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EC number: 226-073-0 | CAS number: 5261-99-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 06 December 2012 to 04 February 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline and EU method. GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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 (incl. QA statement)
Test material
- Reference substance name:
- [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
- EC Number:
- 226-073-0
- EC Name:
- [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride
- Cas Number:
- 5261-99-4
- Molecular formula:
- C7H17N2O2.Cl
- IUPAC Name:
- 4-amino-2-hydroxy-N,N,N-trimethyl-4-oxobutan-1-aminium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
- Analytical purity: 99,4%
- Lot/batch No.: WI 2274
- Storage condition of test material: at room temperature not exceeding 40°C.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Institute of Occupational Medicine, Łódź
- Age at study initiation: The experiment was conducted on one 5-month-old female and two females which were 5.5 months old.
- Weight at study initiation: 3.2-4.4 kg
- Housing: The animals were kept individually in metal cages with the following dimensions: 60 x 35 x 40 cm (length x width x height).
- Diet (e.g. ad libitum): LSK standard granulated laboratory fodder, ad libitum
- Water (e.g. ad libitum): drinking tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 35 – 68%
- Air changes (per hr): about 16 times/hour
- Photoperiod (hrs dark / hrs light): 12 hours light – 12 hours dark
IN-LIFE DATES: From: 7 December 2012 To: 15 December 2012
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- other: drenched with a few drops of water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours after the end of the treatment.
- Number of animals:
- Three females
- Details on study design:
- TEST SITE
- Area of exposure: The area of skin treated with the test item was about 6 cm2.
- Type of wrap if used: The test item was applied to a multilayer gauze patch (2.5 x 2.5 cm) and drenched with a few drops of water. The gauze patch was laid on the prepared skin. The gauze patch was covered with PVC foil and protected using a non-irritating sticking plaster. The rabbit’s trunk was covered with lignin, and an elastic bandage was used to make a circular protecting band.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The band and the gauze patch were taken off and the residual test item was removed using water.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beefy redness) to eschar formation preventing grading of erythema 4
Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 24-72 h
- Score:
- 0
- Irritant / corrosive response data:
- During the reading which took place 1 hour after the end of the exposure, very slight erythema (barely perceptible) was stated on the skin in the site of the test item application in rabbit no. 1. During the readings which took place 24, 48 and 72 hours after the end of the exposure, no pathological changes were observed on the treated skin of the three rabbits.
Any other information on results incl. tables
Table 1: Dermal irritation scores
Erythema |
Oedema |
|||||
Animal No |
1 |
2 |
3 |
1 |
2 |
3 |
after 24 h |
0 |
0 |
0 |
0 |
0 |
0 |
after 48 h |
0 |
0 |
0 |
0 |
0 |
0 |
after 72 h |
0 |
0 |
0 |
0 |
0 |
0 |
Mean score 24 – 72 h |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the available results, the test substance is not classified as skin irritating.
- Executive summary:
The acute skin irritation/corrosion study, according to the OECD Guideline No. 404 / EU Method B.4., was performed in order to obtain information on health hazards likely to arise from skin contact with the test item. The study commenced with a sighting study on one animal. The test item (grounded to a powder) in the amount of 0.5 g was applied only once to the shaved skin of one animal and covered with a protecting band. The exposure lasted 4 hours. After the evaluation of the treated skin, the test item was applied to the skin of the next two rabbits for 4 hours. General clinical observations of all animals for morbidity and mortality were performed daily during the entire experiment. Detailed clinical observations of the treated skin were performed 1, 24, 48 and 72 hours after the end of the exposure. The animals’ body weight was determined on the administration day (day 0) and on the last day of the experiment. During the reading which took place 1 hour after the end of the exposure, very slight erythema (barely perceptible) was stated on the skin in the site of the test item application in rabbit no. 1. During the readings which took place 24, 48 and 72 hours after the end of the exposure, no pathological changes were observed on the treated skin of the three rabbits.
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