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EC number: 269-824-8 | CAS number: 68334-33-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 1983-11-16 to 1983-11-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Although this study is guideline and GLP compliant and would normally be assigned a reliability of 1 (reliable without restrictions), this study is used for read-across and therefore has been assigned a reliability of 2 (reliable with restrictions).
- Justification for type of information:
- The primary component of all substances provide complete coverage of 68334-33-8. 68334-33-8 shares high structural similarity with 61789-80-8, 68783-78-8, 107-64-2, and 112-02-7. As 68334-33-8 is a UVCB its components encapsulate the other substances except for the counter ion (Cl-). In solution, the counter ions will dissociate from the parent structures. Therefore, we are comparing substances of equivalent nature. CAS 107-64-2 represents the C18 boundary of the 61789-80-8. Ignoring the salt component CAS 61789-80-8 is equivalent to CAS 68334-33-8. 68783-78-8 is a worst case of both 68334-33-8 and 61789-80-8 since it is unsaturated and the SP2 carbon-carbon bonds are of higher reactivity and a more likely site of metabolic activation. The primary component of CAS 112-02-7 is a substructure of all the other substances. Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- The primary component of all substances provide complete coverage of 68334-33-8. 68334-33-8 shares high structural similarity with 61789-80-8, 68783-78-8, 107-64-2, and 112-02-7. As 68334-33-8 is a UVCB its components encapsulate the other substances except for the counter ion (Cl-). In solution, the counter ions will dissociate from the parent structures. Therefore, we are comparing substances of equivalent nature. CAS 107-64-2 represents the C18 boundary of the 61789-80-8. Ignoring the salt component CAS 61789-80-8 is equivalent to CAS 68334-33-8. 68783-78-8 is a worst case of both 68334-33-8 and 61789-80-8 since it is unsaturated and the SP2 carbon-carbon bonds are of higher reactivity and a more likely site of metabolic activation. The primary component of CAS 112-02-7 is a substructure of all the other substances. Additional documentation, provided within the IUCLID Assessment Reports section, supports the read-across approach.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Remarks on result:
- other: expressed as Arquat 2HT-75 (a 75% dilution)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- but a statement that the report and the study were audited by the Quality Assurance unit is included.
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides
- EC Number:
- 295-835-2
- EC Name:
- Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides
- Cas Number:
- 92129-33-4
- Molecular formula:
- R2N+(CH3)2, Cl- with R is fatty alkyl with chainlengths C16-C18 (even numbered)
- IUPAC Name:
- N-C16-C18(even numbered)-alkyl-N,N-dimethyl-C16-C18(even numbered)-alkyl-1-aminium chloride
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hacking and Churchill Limited, Huntingdon, UK
- Age at study initiation: four to six weeks of age
- Weight at study initiation: 87 to 108 g
- Fasting period before study: overnight prior and approximately 4 hours after dosing.
- Housing: in groups by sex in metal cages with wire mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days prior to the start of the main study
ENVIRONMENTAL CONDITIONS
- Temperature : 23 to 24 °C
- Humidity: 47 %
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12hr/12hr
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: the test item was prepared as a 50 % w/v suspension in 1% methyl cellulose.
- Amount of vehicle (if gavage): dose volumes were calculated from the body weights of the rats and the selected dose volume did not exceed 10 mlLkg body weight. - Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5 rats/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at frequent intervals on day 1 (day of dosing) then at least twice a day, weighing at 1, 8 and 15 days after exposure
- Necropsy of survivors performed: yes - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 5 000 mg/kg bw
- Remarks on result:
- other: expressed as Arquat 2HT-75 (a 75% dilution)
- Mortality:
- No deaths were observed during the study.
- Clinical signs:
- other: - In all animals, piloerection, pallor of the extremities and hunched posture were observed from day 1 to day 4 (recovery complete by day 4). - In all females and 2 males, abnormal gait was observed from day 1 to day 4 (recovery complete by day 4).
- Gross pathology:
- No abnormalities were detected at autopsy.
Any other information on results incl. tables
Acute oral toxicity, limit test, cumulative mortality |
||||
Day |
Dose (mg/kg bw) |
Sex |
Dose (mg/kg bw) |
Sex |
5000 |
F |
5000 |
M |
|
Cumulative mortality |
Cumulative mortality |
|||
1 |
0/5 |
0/5 |
||
2 |
0/5 |
0/5 |
||
3 |
0/5 |
0/5 |
||
4 |
0/5 |
0/5 |
||
5 |
0/5 |
0/5 |
||
6 |
0/5 |
0/5 |
||
7 |
0/5 |
0/5 |
||
8 |
0/5 |
0/5 |
||
9 |
0/5 |
0/5 |
||
10 |
0/5 |
0/5 |
||
11 |
0/5 |
0/5 |
||
12 |
0/5 |
0/5 |
||
13 |
0/5 |
0/5 |
||
14 |
0/5 |
0/5 |
||
15 |
0/5 |
0/5 |
Acute oral toxicity, limit test, 5000 mg/kg bw |
|||
Sex |
Mean body weight in grams |
||
Day 1 |
Day 8 |
Day 15 |
|
M |
105 |
178 |
255 |
M |
103 |
186 |
272 |
M |
95 |
177 |
255 |
M |
93 |
163 |
239 |
M |
107 |
188 |
250 |
F |
90 |
142 |
174 |
F |
87 |
142 |
189 |
F |
102 |
161 |
203 |
F |
107 |
161 |
200 |
F |
108 |
169 |
206 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on this study, the acute oral LD0 of the 75% dilution of the substance is equal to or greater than 5000 mg/kg bw.
- Executive summary:
The objective of this study was to evaluate the toxicity of a 75% dilution of the test item (DHTDMAC 75% active in isopropanol/water) following a single oral administration in rats according to OECD guideline 401. A statement that the report and the study were audited by the Quality Assurance Unit of the testing laboratory was provided. The test material was prepared in 1% methylcellulose suspension and was administered by gavage under a dosage-volume of 10 mL/kg bw to 2 groups of 5 male and 5 female rats. Based on a preliminary study indicating no deaths in 2 males and 2 female rats at 5000 mg/kg bw, the main experiment was performed at the limit dose level of 5000 mg/kg bw. Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.
At the dose level of 5000 mg/kg, no mortality and no effects on body weight gain were observed.
Piloerection, pallor of the extremities and hunched posture were observed in all animals from day 1. Abnormal gait was also recorded in 2 out of 5 males and 5 out of 5 females. Recovery was complete by day 4. At necropsy, there were no apparent abnormalities. Under these experimental conditions, the oral LD0 of the 75% dilution of the substance is equal to or greater than 5000 mg/kg bw.
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