Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 843-143-1 | CAS number: 709647-81-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 01 April 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Detail on test item is not clear
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: The Hen's Egg Test- Utilizing the Chorioallantonic Membrane (HET-CAM)
- Version / remarks:
- Kemper & Luepke
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- L-Arginine, N2-(2,3-dihydroxypropyl)-, monohydrochloride
- EC Number:
- 843-143-1
- Cas Number:
- 709647-81-4
- Molecular formula:
- C9H21ClN4O4
- IUPAC Name:
- L-Arginine, N2-(2,3-dihydroxypropyl)-, monohydrochloride
- Test material form:
- liquid
- Remarks:
- Test item 15 % in distilled water
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL: Not specified
- Source and lot/batch No. of test material:
- Expiration date of the lot/batch:
- Purity test date:
RADIOLABELLING INFORMATION (if applicable): N/A
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: Not specified
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING: Applied diluted
- Treatment of test material prior to testing: diluted to 15% in distilled water
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material):N/A
TYPE OF BIOCIDE/PESTICIDE FORMULATION (if applicable): N/A
OTHER SPECIFICS: N/A
- measurement of pH, osmolality, and precipitate in the culture medium to which the test chemical is
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: White Leghorn
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EGGS
- Source: Moyer’s Chicks, Inc. Quakertown Pennsylvania
- Number of eggs: Not specified
- Characteristics of donor animals (e.g. age, sex, weight): Not specified
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Fresh eggs stored in test facility up 7 days at 500 F, the eggs were incubated in a Kuhl incubator which rotated automatically once every hour. Incubation temperature was controlled at 990 F (+/- 10 F) with relative humidity of 60 – 70% for the 10 days of incubation. On day 8, the eggs were turned so that the acutely angled end faced down. On day 10 the eggs were removed from the incubator and placed in preheated and humidified Plexigals work encloser.
Test system
- Vehicle:
- water
- Remarks:
- Distilled water
- Controls:
- other: Nivea moisturing lotion 50% and vaseline dermatology formula lotion 50%
- Amount / concentration applied:
- 0.3 ml
- Duration of treatment / exposure:
- 20 seconds
- Observation period (in vivo):
- 30 seconds, 2 and 5 minutes
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- 4 CAMs
- Details on study design:
- Fresh eggs stored in test facility up 7 days at 500 F, the eggs were incubated in a Kuhl incubator which rotated automatically once every hour. Incubation temperature was controlled at 990 F (+/- 10 F) with relative humidity of 60 – 70 % for the 10 days of incubation. On day 8, the eggs were turned so that the acutely angled end faced down. On day 10 the eggs were removed from the incubator and placed in preheated and humidified Plexigals work encloser. Forceps were then used to remove the shell down to the shell-membrane junction. The inner egg membrane was then hydrated with a warm, physiological saline solution. The saline was removed after 2 – 5 minutes exposure. Utilizing point forceps, the inner egg membrane was then carefully removed to reveal the CAM.
The test or reference article, at a dosage of three-tenth of one millilitre (0.3ml) of liquid was administered to each of four CAM’s. Twenty second later, the test or control article was rinsed from each CAM with 5 ml of physiological saline. All CAMs were observed immediately prior to test article administration, at 30 seconds, 2 and 5 minutes after exposure to the test article. The reaction of the CAM, the blood vessels, including the capillaries, and the albumin were examined and score for initiation effects as detailed below.
Effects score
Time (min) 0.5 2 5
Hyperemia 5 3 1
Minimal Haemorrhage (‘Feathering) 7 5 3
Haemorrhage (Obvious Leakage) 9 7 5
Coagulation and/or Thrombosis 11 9 7
The numerical, time dependant scores were tolerated for each CAM. Each reaction type can be recorded only once for each CAM, therefore the maximum score per CAM is 32. The mean score was determined for all CAM’s similarly tested.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 1.75
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The reference substances have historically been categorised as being practically non-irritating, eliciting score approaching 0, at 24 hours, when dosed at 100% and tested using Draize occular irritation methodologies (Draize Scale: 0 - 110). At 50%, the score of 1.00 and 2.00 all within the acceptability range.
Any other information on results incl. tables
Table 3. Experimental scoring results for irritation
Test Group |
CAM # |
Score@ |
|||
0.5 min. |
2 min. |
5 min. |
Total |
||
N-Glyceryl Arginine HCL (15% in distilled water) |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
1 |
1 |
|
3 |
0 |
3 |
0 |
3 |
|
4 |
0 |
3 |
0 |
3 Average: 1.75 |
|
Nivea Moisturizing Lotion (50%) |
1 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
1 |
1 |
|
3 |
0 |
0 |
1 |
1 |
|
4 |
0 |
0 |
1 |
1 Average: 1.00 |
|
Vaseline Dermatology Formula Lotion (50%) |
1 |
0 |
0 |
1 |
1 |
2 |
0 |
0 |
1 |
1 |
|
3 |
5 |
0 |
0 |
5 |
|
4 |
0 |
0 |
1 |
1 Average: 2.00 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test article was not considered an occular irritant
- Executive summary:
The test or reference article, at a dosage of three-tenth of one millilitre (0.3ml) of liquid was administered to each of four CAM’s. Twenty seconds later, the test or control article was rinsed from each CAM with 5 ml of physiological saline. All CAMs were observed immediately prior to test article administration, at 30 seconds, 2 and 5 minutes after exposure to the test article. The reaction of the CAM, the blood vessels, including the capillaries, and the albumin were examined and score for initiation effects.
The numerical, time dependant scores were tolerated for each CAM. Each reaction type can be recorded only once for each CAM, therefore the maximum score per CAM is 32. The mean score was determined for all CAM’s similarly tested.
The reference substances have historically been categorised as being practically non-irritating, eliciting score approaching 0, at 24 hours, when dosed at 100% and tested using Draized ocular irritation methodologies (Draize Scale: 0 - 110). at 50%, the score of 1.00 and 2.00 all within the acceptability range.
The average score for the test article was 1.75, falling within the classification for no irritation. Under the condition of the study, the results indicate that N-Glyceryl Arginine HCl, at 30%, would have practically no occular irritation potential in vivo.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.