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EC number: 614-637-2 | CAS number: 68603-75-8
- 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:
- 1987-03-04 to 1987-06-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study without detailed documentations (very few information on the tested substance reported)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-({3-[(2-hydroxypropyl)[(9E)-octadec-9-en-1-yl]amino]propyl}amino)propan-2-ol; 1-({3-[(2-hydroxypropyl)amino]propyl}(octadecyl)amino)propan-2-ol; 1-({3-[hexadecyl(2-hydroxypropyl)amino]propyl}amino)propan-2-ol
- EC Number:
- 614-637-2
- Cas Number:
- 68603-75-8
- Molecular formula:
- R-N(CH2CHOHCH3)xCH2CH2CH2N(CH2CHOHCH3)y with x+y=3 and where R = alkyl
- IUPAC Name:
- 1-({3-[(2-hydroxypropyl)[(9E)-octadec-9-en-1-yl]amino]propyl}amino)propan-2-ol; 1-({3-[(2-hydroxypropyl)amino]propyl}(octadecyl)amino)propan-2-ol; 1-({3-[hexadecyl(2-hydroxypropyl)amino]propyl}amino)propan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): DINORAM SL
- Physical state: Dark brown liquid
- Lot/batch No.: 96 01 267
No other data available
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Abbaye de Bellefontaine, Beggroles en Mauges, France
- Age at study initiation: no data
- Weight at study initiation: Mean weight: 2.6 +/- 0.1 kg
- Housing: The rabbits were individuall y housed in polystyrene cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3° C
- Humidity (%): 50 +/-20%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours per day
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: each animal served as its own control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100 %
VEHICLE
- no vehicle - Duration of treatment / exposure:
- 3 minutes for 3 animals and four hours for 3 other animals.
- Observation period:
- 1hour, 24, 48 and 72 hours after patch removal then daily until day 14.
- Number of animals:
- 6 males
- Details on study design:
- TEST SITE
- Area of exposure: flank, clipped 24 h before exposure and checked for healthy, intact skin before application
- % coverage: 6 cm²
- Type of wrap if used: dry gauze pad held in contact with the skin by means of a semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test substance was wiped off by means of a gauze saturated with sterile pyrogen-free water.
- Time after start of exposure: 3 minutes or 4 hours
SCORING SYSTEM:
Dermal irritation was evaluated for each animal according to OECD guideline 404 (draize scoring system)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- (for 3 minute- exposure)
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Remarks:
- (for 3-minute exposure)
- Basis:
- animal #2
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 13 days
- Irritation parameter:
- erythema score
- Remarks:
- (for 3-minute exposure)
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- other: Dryness of the skin persisted at the end of the observation period.
- Irritation parameter:
- edema score
- Remarks:
- ( for 3-minute exposure)
- Basis:
- animal #1
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Remarks:
- (for 3-minute exposure)
- Basis:
- animal #2
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Irritation parameter:
- edema score
- Remarks:
- (for 3-minute-exposure)
- Basis:
- animal #3
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 2.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Remarks:
- (for 4-hour exposure)
- Basis:
- animal #4
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 3.7
- Max. score:
- 4
- Reversibility:
- other: Dryness of the skin persisted at the end of the observation period.
- Irritation parameter:
- erythema score
- Remarks:
- (for 4-hour exposure)
- Basis:
- animal #5
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: necrosis from day 3 to 6 then crusts and dryness of the skin.
- Irritation parameter:
- erythema score
- Remarks:
- (for 4-hour exposure)
- Basis:
- animal #6
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 4
- Max. score:
- 4
- Remarks on result:
- other: necrosis from day 2 to 6 then crusts and dryness of the skin.
- Irritation parameter:
- edema score
- Remarks:
- (for 4-hour exposure)
- Basis:
- animal #4
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- ( for 4-hour exposure)
- Basis:
- animal #5
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: day 7
- Irritation parameter:
- edema score
- Remarks:
- (for 4-hour exposure)
- Basis:
- animal #6
- Time point:
- other: mean of the 24, 48 and 72-hour readings
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- - Application for 3 minutes :
Slight to severe erythema and oedema were observed in all animals. These reactions regressed slowly. They were totally reversible in 8 and 13 days in 2 rabbits. Dryness of the skin was still present at the end of the observation period in the remaining one (See tables 1 and 2 in results and discussion free-text for details).
_ Application for 4 hours:
Moderate to severe erythema and oedema were observed in all animals. Erythema regressed slowly and was no more visible on Day 14 in 1 animal. Dryness of the skin or crusts were still present at the end of the observation period in the 2 others. Oedema disappeared on Day 7 in all rabbit.
24 and 48 hours after application, necrosis were noted in 2 rabbits and persisted until day 6 . Crusts were then observed until day 11 for one animal and till the end of the observation period for the remaining one (See tables 3 and 4 in results and discussion free-text for details).
Any other information on results incl. tables
Table 1: Erythema scores after a 3- minute exposure
Animal | 1 hour (D1) | 24 hours (D2) | 48 hours (D3) | 72 hours (D4) | D5 | D6 | D7 | D8 | D9 | D10 | D11 | D12 | D13 | D14 |
1 | 0 | 2 | 2 | 1 | 1 | 1/S | 0/S | 0 | - | - | - | - | - | - |
2 | 0 | 3 | 4 | 4 | 4 | 4/S | 3 | 2/S | 1/S | 1/S | 0/S | 0/S | 0 | - |
3 | 0 | 3 | 4 | 4 | 4 | 4/S | 0/S | 0/S | 0/S | 0/S | 0/S | 0/S | 0/S | 0/S |
Grading scale according to OECD 404 guidelines
Table 2: Oedema scores after a 3 -minute exposure
Animal | 1 hour (D1) | 24 hours (D2) | 48 hours (D3) | 72 hours (D4) | D5 | D6 | D7 | D8 | D9 | D10 | D11 | D12 | D13 | D14 |
1 | 0 | 2 | 2 | 1 | 1 | 0 | 0 | 0 | - | - | - | - | - | - |
2 | 0 | 4 | 4 | 4 | 4 | 4 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | - |
3 | 0 | 3 | 2 | 2 | 2 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Grading scale according to OECD 404 guideline
Table 3: Erythema scores after a 4- hour exposure
Animal | 1 hour (D1) | 24 hours (D2) | 48 hours (D3) | 72 hours (D4) | D5 | D6 | D7 | D8 | D9 | D10 | D11 | D12 | D13 | D14 |
4 | 1 | 3 | 4 | 4 | 4 | 4/S | 4/S | C/S | C/S | C/S | 0/S | 0/S | 0/S | 0/S |
5 | 2 | 4 | N | N | N | N | C/S | C/S | C/S | C/S | C/S | 0/S | 0/S | 0 |
6 | 2 | N | N | N | N | N | C/S | C/S | C/S | C/S | C/S | C/S | C | C |
Grading scale according to OECD 404 guideline
Table 4: Oedema scores after a 4 -hour exposure
Animal | 1 hour (D1) | 24 hours (D2) | 48 hours (D3) | 72 hours (D4) | D5 | D6 | D7 | D8 | D9 | D10 | D11 | D12 | D13 | D14 |
4 | 1 | 3 | 3 | 3 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 2 | 4 | 4 | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 2 | 4 | 4 | 4 | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Grading scale according to OECD 404 guideline
C = crusts, N= necrosis, S= dryness of the skin
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
- Conclusions:
- Under the experimental conditions of this study and according to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the test material is classified Skin corrosive category 1 C, H314 and Corrosive R34 respectively.
- Executive summary:
The potential of the test substance to induce skin irritation was assessed in 6 rabbits according to the OECD 404 guideline in compliance with the
principles of Good Laboratory Practice regulations.A single dose of 0.5 ml of the test substance was applied to the skin of 3 rabbits under a semi-occlusive dressing for a 3 -minute exposure period. 3 other rabbits received the test substance under the same protocol but for an exposure period of 4 hours . Skin reactions were observed 1, 24, 48, 72 hours after removal of the dressing and then daily until day 14 in order to observe their reversibility. The mean values of the scores for erythema and oedema were calculated for each animal.
After 3 minutes of exposure, the mean scores over 24, 48 and 72 hours for individual animals were 1.7, 3.7 and 3.7 for erythema and 1.7, 4.0 and 2.3 for oedema. Slight to severe erythema and oedema were observed in all animals. These reactions regressed slowly. They were totally reversible in 8 and 13 days in 2 rabbits. Dryness of the skin was still present at the end of the observation period in the remaining one.
After 4 hours of exposure, the mean scores over 24, 48 and 72 hours for individual animals were 3.7 for erythema in one rabbit, the scores of the 2 others were not calculable due to necrosis. Indeed, 24 and 48 hours after application, necrosis were noted in 2 rabbits and persisted until day 6 . Crusts were then observed until day 11 for one animal and till the end of the observation period for the remaining one. For the third rabbit, erythema regressed slowly and was no more visible on Day 14.
Mean scores over 24, 48 and 72 hours for individual animals were 3.0, 4.0 and 4.0 for oedema . Oedema disappeared on Day 7 in all rabbits.
Under these experimental conditions, the test substance was considered to be corrosive to the rabbit skin after 4 hours of exposure.
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