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EC number: 807-655-9 | CAS number: 1629160-48-0
- 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:
- 29 August 1989 to 5 September 1989.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-({2-[(2-hydroxy-2-phenylethyl)({2-[(2-hydroxy-2-phenylethyl)amino]ethyl})amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)[2-(octadecylamino)ethyl]amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)amino]ethyl}[2-(octadecylamino)ethyl]amino)-1-phenylethan-1-ol; 2-{[2-({2-[bis(2-hydroxy-2-phenylethyl)amino]ethyl}(2-hydroxy-2-phenylethyl)amino)ethyl](octadecyl)amino}-1-phenylethan-1-ol
- EC Number:
- 807-655-9
- Cas Number:
- 1629160-48-0
- Molecular formula:
- Not available - UVCB substance
- IUPAC Name:
- 2-({2-[(2-hydroxy-2-phenylethyl)({2-[(2-hydroxy-2-phenylethyl)amino]ethyl})amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)[2-(octadecylamino)ethyl]amino]ethyl}(octadecyl)amino)-1-phenylethan-1-ol; 2-({2-[(2-hydroxy-2-phenylethyl)amino]ethyl}[2-(octadecylamino)ethyl]amino)-1-phenylethan-1-ol; 2-{[2-({2-[bis(2-hydroxy-2-phenylethyl)amino]ethyl}(2-hydroxy-2-phenylethyl)amino)ethyl](octadecyl)amino}-1-phenylethan-1-ol
- Test material form:
- other: solid, moltem mass
- Details on test material:
- - Test article: FAT 92267/A
- Batch N°: EN 3.86
- Content of active ingredients: 81.1%
- Physical properties: Solid, molten mass
- Storage conditions: Room temperature
- Safety precautions: Gloves and face masks
- Test material received: August 18, 1989.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: EN 3.86
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Approx. 12-14 weeks old
- Weight at study initiation: 2240 g to 2990 g
- Housing: The animals were housed individually in metal cages, identified by ear tattoo
- Diet: The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland
- Water: Ad libitum
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A control gauze patch moistened with distilled water was applied to the contralateral flanl.
- Amount / concentration applied:
- 0.5 ml of the test article was applied to the right flank of each animal.
- Duration of treatment / exposure:
- 4 h
- Observation period:
- The skin reactions were evaluated 1, 24, 48 and 72 h afetr removing the gauze patches.
- Number of animals:
- 3 female rabbits
- Details on study design:
- An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 ml of the test article was applied to the right flank of each animal. A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
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 (beet redness) to slight eschar formation ( inj uries in depth): 4
Total possible erythema score 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 nun): 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure): 4
Total possible edema score 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- 3 animal
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- Erythema and edema was seen.
- Other effects:
- All animals showed expected gain in body weight during the study.
Any other information on results incl. tables
|
Individual skin reaction score |
|||||||||||
Time after exposure hours |
Erythema |
Edema |
||||||||||
|
Animal 1 |
Animal 1 |
Animal 3 |
Animal 1 |
Animal 1 |
Animal 3 |
||||||
|
Control flank |
Test flank |
Control flank |
Test flank |
Control flank |
Test flank |
Control flank |
Test flank |
Control flank |
Test flank |
Control flank |
Test flank |
24 |
0 |
2 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
0 |
1 |
48 |
0 |
2 |
0 |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
72 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed, FAT 92267/A is non-irritant to the skin rabbit.
- Executive summary:
The study was performed to assess the irritancy potential of FAT 92267/A to the skin of the New Zealand White rabbit according to the OECD Guideline 404. An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 ml of the test article was applied to the right flank of each animal. A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape. There were no effects on body weight gain. All animals showed erythema and edema during initial days of observation period. Because reactions were observed within 72 h after removing the bandages, the observation period was extended to 7 days to determine the reversibility of the skin reactions. According to the EEC classification of the results obtained 24 to 72 h after removing the bandages FAT 92267/A can be classified as non-irritant in rabbits. The skin reactions observed were reversible until the end of the observation period on day 7. So, under the experimental conditions employed, FAT 92267/A is non-irritant to the skin in rabbits.
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