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EC number: 480-680-7 | CAS number: 120128-90-7
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07. Jun. 2005 - 14. Jun. 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 480-680-7
- EC Name:
- -
- Cas Number:
- 120128-90-7
- Molecular formula:
- Hill formula: C8H16N2O3 CAS formula: C8H16N2O3
- IUPAC Name:
- 480-680-7
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Species: rabbit
Breed: New Zealand White, IVA: NZW
Breeder: Charles River, Extertal, Germany
Date of receipt: 2005-05-31
Sex: 1 male and 2 female
Number: a total of 3
Body weights: 1793.3 g, 1807.7 g, 1988.1 g
Age: - 10 weeks
Identification: dyemarks and cage numbers
Diet: Altromin International, Lage, Germany, 2023 - 1518
Water: Normal tap water from municipal sources Stadtische Werke Krefeld AG, Krefeld, Germany, was offered. The water is monthly examined for pollutants which might interfere with the study. The data are retained in the archive. The water was supplied to the animals ad libitum via drinking bottles with rubber stoppers and steel pipes.
Husbandry: The rabbits were housed single in steel cages with a plastic bottom mould and a habitat of 5445 square cm2 at the bottom and an overall height of 600 mm. A non-barrier system with air conditioning was used. The air conditioning had the fol/owing nominal values: Temperature: 20 ± 3°C, Humidity: 30 - 70 %. Climate control was run automatically. Temperature and humidity were measured continuously using a thermohygrometer from Lambrecht GmbH, Gottingen, Germany. The data were archived. There have been no deviations from nominal temperature and humidity values during the experiment.
Bedding material: Lignocel BK 10/20, Rettenmaier & Stihne GmbH & Co., Ellwangen-Holzmuhle, Germany.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL of test substance into the right eye of each animal.
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- Examination of the treated eyes was carried out 1 hour and approximately 24, 48, 72 hours and 7 days after application of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Before the experiment was started, the animals were clearly marked with dye and weighed. Food and drinking water was left for the animals ad libitum.
Body weight was recorded immediately before test substance application and at the final observation 7 days later. The evaluation of the existing animal and in vitro studies revealed that the test substance is not corrosive or severely irritant. However, due to animal welfare reasons an initial test using one animal was performed. The test substance was applied into the right eye by pulling the lower eyelid away from the
eyeball to form a cup into which 0.1 ml of the test material was sprinkled in. The eyelid was gently held together for one second and then released. The left eye remained untreated and served as a control. As no corrosive or strong irritating effect was observed within one hour after application further two animals were treated in the same way. Examinations of ocular reactions were facilitated without any device. After recording the observations at 24 hours, the eyes of a\l rabbits were further examined with the aid of fluorescein to look for damage of the cornea. One drop of a 0.5 % (w/v) Fluorescein solution in saline solution was poured into both eyes and washed off with saline solution 30 seconds later. Afterwards scoring was executed by use of an UV-light lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: slight ocular reactions 1 h after application of the test substance
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Ocular Lesions:
Animal No. 504 LV |
1h |
24h |
48h |
72h |
7d |
Mean (24-72h) |
|
1. Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0.00 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0.00 |
2 Iris |
A |
0 |
0 |
0 |
0 |
0 |
0.00 |
3 Conjunctivae redness |
A |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae chemosis |
B |
1 |
1 |
0 |
0 |
0 |
0.33 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0.00 |
Animal No. 505 RV |
1h |
24h |
48h |
72h |
7d |
Mean (24-72h) |
|
1. Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0.00 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0.00 |
2 Iris |
A |
0 |
0 |
0 |
0 |
0 |
0.00 |
3 Conjunctivae redness |
A |
1 |
0 |
0 |
0 |
0 |
0.00 |
Conjunctivae chemosis |
B |
2 |
0 |
0 |
0 |
0 |
0.00 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0.00 |
Animal No. 507 LH |
1h |
24h |
48h |
72h |
7d |
Mean (24-72h) |
|
1. Cornea opacity |
A |
0 |
0 |
0 |
0 |
0 |
0.00 |
Cornea area |
B |
0 |
0 |
0 |
0 |
0 |
0.00 |
2 Iris |
A |
0 |
0 |
0 |
0 |
0 |
0.00 |
3 Conjunctivae redness |
A |
1 |
0 |
0 |
0 |
0 |
0.00 |
Conjunctivae chemosis |
B |
1 |
0 |
0 |
0 |
0 |
0.00 |
Conjunctivae discharge |
C |
1 |
0 |
0 |
0 |
0 |
0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- The test results indicate a no eye irritation potential of the test substance Formamidopropyldimethylbetain 50 %ig to eyes and mucous membranes. All 3 animals showed slight ocular reactions 1 h after application of the test substance. 48 hours after application all three animals were without any sign of ocular irritation. The mean grades of reactions at 24, 48 and 72 h reading correspond to values classified as not irritant by the Directive 67/548/EEC as well as GHS Regulation EC No 1272/2008.
- Executive summary:
For labelling and classification purposes the test substance Formamidopropyldimethylbetain 50 %ig was tested regarding its irritation potential towards eyes and adjacent mucous membranes of experimental animals. The potential to cause damage to the conjunctivae, iris and cornea was assessed by single application of the test substance into the lower conjunctival sac of the eyes of two female and one male rabbit, strain New Zealand White, according to the OECD Guideline for the Testing of Chemicals 405 "Acute Eye Irritation/Corrosion". Due to animal welfare reasons an initial test using one animal was performed. 0.1 ml of the test substance was applied to the eye of one animal. As no corrosive or strong irritating effect was observed within one hour after application further two animals were treated in the same way. Ocular reactions were assessed 1, 24, 48, 72 hours and 7 days after application of the test substance. At 24 hours post application the eyes of all animals were further examined with fluorescein to look for cornea damage. Systemic toxic symptoms after application were not observed at any time during the study. Body weight development was positive and within normal ranges. All 3 animals showed slight ocular reaction (conjunctivae redness 1 score, conjunctivae chemosis 1 or 2 scores and conjunctivae discharge 1 score) 1 h after application of the test substance. In one animal a slight conjunctivae redness and chemosis was still observed 24 h after application. 24 hours later (48 h after application) all three animals were without any sign of ocular irritation. Cornea damage or iris irritation was not observed at any time during the study. The Primary Irritation Index for the test substance Formamidopropyldimethylbetain 50 %ig was calculated to be "8" from "110" total possible scores at 1 h post application. Under the conditions of this study the test substance Formamidopropyldimethylbetain 50 %ig was graded as non-irritating to eyes and mucous membranes according to the Primary Irritation Index.
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