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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09. May 2005 - 17. May 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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal 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
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: rabbit
Breed: New Zealand White, IVA: NZW
Breeder: Charles River, Extertal, Germany
Date of receipt: 2005-05-03
Sex: 1 male and 2 female
Body weights: 1805.3 g, 1905.8 g, 1949.1 g
Age: - 10 weeks
Identification: dyemarks and cage numbers
Diet: Altromin International, Lage, Germany, 2023 - 1425
Water: Drinking water for the animals consisted of normal tap water from municipal sources: Stadtische Werke Krefeld AG, Abt. 2 TGW, Krefeld, Germany. The composition of the water is regularly determined. 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.
Bedding material: Lignocel BK 10/20, Rettenmaier, Jagstzell, Germany
Husbandry: They were housed single in steel cages with a plastic bottom mould and a habitat of 5445 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 following nominal values: Temperature: 20 ± 3 °C, Humidity: 30 -70 %. Climate control was run automatically. The lightening was in a 12-hour light/dark-cycle. Temperature and humidity were recorded continuously using a thermohygrometer, Lambrecht GmbH, Gottingen, Germany. The data were archived. There have been no deviations from nominal temperature and humidity values during the experiment.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 ml of the test substance was applied to the left flank
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Examination of the treated skin sites was done 1 hour, and approximately 24, 48, 72 hours as well as 7 days after removal of the test Substance.
- Number of animals:
- 3
- Details on study design:
- Before the experiment was started, the animals had an acclimatization period of at least 5 days. The animals were clearly marked with dye and weighed. Food and drinking water was left for the animals ad libitum. 24 hours before dosing a part of the fur on both sides of the dorso-Iumbal region of each animal was removed by shearing with an electrical shaving machine exposing an area of skin approximately 10 x 15 cm. Care was taken to avoid abrading the skin and only animals with healthy intact skin were used in the experiment. Body weight was recorded immediately before test substance application and on the day of the final observation. As neither corrosive nor strong irritating effects to the skin have been expected the test substance was applied to all three animals for four hours at the same time. 0.5 ml of the test substance was applied to the left flank covered with a gauze pad (3 x 2 cm) which was held in place by strips of Blenderm (3M company, St. Paul, USA). The right flank
served as control region. Semi-occlusive dressings were bandaged with Acrylastic (Beiersdorf AG, Hamburg, Germany) and fixed with Leukoplast (Beiersdorf AG, Hamburg, Germany). Thus access by the animal to the patch and resultant ingestion of the test substance was prevented.
The test substance was removed by washing with tap water after 4 hours exposure time and the application areas were examined.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Any other information on results incl. tables
Skin Reactions: Only very slight erythema but no oedema was observed in one animal 1 h after removal of the test substance Formamidopropyldimethylbetain 50%ig. The numerical scores to the erythema and oedema formations are presented in the following table:
|
Rabbit 504male |
Rabbit 505 RV female |
Rabbit 507 female |
||||||||||||
|
1h |
24h |
48h |
72h |
7d |
1h |
24h |
48h |
72h |
7d |
1h |
24h |
48h |
72h |
7d |
Erythema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Mean (24h-72h) |
|
0 (E) 0 (Oe) |
|
|
0 (E) 0 (Oe) |
|
|
0 (E) 0 (Oe) |
|
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:
- Formamidopropyldimethylbetain 50%ig is not irritating to the skin of rabbits. The mean grades of skin 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, a yellowish clear liquid, was tested regarding its skin irritation potential. The potential to cause inflammatory or corrosive changes upon first contact with skin was
assessed by semi-occluded application of the test substance for four hours to the shorn skin of two female and one male rabbit, strain New Zealand White according to the DECO Guideline for the Testing of Chemicals, 404 "Acute Dermal Irritation/Corrosion". As neither corrosive nor strong irritating effects to the skin have been expected Formamidopropyldimethylbetain 50%ig was applied to all three animals for four hours at the same time. Dermal reactions at the treated skin sites were assessed 1 hour after removal of the test substance and approximately 24, 48, and 72 hours as well as 7 days later.
Systemic toxic symptoms after application were not observed at any time during the study. Body weight development of the animals was positive and within normal ranges. Only very slight erythema but no oedema was observed in one animal 1 h after removal of the
test substance. Especially between 24 and 72 hours no erythema and oedema were observed. The mean scores for erythema and oedema formation for the time period 24 h - 72 h were 0. The Primary Skin Irritation Index was calculated to be 0. Under the conditions of this study the test substance Formamidopropyldimethylbetain 50%ig is non irritating and does not have to be classified for skin irritation.
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.
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