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EC number: 268-071-2 | CAS number: 68002-58-4 This substance is identified by SDA Substance Name: C14-C18 dialkyl dimethyl ammonium methyl sulfate and SDA Reporting Number: 17-049-00.
- 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:
- weight of evidence
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
- Principles of method if other than guideline:
- - Principle of test:
Six albino rabbits of the New Zealand strain were placed in a collar such that the animals could not rub their eyes. 0.1 g of the substance were instilled in one eye, the other untreated eye served as control. Damage to the cornea, iris and the bulbar and palpebral conjunctivae were scored at 24, 48 and 72 h after eye instillation. Any residue of the test material and accumulated discharge are flushed from the eye each time they are scored.
- Parameters analysed / observed:
Damage to the eye, i.e. opacity of the cornea and the area of opacity, reaction of the iris and redness, chemosis and discharge of the conjunctivae were scored. - GLP compliance:
- no
- Remarks:
- study conducted prior to implementation of GLP
Test material
- Reference substance name:
- Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates
- Cas Number:
- 68002-58-4
- IUPAC Name:
- Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral, untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- The substance was once instilled and the treated eye was flushed if any residual or accumulated test item was visible at each scoring time point.
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 6 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): If residual or accumulated test substance was visible the treated eye was washed at each scoring time point
- Time after start of exposure: The first scoring time point was 24 h after eye instillation
SCORING SYSTEM: Draize scale
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #3, #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritation parameter:
- iris score
- Basis:
- animal: #1 - #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2, #5
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3, #6
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: #5, #6
- Time point:
- 24/48/72 h
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- duration of observation was 72 h
- Irritant / corrosive response data:
- During the observation period, corneal opacity scores were 0 in 3/6 animals, 1 in 2/6 animals and 2 in 1/6 animals. Iris scores were 0 throughout the observation period. Conjunctival redness was scored 3 after 24 h in all animals, 2-3 after 48 h, and 0-2 after 72 h. Chemosis scores were 2-3 after 24 h, 2 after 48 h, and 0-2 after 72 h. As the animals were observed only for 72 h, and effects were still present at study termination, reversibility cannot finally be evaluated. Nevertheless, a tendency towards reversion was noted.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test
Score at time point / Reversibility |
Cornea |
Iris |
Conjunctivae |
Chemosis |
Max. score: 4 |
Max. score: 2 |
Max. score: 3 |
Max. score: 4 |
|
24 h |
0/2/0/0/1/1 |
0/0/0/0/0/0 |
3/3/3/3/3/3 |
2/3/2/2/3/3 |
48 h |
0/2/0/0/1/1 |
0/0/0/0/0/0 |
2/3/2/2/3/2 |
2/2/2/2/2/2 |
72 h |
0/2/0/0/0/1 |
0/0/0/0/0/0 |
0/2/2/1/2/2 |
0/2/0/1/2/2 |
Average 24h, 48h, 72h |
0/2/0/0/0.67/1 |
0/0/0/0/0/0 |
1.67/2.67/2.33/2/2.67/2.33 |
1.33/2.33/1.33/1.67/2.67/2.67 |
Reversibility*) |
n.c. |
c. |
n.c. |
n.c. |
Average time (unit) for reversion |
72 h |
|
72 h |
72 h |
*) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on scores for conjunctival redness and chemosis, C14-18 alkyldimethyl ammonium methosulfate (89% a.i.) has to be classified for eye irritation. However, discrimination between Category 1 and 2 is not possible based on this study.
- Executive summary:
In a primary eye irritation study conducted prior to implementation of GLP and OECD guidelines 0.1 g of C14-18 alkyldimethyl ammonium methosulfate (89% a.i.) was instilled into the conjunctival sac of one eye of 6 adult New Zealand White rabbits. The substance was once instilled and the treated eye was flushed if any residual or accumulated test item was visible at each scoring time point (24, 48, 72 h). Animals were observed for 3 days. Irritation was scored by the method of Draize.
During the observation period, corneal opacity scores were 0 in 3/6 animals, 1 in 2/6 animals and 2 in 1/6 animals. Iris scores were 0 throughout the observation period. Conjunctival redness was scored 3 after 24 h in all animals, 2-3 after 48 h, and 0-2 after 72 h. Chemosis scores were 2-3 after 24 h, 2 after 48 h, and 0-2 after 72 h. As the animals were observed only for 72 h, and effects were still present at study termination, reversibility cannot finally be evaluated. Nevertheless, a tendency towards reversion was noted.
Based on scores for conjunctival redness and chemosis, C14-18 alkyldimethyl ammonium methosulfate (89% a.i.) has to be classified for eye irritation. However, discrimination between Category 1 and 2 is not possible based on this study.
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