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EC number: 225-896-2 | CAS number: 5137-55-3
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from authoritative database
Data source
Referenceopen allclose all
- Reference Type:
- other: authoritative database
- Title:
- Acute dermal toxicity study of in rabbits
- Author:
- U.S. National Library of Medicine
- Year:
- 2 018
- Bibliographic source:
- Chemidplus Database,U.S. National Library of Medicine,2018
- Reference Type:
- other: authoritative database
- Title:
- Acute dermal toxicity study in rabbits
- Author:
- IFA GESTIS
- Year:
- 2 017
- Bibliographic source:
- Gestis Substance Database ,2017
- Reference Type:
- secondary source
- Title:
- Acute dermal ral toxicity study of test chemical was performed in rats.
- Author:
- NTRL
- Year:
- 1 992
- Bibliographic source:
- NTRL,1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Acute dermal toxicity study of test chemical was performed in rabbits.
- GLP compliance:
- not specified
- Test type:
- other: no data available
- Limit test:
- no
Test material
- Reference substance name:
- Cetrimonium chloride
- EC Number:
- 203-928-6
- EC Name:
- Cetrimonium chloride
- Cas Number:
- 112-02-7
- Molecular formula:
- C19-H42-N.Cl
- IUPAC Name:
- N,N,N-trimethylhexadecan-1-aminium chloride
- Details on test material:
- - Name of test material (IUPAC name): 1-Hexadecanaminium, N,N,N-trimethyl-, chloride
- Common name: Trimethylhexadecylammonium chloride
- Molecular formula: C19H42ClN
- Molecular weight: 320.0008 g/mol
- Smiles notation: C(CCCCCCCCCCCCC)CC[N+](C)(C)C.[Cl-]
- InChl: 1S/C19H42N.ClH/c1-5-6-7-8-9-10-11-12-13-14-15-16-17-18-19-20(2,3)4;/h5-19H2,1-4H3;1H/q+1;/p-1
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Details on test animal
TEST ANIMALS
- Source: Pel neez Farms, Rogen,Arkansas,
- Weight at study initiation: 2.25 and 2.90 kilograms
- Housing: The animals were housed in a lamina air flow room in individual metal cages which were elevated above the droppings.
- Diet (e.g. ad libitum): Purino Rabbit Chow was provided ad libitum
- Water (e.g. ad libitum):water was provided ad libitum
- Acclimation period:14 days
IN-LIFE DATES: From: November 18, 1977 To: December 1, 1977
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The test site was clipped with on Oster small animal clipper to the abraded skin of rabbits.
- % coverage: approximately 25% of the total body surface
- Type of wrap if used: The entire site was covered with a layer of 8-ply gauze, occluded with rubber dental dam and fastened with Johnson and Johnson Zanas porous tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): a wet disposable paper towel was used to remove residual test item.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4300 mg/kg bw - Duration of exposure:
- 24 hours
- Doses:
- 4300 mg/kg bw
- No. of animals per sex per dose:
- Total:6 animals
4300 mg/kg bw: 3 male and 3 female - Control animals:
- not specified
- Details on study design:
- Details on study design
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology - Statistics:
- No data available
Results and discussion
- Preliminary study:
- No data available
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 300 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 50% mortality was observed at dose 4300 mg/kg bw
- Mortality:
- Rabbit No. 114-1-90M was found dead on Day 13, Rabbit No. 1143-975M was found dead on Day 8, and Rabbit No. 1143-979F was found dead on Day 5.
- Clinical signs:
- other: At the end of the 24-hour exposure period all animals exhibited normal behavior and appearance. On the 3rd day ,all rabbits exhibited depressed reflexes, body cold to touch, discharge from the eyes and nose, reddening of the eyes, eating and defecating ve
- Gross pathology:
- Necropsy findings in the animals which died included brown, liquid, fecal material around the anal area, bock legs and in colon, lungs adhered to chest wall, lungs white filled with white granular pockets and 9011 bladder enlarged in Rabbit No. 1143-90M; brownish or clear fluid around nose, mouth, chin and front limbs and no other visible lesions in Rabbit Nos. 1143-975M, and 1143-979F.At termination no visible lesion were noted when necropsies were performed on the surviving rabbits.
- Other findings:
- No data available
Any other information on results incl. tables
Table 1: Dosage Chart and Animal Weights for 1-Hexadecanaminium, N,N,N-trimethyl-, chloride ( 112-02-7).
Rabbit number |
Total Volume Given (ml) |
Initial Weight (kg) |
Terminal Weight (kg) |
1143-89M* |
11.2 |
2.60 |
2.10 |
1143-90M |
12.5 |
2.90 |
1.70** |
1143-975M |
9.7 |
2.25 |
1.35*** |
1143-976* |
9.9 |
2.30 |
2.20 |
1143-979F* |
11.4 |
2.65 |
1.70**** |
1143-112F |
11.4 |
2.65 |
2.30 |
*abraded skin Dosage level 4300 mg/kg of animal body weight
** Died on Day 13
*** Died on Day 8
**** Died on Day 5
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The LD50 value was considered to be 4300 mg/kg bw,when group of 3 male and female New white Zealand rabbits were occlusively treated with test chemical by dermal application following 14 days of observation period.
- Executive summary:
In acute dermal toxicity study,group of 3 male and female New white Zealand rabbits were treated with test chemical in the concentration of 4300 mg/kg bw by dermal application.The test site (approximately 25% of the total body surface) was clipped with on Oster small animal clipper 24 hours prior to application of the test material. The skin of one male and two females was abraded with the clipper head so as to penetrate the horny layer of the epidermis without causing bleeding. The skin of the remaining three rabbits was left intact.The entire site wascovered with a layer of 8-ply gauze, occluded with rubber dental dam and fastened with Johnson and Johnson Zanas porous tape.Each rabbit was restrained in a Newmann harness end returned to their cage for a 24-hour exposure period. At the end of the exposure period, the harness was removed from each rabbit, the occlusive wrap was removed, and any unabsorbed test material was wiped off with a wet disposable paper towel.Each rabbit was examined thoroughly for signs of systemic toxicity, changes in behavior, mortality and dermal irritation for 14 consecutive days foIIowing the day of dosage.After the 14-day observation period, the surviving animals were weighed, killed by an overdose of Beuthanasia D and necropsied to observe any internal gross effects. A gross necropsy was performed on each animal that died.Three of the six rabbits died during the study.At the end of the 24-hour exposure period all animals exhibited normal behavior and appearance.On the 3rd day ,all rabbits exhibited depressed reflexes, body cold to touch, discharge from the eyes and nose, reddening of the eyes, eating and defecating very little or none at all,and clear fluid around the nose, mouth, chin and front limbs.Rabbit Nos. 1143-975M and 1143-979F held their heads in a downward and tilting position and the nictitating membranes and eyelids appeared reddened. These signs persisted throughout the major portion of the study or until death occurred. Signs of skin irritation noted at the end of the 24-hour exposure period included slight to severe erythema, moderate or severe edema and whitening of the skin of the exposure area.The erythema remained relatively unchanged throughout the study while the edema subsided slightly. Also, moderate or severe atonia was noted on Day 3 through termination or until death Occurred, moderate or marked coriaceous skin from Day 2 through termination or until death in all rabbits; and fissuring in three rabbits and desquamation in one animal. All rabbits showed a substantial weight loss during the study. Necropsy findings in the animals which died included brown, liquid, fecal material around the anal area, bock legs and in colon, lungs adhered to chest wall, lungs white filled with white granular pockets and 9011 bladder enlarged in Rabbit No. 1143-90M; brownish or clear fluid around nose, mouth, chin and front limbs and no other visible lesions in Rabbit Nos. 1143-975M, and 1143-979F.At termination no visible lesion were noted when necropsies were performed on the surviving rabbits.Therefore, LD50 value was considered to be 4300 mg/kg bw,when rabbits were treated with test chemical by dermal applicationfollowing 14 days of observation period.
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