Registration Dossier

Diss Factsheets

Administrative data

First-aid measures

See also attached safety data sheet

4.1       Description of First Aid Measures

             

      Ingestion:       Give 2-4 cups full of milk or water, do not induce vomiting; seek medical advice if symptoms occur.

             

      Skin contact:       Wash with plenty of soap and water. Remove contaminated clothing and shoes. Get medical attention if symptoms occur. Wash clothing before reuse. Clean shoes before reuse.

             

      Eye contact:       Causes serious eye irritation. Rinse immediately eye with plenty of low pressure water for at least 15 minutes.

Remove any contact lenses. Get medical attention.

             

      Inhalation:       Move the exposed person to fresh air at once. Seek medical advice if symptoms occur.

             

      First Aider Protection:       None specific.

             

4.2       

Most important symptoms and effects, both acute and delayed

             

      Ingestion:       Slight irritation of the gastro-intestinal tract may occur.

             

      Skin contact:       Slight irritation, redness may occur

             

      Eye contact:       Causes serious eye irritation

             

      Inhalation:       None specific

             

4.3       Indication of immediate medical attention and special treatment needed

             

      General advice:       Notes to physician: Treat symptomatically. Contact poison treatment specialist if large quantities have

      been ingested or inhaled.

Specific treatments : none.

Fire-fighting measures

See also attached safety data sheet

5.1       Extinguishing media        (small and large fires)

             

      Small Fire:       Water, water mist, foam, dry powder, CO2

             

      Large Fire:       Water, water mist, foam, dry powder, CO2

             

      Avoid:       None

             

5.2.1       Specific Hazards:       This product is toxic to aquatic life with long lasting effects. Fire water contaminated with this material must be contained and prevented from being discharged to any waterway, sewer or drain.

Hazardous combustion products : Decomposition products may include the following materials: COx

             

5.2.2       Protective equipment and advice for fire fighters:       Self-contained breathing apparatus and full protective clothing. Clothing for fire-fighters (including helmets, protective boots and gloves) conforming to European standard EN 469 will provide a basic level of protection for chemical incidents.

Accidental release measures

See also attached safety data sheet

6.1       Personal precautions, protective equipment and emergency measures

             

6.1.1       For non-emergency personnel:       No action shall be taken involving any personal risk or without suitable training. Keep

unnecessary and unprotected personnel from entering. Do not touch or walk through spilled material. Put on appropriate personal protective

equipment (see Section 8).

             

6.1.2       For emergency responders:       If specialised clothing is required to deal with the spillage, take note of any information in Section 8 on suitable and unsuitable materials. See also the information in "For non-emergency personnel".

             

6.2       Environmental precautions:       Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains and sewers.

Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways, soil or air). Water polluting material. May be toxic to the environment if released in large quantities. Collect spillage.

             

6.3       Methods and material for containment and cleaning up

             

6.3.1       For containment:       Small spill : Collect spill with without creating dust, then place in a designated, labeled waste container. Dispose of via a licensed waste disposal contractor.

Large spill : Move containers from spill area. Prevent entry into sewers, water courses, basements or confined areas. Collect spill without creating dust, then place in a designated, labeled waste container. Dispose of via a licensed waste disposal contractor.

Note: see Section 1 for emergency contact information and Section 13 for waste disposal.

             

6.3.2       For cleaning up:       See Section 6.3.1

             

6.3.3       Other information:       None specific

             

6.4       Reference to other sections:       See Section 1 for emergency contact information.

See Section 8 for information on appropriate personal protective equipment.

See Section 13 for additional waste treatment information.

Handling and storage

See also attached safety data sheet

7.1       Precautions for Safe Handling:       Protective measures:

Put on appropriate personal protective equipment (see Section 8). Do not handle until all safety precautions have been read and understood.

Do not get in eyes or on skin. Do not ingest. Avoid release to the environment. Keep in the original container or an approved alternative made from a compatible material, kept tightly closed when not in use. Empty containers retain product residue and can be hazardous. Do not reuse container.

Advice on general occupational hygiene: Eating, drinking and smoking should be prohibited in areas where this material is handled, stored and

processed. Workers should wash hands and face before eating, drinking and smoking. Remove contaminated clothing and protective equipment

before entering eating areas. See also Section 8 for additional information on hygiene measures.

             

7.2       Conditions for safe storage, including any incompatibilities:       Store in accordance with local regulations. Store in original container

protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials (see Section 10) and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent

spillage. Do not store in unlabeled containers. Use appropriate containment to avoid environmental contamination.

             

7.3       Specific end uses:       Recommendations and Industrial Sector specific solutions: use as UV absorber in cosmetics and

plastics

Transport information

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Marine transport (UN RTDG/IMDG)

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Exposure controls / personal protection

See also attached safety data sheet

8.1       Control Parameters       

LD50 (oral, rat)            8600 mg/kg

Occupational exposure limits

None

Derived no effect levels (DNELs)

             Workers              General population

Oral              not relevant              1.18 mg/kg bw/day

Dermal              2.36 mg/kg bw/day       1.18 mg/kg bw/day

Inhalation              2.08 mg/m3              0.513 mg/m3

Predicted no effect concentrations (PNECs)

aqua-freshwater:                     0.0327 mg/L

aqua-marine water:                     0.00327 mg/L

aqua-intermittent:                     0.327 mg/L

sewage treatment plant:       0.914 mg/L

sediment-freshwater:                     35.12 mg /kg dw

sediment-marine water:       3.512 mg /kg dw

soil:                     12.3 mg /kg dw

INDUSTRIAL WORKERS TOXICITY

The CHESAR Tool version 2.2.0, exposure model for this substance shows for

•       indoor industrial activities

•       with an advanced occupational health and safety system

•       taking more than 4 hours/day

•       with local exhaust ventilation (LEV) present (and running)

the following long term systemic exposures:

                  Inhalation (mg/m3)       dermal (mg/kg/day)       RCR (inhal)       RCR (dermal)                               RCR (total)

PROC2    0.0007              0.137              0.0003       0.058              0.058

Use in closed, continuous process with occasional controlled exposure

PROC3    0.007              0.069              0.003       0.029              0.032

Use in closed batch process (synthesis or formulation)

PROC5    0.035              1.371              0.017       0.581                                  0.598

Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)

PROC8a   0.035              1.371              0.017       0.581              0.598

Transfer of substance or preparation (charg-ing/discharging) from/to vessels/large containers at non-dedicated facilities

PROC8b   0.003              0.686              0.002       0.291              0.293

Transfer of chemicals from/to vessels/large containers at dedicated facilities

PROC9    0.007              0.686              0.003       0.291              0.294

Transfer of chemicals into small containers (dedicated filling line)

PROC14   0.007              0.343                                  0.003       0.145              0.148

Production of preparations or articles by tabletting, compression, extrusion, pelletisation

PROC15   0.007              0.034              0.003       0.014              0.017

Use of laboratory reagents in small scale laboratories

Notes:

•       The outcome of ECETOC TRAM v3 (10 April 2012) is identical to CHESAR v2.2.0

•       Good general ventilation is assumed in all cases (3-5 air exchanges per hour)

•       Dustiness of the substance was set at “low”

•       LEV is considered for both inhalation and dermal exposures and its efficiencies are as follows:

o       For PROC8b LEV reduces both inhalation and dermal exposure with 95%

o       For all other PROCs LEV reduces both inhalation and dermal exposure with 90%

•       The applied RMMs/OCs will also control the risks relating to possible eye irritation

The RMMs/OCs for the use of 2,4-dihydroxybenzophenone in an industrial environment:

•       Indoor industrial activities taking more than 4 hours per day

•       With an advanced occupational health and safety system

•       Local Exhaust Ventilation (LEV) and good general ventilation (3-5 air changes per hour)

•       Wear approved safety goggles for eye protection

•       Low dustiness of the substance

CONSUMER TOXICITY

To cover PC39 (cosmetics & personal care products) the consumer exposure scenario was calculated with the ConsExpo tool (version 5.0.b01). The default scenario for sunscreen lotions was used (application 75 times per year; average adult weight 65 kg; exposed dermal area 17500 cm2; application amount of lotion 10 gr; exposure time 150 minutes per application; final on-skin percentage of 2,4-dihydroxybenzophenone 6 %; dermal uptake fraction 50 %).

The result was a total dermal systemic dose of 0.95 mg/kg/day, or an RCR of 0.805

Note: the maximum concentration of 2,4-dihydroxybenzophenone allowed in sunscreen products is 6% under the assumption that the uptake of this substance through the skin is not more than 50%.

8.2       Exposure controls

Avoid contact with eyes. Do not swallow. Wear suitable protective equipment. Ensure that eyewash stations and safety showers are close to the workstation location. Remove soiled or soaked clothing. Clean skin after work. At work do not eat, drink, smoke or take drugs. Keep away from food, drink and animal feeding stuffs.

             

8.2.1       Engineering controls:       Generic local exhaust ventilation (LEV) in the production area is always required to control inhalation

exposure.

             

8.2.2       Personal protective equipment:       

Respiratory protection

Good general exhaust ventilation of the work area

Hand protection

Wear appropriate protective gloves to prevent skin exposure.

Eye and Face protection

Use safety goggles (EN 166)

Skin and body protection

Use clothing and boots as usual in the chemical industry.

             

8.2.3       Environmental exposure controls:       Take precautionary measures against discharges into the environment

LC50 (fish: oryzias latipes, 96h):              3.7 mg/l (experimental)

Chronic value (NOEC, SW fish)              1.454 mg/l (calculated)

EC50 (Daphnia, 48h):                     7.86 mg/l (experimental)

Chronic value (NOEC, Daphnia)              5.766 mg/l (calculated)

EC50 (algae, 96h):                     2.120 mg/l (calculated)

Chronic value (NOEC, algae)                     0.327 mg/l (calculated)

IGC50 (Tetrahymena, 48h)  (STP)                                  9.14 mg/l (experimental)

LC50 (Earthworm, 28d)                     1230 mg/kg soil dw (calculated)

The same CHESAR tool predicts the following for the relevant ERC2 (at 100 ton/year per site; 1 ton/day per site; fraction of tonnage to

region = 100%), ERC5 (at 30 ton/year per site; 150 kg/day per site; fraction of tonnage to region = 100%), ERC8d (at 100 ton/year;

fraction of tonnage to region = 10%), and ERC10b (at 100 t/y; fraction of tonnage to region 10%):

                               ERC2                                 ERC5                 ERC8d                                         ERC10b

                    PEC                    RCR          PEC                RCR       PEC       RCR       PEC       RCR

for local freshwater (mg/L)              0.009       0.271      0.033        0.999       0.003       0.079       0.003       0.085

for local freshwater sediment (mg/kgdwt)       1.126       0.032      4.152        0.118       0.328       0.009       0.353       0.01

for local marine water (mg/L)              0.0009       0.271      0.003        0.999       0.0003       0.079       0.0003       0.085

for local marine sediments (mg/kgdwt)       0.113       0.032      0.415        0.118       0.033       0.009       0.035       0.01

in STP (mg/L)                     0.087       0.095      0.325        0.356       0.024       0.026       0.024       0.026

for local soil (mg/kgdwt)              0.053       0.004      0.198        0.016       0.015       0.001       0.016       0.001

Man via environment, combined routes       n.a.       0.024        n.a.                0.145       n.a.       < 0.01       n.a.       0.0002

ERC2 = Formulation of preparations

ERC5 = Industrial use resulting in inclusion into or onto a matrix

ERC8d = Wide dispersive outdoor use of processing aids in open systems

ERC10b = Wide dispersive outdoor use of long-life articles and materials with high or intended release (including abrasive processing)

Notes:

•       PNECs for local freshwater sediment and local marine sediments were estimated by the equilibrium partitioning method with

Koc = 1235 liter/kg (from Episuite 4.1, lowest value, from log Kow and KOCWIN v2.00)

•       From this environmental exposure modelling it must be concluded that care should be taken to prevent 2,4-dihydroxybenzophenone

from entering the aqueous and sediment compartments.

•       ERC8d also covers ERC8a (wide dispersive indoor use).

•       ERC10b also covers ERC10a (outdoor, low release), ERC11b (indoor, high or intended release) and ERC11a (indoor, low release)

•       Water hazard classification according to the German VwVwS: WGK 2 (dangerous)

•       All ERCs have a municipal sewage treatment plant (STP) with 13.24 % efficiency

•       All ERCs have on-site air scrubbing with an efficiency of 90% and water treatment with an efficiency of 99%

Stability and reactivity

See also attached safety data sheet

10.1       Reactivity:       Product is stable under normal storage and usage conditions

             

10.2       Chemical stability:       The product is stable

             

10.3       Possibility of hazardous reactions:       None

             

10.4       Conditions to Avoid:       Extreme temperatures

             

10.5       Incompatible materials:       Strong oxidising agents, strong acids, strong bases

             

10.6       Hazardous decomposition products:       May create COx on thermal decomposition

Disposal considerations

See also attached safety data sheet

13.1       Waste treatment methods:       GENERAL

Must not be disposed of together with household garbage. Treat as chemical waste. Do not allow product to reach sewer system. Contact manufacturer for recycling information.

UNCLEANED PACKAGINGS - RECOMMENDATION

Must be disposed of according to official regulations

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