Milicard

L-ARGININE HCL

1.2.1 -Milicard number : 110.239.009

1.2.2 -EA Codex number : 89-4005-2021

1.2.3 -Cas number : 74-79-3

1.2.4 -EC number : 200-811-1

1.2.5 -Permit License number : 200-811-1

1.2.6 -Patent and License number : 200-811-1

1.4.1-CHEMICAL FORMULA : C6H14N4O2
1.4.2-TYPE/STATE/FORM  : Crystal
1.4.3-COLOUR  : White
1.4.4-ODOUR : Odorless
1.4.5-TASTE : Bitter
1.4.6-PARTICLE SIZE  : D10:11.16µm, D50=56.59µm, D90=158.83µm
  The fraction <10 µm was determined to be ca.  % 8.8 by volume
1.4.7-DENSITY : 1.46 g/cm³, Bulk: 640 kg/m³
1.4.8-MELTING POINT  : 223°C
1.4.9-BOILING POINT : 368°C
1.4.10-FLASH POINT  : 176.1±30.7 °C
1.4.11-VAPOUR PRESSURE : < 0,1 Pa nin 25 °C
1.4.12-VISCOSITY : Not available
1.4.13-REFRACTIVE IDEX : Not available
1.4.14-IGNITION TEMP : Not available
1.4.15-DISSOCIATION CONSTANTS : 2.17 at 20 °C
1.4.16-SOLUBILITY : Soluble in H2O 182 g/L at 25 °C
1.4.17-pH VALUE : 11.4 (100 g/L ,H2O,20 °C)
1.4.18-ACIDITY pKa : 2.24
1.4.19-Log P : log P :-4.20
1.4.20-CHIRAL ROTATION  : [α]20/D +27°, c = 8, 6 M HCl’de
1.4.21-MOLAR MASS : 174.2 g/mol
1.4.22-PURIFY :  % 98
1.4.22.1-CARRIER  : Metal Ion
1.4.23-METALS : Chloride <%0,02,Sulphate <%0.01 Heavy Metals <%0.0001 Arsenic <%0.00001
  Calcium <%0.001 Cobalt< %0.000001 Fe <%0.0005 K <%0.0003 Mg <%0.0002
  Amonium N<%0.01 Na <%0.01
1.4.24-LD 50 ORAL RAT : > 5110 mg/kg
1.4.25-GHS  : H315 (% 15.35): Causes skin irritation
  H319 (% 99.6): Causes serious eye irritation
1.4.26-WGK : Not available
1.4.27-OTHER DETAILS  : Not available
Product Name: L-ARGININE
Producer Name: Fermo Crysta™ Fermantasyon Kristalleri Üretim Gıda San. Ve Tic. LTD. ŞTİ.
    Saray Osmangazi Mahallesi Sarsılmaz Cad.No: 2/15 Pursaklar/ANKARA 0312 5143724
MILICARD NO 
CODEX NUMBER 
CAS NUMBER: 74-79-3

Acil durum telefon numarası Ulusal Zehir Danışma Merkezi (UZEM):

114 CHEMTREC Turkey (Istanbul): +(90)-212-7055340

Toxicological Data on Ingredients: L-Arginine LD50: >5.110mg/kg. LC50: = Not available.
Potential Acute Health Effects: Slightly hazardous in case of skin contact, of eye contact (irritant), of ingestion, of inhalation.
Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not . MUTAGENIC EFFECTS: Mutagenic for mammalian somatic CELLS
TERATOGENIC EFFECTS: Not  DEVELOPMENTAL TOXICITY: Not. Prolonged exposure is not known to aggravate medical condition.
GHS.Warning,Eye,Irritation,Category 2,H319,P305,P351,P338

EyeContact: Check for and remove any contact lenses. In case of contact,immediately flush eyes with plenty of water for at least 
15 minutes Cold water may be used. Get medical attention if irritation occurs.
Skin Contact: Wash with soap and water. Cover the irritated skin with an emollient. Get medical attention if irritation develops.
Cold water may be used.
Serious Skin Contact: Not available.
Inhalation: If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen.
Serious Inhalation: Not available.
Ingestion: DoNOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an 
unconscious  person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight clothing
such as a collar, tie,belt or waistband.
Serious Ingestion: Not available.

Flammability of the Product: May be combustible at high temperature.
Auto-Ignition Temperature: Not available.
Flammable Limits: Not available.
Products of Combustion: These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2…).
Fire Hazards in Presence of Various Substances: Slightly flammable to flammable in presence of heat. Non-flammable in 
presence of shocks.
Explosion Hazards in Presence of Various Substances: Risks of explosion of the product in presence of mechanical impact: Not 
Risks of explosion of the product in presence of static discharge: Not available.
Fire Fighting Media and Instructions: SMALL FIRE: Use DRY chemical powder. LARGE FIRE: Use water spray, fog or foam. 
Do Not Use  water jet.
Special Remarks on Fire Hazards: Not available.
Special Remarks on Explosion Hazards: Not available.

Small Spill: Use appropriate tools to put the spilled solid in a convenient waste disposal container.Finish cleaning by 
spreading water on the contaminated surface and dispose of according to local and regional authority requirements.
Large Spill: Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water 
on the contaminated surface and allow to evacuate through the sanitary system.

Regulation (EU) No. 1907/2006  ( regulation on Safety Data Sheets for Hazardous Substances and Mixtures  
(R.G 13.12.2014-29204) Preparation Date:12.09.2019 New Arrangemet Date:19.09.2020
Precautions: Keep locked up.. Keep away from heat. Keep away from sources of ignition. Empty containers pose a fire risk,
evaporate the residue under a fume hood. Ground all equipment containing material. Do not breathe dust. Wear suitable
protective clothing.
If you feel unwell, seek medical attention ,show thelabel when possible.Keepaway from incompatibles such as oxidizing agents.
Storage: Light sensitive. Store in light resistant containers. Keep container tightly closed. Keep container in a cool, 
well-ventilated area.
Do not store above 24°C (75.2°F).

Engineering Controls: Use process enclosures, local exhaust ventilation,other engineering controls to keep airborne levels 
below recommended exposure limits.
If user operations generate dust, fume,mist, use ventilation to keep exposure to airborne contaminants below the exposure 
limit.
Personal Protection: Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent.
Gloves.
PersonalProtection in Case of a LargeSpill:Splash goggles.Full suit.Dust respirator. Boots. Gloves. A self contained breathing 
apparatus should be used to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a 
specialist BEFORE handling this product.
Exposure Limits: Not available.

Physical state and appearance : Solid. (Crystalline)
Chemical Formula : C6H14N4O2
Odor : Odorless
Taste : Not availabe
Molecular Weight : 174.2 g/mol
Cas Number : 74-79-3
EC Number : 200-811-1
Melting Point : 223°C (433°F)
Color : White
Dispersion Properties : See solubility in water.
Solubility : Soluble in cold water, hot water. Insoluble in diethyl ether. Sparingly soluble in alcohol

Stability: The product is stable.
Instability Temperature: Not available.
Conditions of Instability: Excess heat, light
Incompatibility with various substances: Reactive with oxidizing agents.
Corrosivity: Non-corrosive in presence of glass.
Special Remarks on Reactivity: Light sensitive.
Special Remarks on Corrosivity: Not available.
Polymerization: Will not occur.

4.1.10.1-Acute toxicity
LD50 Oral – Rat – male and female – > 5.110 mg/kg Remarks: (ECHA)
Inhalation: No data available
Dermal: No data available
4.1.10.2-Skin corrosion/irritation
Skin – Rabbit
Result: No skin irritation – 4 h (OECD Test Guideline 404)
4.1.10.3-Serious eye damage/eye irritation
Eyes – Rabbit
Result: No eye irritation – 1 h (OECD Test Guideline 405)
4.1.10.4-Respiratory or skin sensitization
No data available
4.1.10.5-Germ cell mutagenicity
Test Type: Mutagenicity (mammal cell test): chromosome aberration. Test system: Human lymphocytes
Metabolic activation: with and without metabolic activation Method: OECD Test Guideline 473
Result: negative
Test Type: Ames test
Test system: Escherichia coli/Salmonella typhimurium Metabolic activation: with and without metabolic activation 
Method: OECD Test Guideline 471 Result: negative
4.1.10.6-Carcinogenicity
No data available
4.1.10.7-Reproductive toxicity
No data available
4.1.10.8-Specific target organ toxicity – single exposure
No data available
4.1.10.9-Specific target organ toxicity – repeated exposure
No data available
4.1.10.10-Aspiration hazard
No data available

Ecotoxicity: Not available.
BOD5 and COD: Not available.
ProductsofBiodegradation:Possibly hazardous shortterm degradation products are not likely.
However, longterm degradation products may arise.
Toxicity of the Products of Biodegradation: The product itself and its products of degradation are not toxic.
Special Remarks on the Products of Biodegradation: Not available.
The test results for acute toxicity of L-arginine to fish were: LC50 = 2.8 g/L; LC 100 = 5.6 g/L;
NOEC (mortality) = 1.8 g/L; NOEC (condition) = 1.0 g/L.

Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations.
Identification: Not applicable.

Land Transport(ADR/RID): According to transportation rules, it is not classified as dangerous goods.
Weather Transport(IATA): According to transportation rules, it is not classified as dangerous goods.
Sea Transport (IMDG): According to transportation rules, it is not classified as dangerous goods.

1907/2006 certificate  for this product A chemical safety assesment in accordance with  EU REACH Regulition   
Storage class  10 – 13
EINECS: This product is on the European Inventory of Existing Commercial Chemical Substances.
DSCL (EEC): R40- Possible risks of irreversible effects. S2- Keep out of the reach of children. 
S36/37- Wear suitable protective clothing and gloves.
Health Hazard: 1
Fire Hazard: 1
Reactivity: 0
Personal Protection: E
National Fire Protection Association (U.S.A.):
Health: 1
Flammability: 1
Reactivity: 0
Specific hazard:
Protective Equipment: Gloves. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. 

Toxicological Data on Ingredients: L-Arginine LD50: >5.110mg/kg. LC50: = Not available.
Potential Acute Health Effects: Slightly hazardous in case of skin contact, of eye contact (irritant), of ingestion, of inhalation.
Potential Chronic Health Effects: CARCINOGENIC EFFECTS: Not . MUTAGENIC EFFECTS: Mutagenic for mammalian somatic CELLS
TERATOGENIC EFFECTS: Not  DEVELOPMENTAL TOXICITY: Not. Prolonged exposure is not known to aggravate medical condition.
GHS.Warning,Eye,Irritation,Category 2,H319,P305,P351,P338

4.2.2.1-Toxicity
A limit test according to OECD 203 did not show any adverse effects to fish at a test concentration of 1 g/L L-arginine.
A subsequent test with L-arginine according to OECD 203 with higher test concentrations showed the following results:
LC50 = 2.8 g/L; LC 100 = 5.6 g/L; NOEC (mortality) = 1.8 g/L; NOEC (condition) = 1.0 g/L.
EC50 was found to be 1.8g/L,EC100 was found to be 5.6 g/L. EC50 for algae was calculated to be ca. 26857mg/L
NOEC(mobility)was estimated to be 1.0 g/L and NOEC (condition)was estimated to be <1.0g/L
L-arginine did not show toxicity to mikroorganisms. The EC10 after 16h was>10g/L
Considering the results from higher trophic levels as well as for microorganisms and an expert statement
(see endpoint summary in IUCLID section 6.1.5) toxicity testing with aquatic algae was not deemed necessary.
Fresh water fish :limit test according to OECD 203 did not show any adverse effects to fish at a test concentration of 1 g/L
Fresh water invertebrates:A limit test according to OECD 202 did not show any adverse effects to Daphnia magna at a test
concentration of 1 g/L L-arginine.
A subsequent test with L-arginine according to OECD 202 with higher test concentrations showed the following results:
EC50 = 1.8 g/L; EC100 = 5.6 g/L; NOEC (mobility) was estimated to be 1.0 g/L and NOEC (condition) was estimated to be < 1.0 g/L.


4.2.2.2-Irratıon-Corrosion
The instillation of L-arginine did not cause any changes at the rabbits eyes. The corneae, irises and conjunctivae were not affected
by instillation of the test item. L-arginine is classified as not-irritating to eyes.


4.2.2.3- Sensitation
There is no human or animal data that indicates L-arginine to be a skin sensitiser. Considering the extensive, widespread dermal
exposure to L-arginine in preparations repeatedly applied to the skin or being in contact with the skin, the absence of case reports
of humans showing skin reactions is consistent with L-arginine having a very low skin sensitisation potential.


4.2.2.4- Repeated dose toxicity
The mean human daily intake of arginine for all life stage and gender groups from food and supplements is approximately 4.2 g/d
(Food and Nutrition Board, 2005). A dietary dose of 5.0% L-arginine is equivalent to about 50 times amount of the mean daily
oral intake for humans.


4.2.2.5- Genetic Toxicity
In a GLP guideline study according to OECD 473 L-arginine did not induce a statistically significant increase in the
frequency of cellswith chromosome aberrations in either the absence or presence of a liver enzyme metabolising system in
either of two separate experiments. The maximum test concentration was 1740 µg/L. The test material was therefore considered
to be non-clastogenic to human lymphocytes in vitro.

4.2.2.6-Toxicity to Reproduction
L-arginine did not show effects on the reproductive organs in general repeated dose toxicity studies. Moreover, L-arginine
is an amino acid that is required for normal functioning of humans. The substance is of very low toxicological activity and
subject to homeostasis. Therefore, reprotoxic effects are not expected for L-arginine and no test is required for this
substance.