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EC number: 937-237-2 | CAS number: 1370006-50-0
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-03-23 to 2010-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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 (incl. QA statement)
Test material
- Reference substance name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
- Cas Number:
- 1370006-50-0
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 2818.2 9 and 2709.8 9 (female), 2912.6 9 (male). In deviation to the study plan the animals were slightly overweight (weight > 2500 g). However, this deviation is considered not affecting the outcome of the study.
- Housing: in steel cages with a plastic bottom, a non-barrier system with air conditioning was used.
- Diet: ad libitum, food of type "2023 Maintenance diet for rabbits " frorn Altramin, Lage, Germany as pelleted diet (Batch Nos.: 0926 and 1354; expiry dates: 2010-07-07 and 2010-12-02)
- Water: ad libitum, tap water from municipal source (SWK AQUA GmbH, Krefeld, Germany)
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 % -70 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remained untreated and served as a control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml of the test substance
- Concentration (if solution): unchanged - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3 animals: 2-females, 1 male
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
After recording the observations at 24 hours, the eyes of all rabbits were further examined with the aid of fluorescein. One drop of a 0.5 % (w/v) fluorescein solution in saline was poured into both eyes and washed off with saline solution 30 seconds later.
SCORING SYSTEM: the ocular reactions were assessed using the following numerical scoring system:
I.) Cornea opacity
No ulceration or opacity 0
Scattered or diffuse areas of opacity, details of iris clearly visible 1
Easily discernible translucent areas, details of iris slightly obscured 2
Nacreous areas, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible thraugh the opacity 4
I.) Cornea area
No lesion 0
One quarter (or less) but not zero 1
Greater than one quarter, but less than one half 2
Greater than one half, but less than three quarters 3
Greater than three quarters, up to whole area 4
lI.) Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate
circumcorneal hyperaemia or injection, iris still reactive to light 1
No reaction to light, haemorrhage, or grass destruction 2
III.) Conjunctivae redness
Vessels normal 0
Some blood vessels hyperaemic ( injected) above normal 1
More diffuse, crimson colour, individual vessels not easily discernible 2
Diffuse beefy red 3
III.) Conjunctivae chemosis
Normal 0
Some swelling above normal 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
III.) Conjunctivae discharge
No discharge 0
Any amount different from normal ( does not include
small amounts observed in inner canthus of normal animals) 1
Discharge with moistening of the lids and hairs just adjacent to the lids 2
Discharge with moistening of the lids and hairs and affecting
a considerable area around the eye 3
TOOL USED TO ASSESS SCORE: fluorescein (Fluorescein sodium C.I. 45350, Merck KGaA, Darmstadt, Germany)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1,#2,#3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1,#2,#3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1,#2,#3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- All three animals showed moderate ocular reaction 1 h after application of the test substance (two scores for conjunctivae redness and chemosis). 24 h after application moderate ocular reactions were still observed in all three animals. Cornea opacity or iris irritation was not observed in any of the three animals. Slight irritation of the conjunctivae persists until 72 h after treatment in all animals but 7 days after application all three animals were without any sign of ocular irritation.
- Other effects:
- Symptoms of systemic toxicity caused by the test substance were not observed during the whole study. Body weight gain was positive and within normal range.
Any other information on results incl. tables
Examination of the treated eyes was carried out 1 hour and 24, 48, 72 hours and 7 days after application of the test substance.
|
1 h |
24 h |
48 h |
72 h |
7 d |
Mean (24h-72h) |
|
I. Cornea opacity Cornea area |
A |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
B |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
|
II. Iris |
A |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
0/0/0 |
III. Conjunctivae redness Conjunctivae chemosis Conjunctivae discharge |
A |
2/2/2 |
2/2/2 |
1/1/1 |
1/1/1 |
0/0/0 |
1.33/1.33/1.33 |
B |
2/2/2 |
2/2/1 |
2/2/1 |
1/2/1 |
0/0/0 |
1.67/2/1 |
|
C |
1/1/1 |
1/1/1 |
0/0/0 |
0/0/0 |
0/0/0 |
0.33/0.33/0.33 |
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:
- Moderate ocular reactions were observed within 24 hour following application of 0.1 mL of the test substance to the eyes. Effects on the cornea and the iris did not occur. The severity of the observed effects declined with time and the lesions were completely reversible within 7 days.
- Executive summary:
In a primary eye irritation study according to OECD Guideline 405 (2002), 0.1 mL of partially unsaturated IQAC, DMS quaternised
(75 % in propylene-glycol) was instilled into the conjunctival sac of three New Zealand White rabbits. The eyes were not rinsed after substance application. Animals then were observed for 7 days. Irritation was scored by the method of Draize.At 24 hours post application the eyes of all animals were further examined with fluorescein for cornea damage. All three animals showed moderate ocular reaction 1 h after application of the test substance (two scores for conjunctivae redness and chemosis). 24 h after application moderate ocular reactions were still observed in all three animals. Cornea opacity or iris irritation was not observed in any of the three animals. Slight irritation of the conjunctivae persisted until 72 h after treatment in all animals but 7 days after application all three animals were without any sign of ocular irritation.
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