Registration Dossier

Administrative data

First-aid measures

INHALATION
Move the exposed person to fresh air at once. Get medical attention.

INGESTION
Wash out mouth with water, provided person is conscious. Get medical attention.

SKIN CONTACT
Remove contaminated clothing and wash skin with soap and plenty of running water. Get medical attention.

EYE CONTACT
Causes serious eye damage. Rinse immediately eye with plenty of low pressure water for at least 15 minutes.
Remove any contact lenses. Get medical attention.

Fire-fighting measures

EXTINGUISHING MEDIA
Flashpoint 96 °C (closed cup)
To extinguish fire use water spray, dry powder, carbon dioxide, or foam.

SPECIAL FIRE FIGHTING PROCEDURES
Prevent run-off water from entering the sewer system.

UNUSUAL FIRE & EXPLOSION HAZARDS
None.

SPECIFIC HAZARDS
By fire toxic gases may be formed (Cox, NOx, SOx, POx).

PROTECTIVE MEASURES IN FIRE
Self contained breathing apparatus and full protective clothing.

Accidental release measures

PERSONAL PRECAUTIONS
See below

ENVIRONMENTAL PRECAUTIONS
Take precautionary measures against discharges into the environment.

SPILL CLEAN UP METHODS
Collect spilled material without creating dust, then place into a suitable closed container for disposal as chemical waste.

Handling and storage

USAGE PRECAUTIONS
Avoid contact with eyes or skin.
Wash thoroughly after handling and before eating, drinking or smoking.

STORAGE PRECAUTIONS
To protect product quality, store in sealed container in a cool place and out of direct sunlight.

Transport information

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Marine transport (IMDG)

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Exposure controls / personal protection

EXPOSURE LIMITS
None listed.

USE LIMITS
The substance is a urease inhibitor which can reduce nitrogen loss by ammonia volatilisation from urea. It is used as a fertiliser additive in agricultural applications.

PNECs:
aqua-freshwater: 0.28 mg/L
aqua-marine water: 0.028 mg/L
aqua-intermittent: 2.8 mg/L
sewage treatment plant: 184 mg/L
sediment-freshwater: 1.05 mg /kg dw
sediment-marine water: 0.105 mg /kg dw
soil: 5.06 mg /kg dw

DNELs:
The main derived long-term DNELs for systemic effects are:
Workers General population
Oral not relevant 0.085 mg/kg bw/day
Dermal 0.17 mg/kg bw/day 0.085 mg/kg bw/day
Inhalation 0.15 mg/m3/day 0.037 mg/m3/day

INDUSTRIAL WORKERS TOXICITY

The ECETOC TRAM Worker Tool version3 (of 10 April 2012), exposure model for this substance shows for
• indoor industrial activities at ambient temperatures
• with an advanced occupational health and safety system
• taking more than 4 hours/day
• with local exhaust ventilation (LEV) present (and running)
• and gloves with at least 95% dermal protection

the following long term systemic exposures:

Inhalation (mg/m3) dermal (mg/kg/day) RCR (inh) RCR (dermal) RCR (total)
PROC1 7.00e-3 2.00e-3 0.047 0.01 0.057
Use in closed process, no likelihood of exposure
PROC2 7.00e-4 7.00e-3 0.005 0.04 0.045
Use in closed, continuous process with occasional controlled exposure
PROC3 7.00e-3 3.00e-3 0.047 0.02 0.067
Use in closed batch process (synthesis or formulation)
PROC4 3.50e-2 3.40e-2 0.233 0.202 0.435
Use in batch and other process (synthesis) where opportunity for exposure arises
PROC5 3.50e-2 6.90e-2 0.233 0.403 0.637
Mixing or blending in batch processes for formulation of preparations and articles (multistage and/or significant contact)
PROC8a 3.50e-2 6.90e-2 0.233 0.403 0.637
Transfer of substance or preparation (charg-ing/discharging) from/to vessels/large containers at non-dedicated facilities
PROC8b 3.50e-3 3.40e-2 0.023 0.202 0.225
Transfer of chemicals from/to vessels/large containers at dedicated facilities
PROC9 7.00e-3 3.40e-2 0.047 0.202 0.248
Transfer of chemicals into small containers (dedicated filling line)
PROC14 7.00e-3 1.70e-2 0.047 0.101 0.148
Production of preparations or articles by tabletting, compression, extrusion, pelletisation
PROC15 7.00e-3 2.00e-3 0.047 0.01 0.057
Use of laboratory reagents in small scale laboratories

Notes:
• The outcome of ECETOC TRAM v3 (10 April 2012) is identical to CHESAR v2.1.0
• 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 PROC1 LEV is not an exposure modifier
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%


PROFESSIONALWORKERS TOXICITY

The ECETOC TRAM Worker Tool version3 (of 10 April 2012), exposure model for this substance shows for
• outdoor professional activities at ambient temperatures
• with a basic occupational health and safety system
• taking more than 4 hours/day
• The concentration of the substance in the final fertiliser mix is below 1%
• provided workers wear masks with at least 90% respiratory protection
• and gloves with at least 90% dermal protection

the following long term systemic exposures:

Inhalation (mg/m3) dermal (mg/kg/day) RCR (inh) RCR (dermal) RCR (total)
PROC8a 0.003 0.137 0.023 0.806 0.829
Transfer of substance or preparation (charging/discharging) from/to vessels/large containers at non-dedicated facilities

Notes:
• The outcome of ECETOC TRAM v3 (10 April 2012) is identical to CHESAR v2.1.0
• Dustiness of the substance was set at “low”

MAN VIA THE ENVIRONMENT

The same CHESAR tool predicts the following for the relevant ERC2 (at 1000 t/y per site; 10 t/d per site), ERC4 (at 180 t/y per site; 0.5 t/d per site) and ERC8d (at 1000 t/y) with fraction of tonnage to region = 1:
Total daily intake man via the environment regional: RCR = 0.080 (ERC2) / 0.581 (ERC4) / 0.013 (ERC8d) / 0.024 (combined environmental assessment)
ERC2 = Formulation of preparations
ERC4 = Industrial use of processing aids in processes and products, not becoming part of articles
ERC8d = Wide dispersive outdoor use of processing aids in open systems


CONSUMER TOXICITY

The ECETOC TRAM Consumer Tool version3 (of 10 April 2012), exposure model for this substance shows for
• Adult consumer activities
• With one hand exposed to the final product (428.75 cm2)
• With the default oral and dermal transfer factors of 1
• While the concentration of the substance in the final fertiliser mix is below 0.064%

the following long term systemic exposures:
Maximal concentration Dermal Oral RCR RCR RCR
of NBPT in final exposure exposure dermal oral total
product in % mg/kg/d mg/kg/d
PC12 0.064 4.57e-2 1.92e-2 0.538 0.226 0.764
Fertilisers (lawn and garden preparations)

PROTECTIVE EQUIPMENT
Protective gloves, safety goggles, breathing apparatus and protective clothing.

MAXIMUM CONCENTRATION OF SUBSTANCE IN A MIXTURE
In a professional environment the substance is only to be used in a mixture with less than 1%.
In a consumer environment the substance is only to be used in a mixture with less than 0.064%.

RESPIRATORY EQUIPMENT
In a professional environment: Breathing apparatus: Wear positive pressure self-contained breathing apparatus classified under EN137 : 2006 with at least 90% respiratory protection.

HAND PROTECTION
Protective gloves: Use chemical resistant gloves classified under Standard EN374, class 5.
In an industrial environment: give operators specific training.
In a professional environment: with basic employee training.

EYE PROTECTION
Wear approved safety goggles.

HYGIENE MEASURES
Wash at the end of each work shift and before eating, drinking, smoking or using the toilet.

SKIN PROTECTION
Wear protective clothing.

ECOTOXICITY

LC50 (sweet water fish toxicity, 96h) 1140 mg/l
Chronic value (NOEC, SW fish) 544 mg/l (calculated)

EC50 (Daphnia immobilisation, 48h) 290 mg/l
Chronic value (NOEC, 21d, Daphnia) 455 mg/l (calculated)

EC50 (algae growth rate, 96h) 280 mg/l (calculated)

NOEC (STP) 1840 mg/l (calculated
LC50 (Earthworm, 14d) 506 mg/kg dw (calculated)

The same CHESAR v2.1.0 tool predicts the following for the relevant ERC2 (at 1000 t/y per site; 10 t/d per site), ERC4 (at 180 t/y per site; 0.5 t/d per site) and ERC8d (at 1000 t/y) with fraction of tonnage to region = 1:

ERC2 ERC4 ERC8d
PEC RCR PEC RCR PEC RCR
for local freshwater (mg/L) 0.104 0.371 0.254 0.907 0.032 0.113
for local freshwater sediment (mg/kgdwt) 0.419 0.399 1.024 0.975 0.127 0.121
for local marine water (mg/L) 0.01 0.371 0.025 0.906 0.003 0.112
for local marine sediments (mg/kgdwt) 0.042 0.398 0.102 0.974 0.013 0.120
in STP (mg/L) 0.999 0.005 2.499 0.014 0.275 0.001
for local soil (mg/kgdwt) 0.002 <0.01 0.005 <0.01 5.029e-4 <0.01

ERC2 = Formulation of preparations
ERC4 = Industrial use of processing aids in processes and products, not becoming part of articles
ERC8d = Wide dispersive outdoor use of processing aids in open systems
Notes:
• PNECs for local freshwater sediment and local marine sediments were estimated by the equilibrium partitioning method with Koc = 4.311 liter/kg (from Episuite 4.1)
• All ERCs have a sewage treatment plant (STP) with 0.056 % efficiency. In addition ERC2 and ERC4 have filtration and scrubbing with 99% efficiency.

PBT / vPvB ASSESSMENT
The substance is not a PBT or a vPvB substance and is inherently biodegradable.

EMISSION CHARACTERISATION
From various estimates as calculated with the Episuite models (Epiweb v4.1) there is no reason to assume that this substance will have an influence on global warming, ozone depletion in the stratosphere, ozone formation in the troposphere, acidification, etc.

WATER HAZARD CLASSIFICATION
According to the German VwVwS: None.

Stability and reactivity

STABILITY
Stable under normal temperature conditions and recommended use.

MATERIALS TO AVOID
Strong oxidising agents, strong acids, strong bases

HAZARDOUS DECOMPOSITION PRODUCTS
By fire toxic gases (Cox, NOx, SOx, POx) may be formed

Disposal considerations

GENERAL INFORMATION
Place into a suitable closed container for disposal as chemical waste.

DISPOSAL METHODS
Dispose of in accordance with local and national regulations.