Registration Dossier

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 (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