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EC number: 939-607-9 | CAS number: 1474044-65-9
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication that meets basic scientific principles.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- short exposure time i.e., on gestation Days 7-18 only
- Principles of method if other than guideline:
- 20 mated female rabbits per group were exposed for Days 7 - 18 of gestation to 2.0 mL/kg bw/d of the test substance topically (2 h per day) at concentrations of 0, 0.5, 1.0, or 2.0% (i.e., equivalent to 0, 10, 20 and 40 mg/kg bw/d, respectively). The control group was treated with deionised water.
Animals were observed twice daily for signs of toxicity, including skin irritation from Days 7 to 29. Body weights and food consumption were recorded. A gross necropsy was conducted on animals that died. Foetuses less than 28 d old were fixed in buffered neutral formalin and those 28 d or older were cleared and stained. All surviving dams were sacrificed at study termination on gestation Day 29. An examination of the uterus and ovaries was conducted. Following removal of the foetuses the abdominal and thoracic cavities and organs of the dams were examined. At sacrifice foetuses were identified, weighed and examined externally for defects. Gross dissection and examination of viscera, and internal sex determination also were conducted on each foetus. Finally, an examination of the skeleton for anomalies and ossification variations was conducted after clearing and alizarin red staining of the foetuses. - GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Quaternary ammonium compounds, C12-14 (even-numbered)-alkylethyldimethyl, ethyl sulphates
- EC Number:
- 939-607-9
- Cas Number:
- 1474044-65-9
- Molecular formula:
- C18 H41 N1 O4 S1
- IUPAC Name:
- Quaternary ammonium compounds, C12-14 (even-numbered)-alkylethyldimethyl, ethyl sulphates
- Details on test material:
- - Name of test material (as cited in study report): 1-Hexadecanaminium, N,N,N-trimethyl-, chloride
- Physical state: Liquid
- Analytical purity: 25% aqueous solution
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: Shaved dorsal area.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsed with water and dried.
- Time after start of exposure: 2 h.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg
- Concentration (if solution): 0, 0.5, 1.0 and 2.0% - Duration of treatment / exposure:
- Days 7 - 18 of gestation.
- Frequency of treatment:
- Once daily (2 hours).
- Duration of test:
- Days 0 - 29 of gestation.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 10, 20 and 40 mg/kg bw/day
Basis:
other: Dermal application
- No. of animals per sex per dose:
- 20 pregnant females per dose.
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- Dams were observed twice daily for signs of toxicity, including skin irritation from Days 7 through 29. Body weights were taken on gestation Days 0, 3, 6, 9, 12, 15, 18, 21, 24, 27 and 29. Individual food consumption was measured daily. A gross necropsy was conducted on dams that died in an attempt to determine the cause of death. All surviving dams were sacrificed at study termination on gestation Day 29. An examination of the uterus (including the number and location of live and dead foetuses, early and late resorptions, and implantation sites) and ovaries (including the number of corpora lutea) was conducted. Following removal of the foetuses the abdominal and thoracic cavities and organs of the dams were examined. Uteri from females that appeared non-gravid were placed in 10% ammonium sulphide solution for confirmation of pregnancy.
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes
- Soft tissue examinations: Yes
- Skeletal examinations: Yes - Statistics:
- Body weight changes and food consumption and number of early and late resorptions, dead foetuses, total implantations, corpora lutea, skeletal abnormalities, and mean fetal body weight were compared by analysis of variance (Bartlette's). If variance was not significant, then treatment-control comparisons were made using the least significant difference (LSD) criterion. If variance was significant, then comparison was made using the t-test for unequal variances and the Wilcoxon, Mann-Whitney rank sum test. Additionally, a regression and lack of fit were performed on each of these parameters. The number of pregnancies per group, the percentage of skeletal abnormalities and soft tissue malformations were analysed by Fisher's exact test.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects. Remark: No test substance related significant effects.
Details on maternal toxic effects:
Two control, one intermediate and one high dose doe died during the study. The cause of death could not be determined. Two of the does that died aborted prior to death (one control and one intermediate dose group animal). Two additional abortions occurred, one each in the intermediate and high dose groups. None of these deaths or abortions were considered related to test substance toxicity. Skin irritation was observed at all doses with the severity and duration of erythema, oedema, desquamation, atonia and coriaceousness increased in a dose-dependent manner. No treatment-related maternal body weight or food intake effects were noted. A slight increase in congested lungs was observed for the high dose group at necropsy.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The incidence of foetal malformation and genetic and developmental variation in the treated groups was comparable to that of the control group.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, the NOAEL of the test substance for maternal as well as developmental toxicity was found to be 40 mg/kg bw/d in rabbits.
- Executive summary:
A guideline study was carried out to assess the effects of C16 TMAC on embryonic and foetal development in New Zealand White rabbits. Twenty mated female rabbits per group were exposed topically (daily for 2 hours) from Days 7 to 18 of gestation at concentrations of 0, 0.5, 1.0, or 2.0% (equivalent to 0, 10, 20 and 40 mg a.i./kg bw/day, respectively). The control group was treated with deionised water only. Clinical condition and reactions to treatment were recorded at least once daily. Body weights were recorded on Days 0, 3, 6, 9, 12, 15, 18, 21, 24, 27 and 29 of gestation. All surviving females were sacrificed on Day 29 of gestation and the foetuses were removed by caesarean section. At necropsy the females were examined macroscopically. Live foetuses were weighed, sexed and were examined for visceral and skeletal abnormalities. Two control animals, one intermediate and one high dose died during the study. Two of the rabbits that died, aborted prior to death (one control and one intermediate dose). Two additional abortions occurred, one each in the intermediate and high dose groups. Deaths or abortions were not considered to be related to the test substance. No treatment-related maternal body weight or food intake effects were noted. The incidence of foetal malformations and genetic and developmental variations in the treated groups was comparable to that of the control group. No other treatment-related effects were noted. Under the conditions of the study, the NOAEL for maternal as well as developmental toxicity was 40 mg a.i./kg bw/day in rabbits.
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