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC2: Formulation into mixture
Name of activity / technique:
This substance does not meet the criteria for human health or environmental classification. In addition, this substance does not meet PBT/vPvB criteria. Therefore, a quantitative assessment is not required.
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 15: Use as laboratory reagent
Name of activity / technique:
The R65 risk phrase (Harmful: may cause lung damage if swallowed) relates to potential for aspiration, a non-quantifiable hazard determined by physical properties that can only occur following accidental oral exposure or non-intended uses. A DNEL cannot be derived. This general qualitative CSA approach aims to reduce/avoid contact or incidents with the substance. However, implementation of risk management measures (RMMs) and operational conditions (OCs) need to be proportional to the degree of concern for the health hazard presented by the substance. Exposures should be controlled to at least the levels that represent an acceptable level of risk such that the implementation of the chosen RMMs will ensure that the likelihood of an event occurring due to the substance hazard is negligible, and the risk is considered to be controlled to a level of no concern. There are no routine anticipated exposures by ingestion related to any supported uses of the substance. The risk arising from aspiration hazard is solely related to the physicochemical properties of the substance i.e. viscosity. The risk can be controlled by implementing risk management measures tailored to this specific risk. For any substance, classified as R65, these measures will be communicated via the safety data sheet by use of the following phrase:
• Do not ingest. If swallowed then seek immediate medical assistance.
Furthermore it should be noted that where the substance is sold for use in lamp oils and grill lighters by the general public (Consumers), then these must be visibly, legibly and indelibly marked as follows, in accordance with REACH Annex XVII update of 1.4.2010:
- Keep lamps filled with this liquid out of the reach of children.

The R66 risk phrase (Repeated exposure may cause skin dryness and cracking) is generally applied to petroleum substances and solvents that have the capacity to extract lipids from the skin and that are not classified as irritant. R66 does not re... (see attached file)
Product category formulated:
PC 21: Laboratory chemicals
Substance supplied to that use in form of:
as such
Related assessment:
use assessed in a joint CSR

Contributing scenario for the environment (related to workers activities)

Contributing scenario for the workers

Conditions of use for workers

Technical and organisational conditions and measures

Technical and organisational conditions

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 5: Mixing or blending in batch processes
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 9: Transfer of substance or mixture into small containers (dedicated filling line, including weighing)
Process category (PROC):
PROC 14: Tabletting, compression, extrusion, pelletisation, granulation
Process category (PROC):
PROC 15: Use as laboratory reagent

Formulation

Contributing activity / technique for the environment
Environmental release category (ERC):
ERC2: Formulation into mixture
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 10: Roller application or brushing
Process category (PROC):
PROC 15: Use as laboratory reagent
Product category formulated:
PC 11: Explosives
PC 13: Fuels
Substance supplied to that use in form of:
as such
in a mixture
Related assessment:
use assessed in a joint CSR

Formulation

Contributing activity / technique for the environmentopen allclose all
Environmental release category (ERC):
ERC4: Use of non-reactive processing aid at industrial site (no inclusion into or onto article)
Environmental release category (ERC):
ERC3: Formulation into solid matrix
Contributing activity / technique for workersopen allclose all
Process category (PROC):
PROC 1: Chemical production or refinery in closed process without likelihood of exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 2: Chemical production or refinery in closed continuous process with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 3: Manufacture or formulation in the chemical industry in closed batch processes with occasional controlled exposure or processes with equivalent containment conditions
Process category (PROC):
PROC 4: Chemical production where opportunity for exposure arises
Process category (PROC):
PROC 8a: Transfer of substance or mixture (charging and discharging) at non-dedicated facilities
Process category (PROC):
PROC 8b: Transfer of substance or mixture (charging and discharging) at dedicated facilities
Process category (PROC):
PROC 13: Treatment of articles by dipping and pouring