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EC number: 939-688-0 | CAS number: -
- 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:
- 1991-05-13 to 1992-04-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 68122-86-1 (partially unsaturated IQAC, DMS quaternised)
- IUPAC Name:
- 68122-86-1 (partially unsaturated IQAC, DMS quaternised)
- Reference substance name:
- partially unsaturated IQAC, DMS quaternised
- IUPAC Name:
- partially unsaturated IQAC, DMS quaternised
- Reference substance name:
- Imidazolium compounds, 2-(C15-17(odd numbered), C17-unsatd. alkyl)-1-[2-(C16-18(even numbered), C18-unsatd. amido)ethyl]-4,5-dihydro-N-methyl, Me sulfates)
- IUPAC Name:
- Imidazolium compounds, 2-(C15-17(odd numbered), C17-unsatd. alkyl)-1-[2-(C16-18(even numbered), C18-unsatd. amido)ethyl]-4,5-dihydro-N-methyl, Me sulfates)
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Test animals
- Source: Charles River Breeding Laboratories, Inc. (Partage, MT)
- Age: Males approx. 63 days; Females: approx. 56 days
- Weight: Males 265 – 320 g upon arrival; Females 172 – 200 g upon arrival
- Fasting period before study: no data given
- Housing: Before mating males were housed singly, females were housed two to a cage.
- During mating 1 male and 1 female were housed individually.
- After mating copulation plug positive females and therefore considered successfully mated
- were housed singly for the duration of the study in stainless steel wire mesh cages.
- Diet: Access ad libitum; Ground Certified Rodent Chow ® (#5002, Ralston Purina Co., St. Louis, MO).
- Water: ad libitum, municipal tap water
- Acclimation period: approx. 2 wks
Environmental Conditions
- Temperature (°C): 19 – 25
- Humidity (%): relative 40 – 70
- Photoperiod: 12 hrs dark/12 hrs light; light period 5 – 17 hrs
In-Life dates: From May 27-30, 1991 to June 14 (gd 15); May 28 – 30, 1991 was gd0.
- Treatment began on gd6 (June 3-5, 1991). Dams were sacrificed on gd21 (June 18 – 20, 1991)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- Preparation of dosing solutions:
Control: Milli-Q ® water, volume according to highest test substance volume selected (1.42 ml / kg bw/day)
Dose levels: The dose levels referring to the active ingredient were 100, 300, and 1000 mg/kg bw/day administered undiluted once a day, based on the dam's body weight on gestational day 6, the percent active ingredient (76,6%) and the specific gravity of the test
substance (0.92 g/cm3). Dosage volumes were not changed to account for increases in gestational body weight after gd6. Accordingly the applied test substance volumes were 0.142, 0.426, and 1.42 mg/kg bw/day - Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- Proof of pregnancy: Females were checked once daily for vaginal copulation plugs in the morning and the paperboard beneath the cages was checked twice daily for dropped copulation plugs. The observation of a vaginal or dropped copulation plug was considered evidence of successful mating. Each male was paired only once in this study.
- Duration of treatment / exposure:
- 10 days, from gd6 through gd15
- Frequency of treatment:
- once daily
- Duration of test:
- 22 days (till gd21)
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 300 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 25; Evaluated pregnant rats: group 1-4: 21/23/22/25 (females with viable fetuses)
Animals evaluated for maternal toxicity: group 1-4: 22/23/24/25 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose selection rationale: Based on a former dose range finding study
Rationale for animal assignment (if not random): The rat is a commonly used rodent species for embryotoxic studies.
Group size per dose level: 22/23/23/25 pregnant animals per dose group
Examinations
- Maternal examinations:
- Cage side observations: yes
Time schedule: daily
Detailed clinical observations: Yes
Time schedule: daily
Clinical signs: Yes
daily observations for behavior, external appearance and general condition
Viability: Yes
daily checks twice daily for morbidity and mortality
Body weight: yes
Time schedule for examinations: Maternal body weights were taken on gd0, gd6 (prior to the onset of dosing), gd9, 12, 15, 18, and 21
Food consumption: yes
Food consumption was measured at three-day intervals throughout the study (gd0 through 21).
Water consumption: no
Post-mortem examinations: Yes
Organs examined: Macroscopic examination of uteri, ovaries, cervix, vagina, peritoneal and thoracic cavities.
Maternal liver and Gravid Uteri weights, Number of Corpora lutea, Number and status of Implantation sites. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
Gravid Uterus weight: yes
Number of corpora lutea: yes
Number of implantations: yes
Number of early resorptions: yes
Number of late resorptions: yes - Fetal examinations:
- Fetal examinations
External examinations: yes: all litter
Soft tissue examinations: yes; approx. 50%
Skeletal examinations: yes, 50%
Head examinations: yes
other: Number of fetuses (live and dead), sex and viability of fetuses, variations and malformations, including cleft palate - Statistics:
- Levene's test for equality of variances, analysis of variance (ANOVA) and t-tests. The t-tests
were used when the F value from the ANOVA was significant. When Levene's test indicated
equal variances, and the ANOVA was significant, a pooled t-test was used for pair wise
comparisons. When Levene's test indicated heterogeneous variances, all groups were
compared by an ANOVA for unequal variances followed, when necessary, by a separate
variance t-test for pair wise comparisons.
Nonparametric data were statistically evaluated using the Kruskal-Wallis test, followed by the
Mann-Whiney U test when appropriate. Incidence data were compared using the Fisher's
Exact Test. With the exception of analyses for fetal malformation and variation data, all
statistical evaluations were performed using BMDP Statistical Software (Dixon, 1990). For all
statistical tests, the probability value of <0,05 (two-tailed) was used as the critical level of
significance.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 300 mg/kg bw/day dose group:
2 dams exhibited audible respiration during or subsequent to the treatment period.
One dam exhibited swelling in the face, urogenital area wetness, gasping and perinasal and perioral encrustation. This animal was sacrificed due to her moribund condition on gd10. None of these signs were considered to be test substance related due to their absence in the dose range finding study up to doses of 1875 mg/kg bw/day and the lack of any dose relation in the current study.
1000 mg/kg bw/day dose group:
3 dams exhibited audible respiration during or subsequent to the treatment period.
No treatment-related differences in gestational parameters including total number of implantations, number of viable and nonviable implants in any dose group. - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 300 mg/kg bw/day dose group:
One female became moribund and was sacrificed on gd10. - Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on gestational body weights and body weight gain, corrected body weight, corrected body weight gain, absolute and relative liver weight, and gravid uterine weight .
Fetal body weights per litter were not affected by treatment.
Increased food consumption in the 100 mg/kg bw/day dose group was not considered to be related to treatment due to the lack of a dose-relationship. - Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- One female in the 300 mg/kg bw/day dose group which was sacrificed due to her moribund condition, had gas-filled intestines, mucoid fluid or material in the nose turbinates, abnormal material in the trachea and discolored and consolidated lungs. One further animal in this dose group had no implants in one uterine horn.
Two females in the 1000 mg/kg bw/day dose group contained blood in the uterus (detected with Hemastix reagent strips) One further female had discolored lungs (dark red) in all lobes.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Details on maternal toxic effects:
- REPRODUCTION DATA OF DAMS (0, 100, 300, 1000 mg/kg bw):
- Corpora lutea:338 (16.1 per dam), 380 (16.5 per dam), 364 (15.7 per dam), 387 (15.5 per dam)
- Implantation sites (Total implants): 340 (15.5 per dam), 379 (16.5 per dam)*, 363 (15.7 per dam)**, 382 (15.3 per dam)
- Resorptions: 10 (0.5 per dam), 7 (0.4 per dam), 12 (0.5 per dam), 53 (2.7 per dam)**
- Early resorptions:13 (0.6 per dam), 21 (0.9 per dam), 17 (0.7 per dam), 14 (0.6 per dam)
- Late resorptions:0 (0 per dam), 1 (0 per dam), 2 (0.1 per dam), 0 (0 per dam)
- Live (Viable) fetuses:327 (14.9 per dam), 356 (15.5 per dam), 343 (14.3 per dam), 367 (14.7 per dam)
* Significantly different from control, p= 0.05 using two-tailed Fisher's exact test
** Significantly different from control, p= 0.01 using two-tailed Fisher's exact test
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- No treatment related effects on fetal body weights (all fetuses, male or female)
observed in any group. The statistically significant differences in mean male and female body weights in litters at 100 mg/kg bw/day were not considered to be treatment-related due to the lack of a dose-response relationship. - Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- Live (Viable) fetuses:327 (14.9 per dam), 356 (15.5 per dam), 343 (14.3 per dam), 367 (14.7 per dam)
- External malformations:
- no effects observed
- Description (incidence and severity):
- Malformations: none significantly different from Control
External variations: none significantly different from control - Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- Malformations: none significantly different from Control
Skeletal variations:
- Anterior arch of atlas poorly ossified; Statistical significance of affected litters in 1000 mg/kg bw/day dose group; % affected litters (71.4, 87.0, 86.4 96.0*)
- Majority of forelimbs unossified; Statistical significance of affected litters in 300 mg/kg bw/day dose group; % affected litters (38.1, 26.1, 4.5**, 24.0)
* Significantly different from control, p= 0.05 using two-tailed Fisher's exact test
** Significantly different from control, p= 0.01 using two-tailed Fisher's exact test - Visceral malformations:
- no effects observed
- Description (incidence and severity):
- Malformations: none significantly different from Control
Soft Tissue variations:
- Excessive bleeding at umbilicus; Statistical significance of affected litters in 100 mg/kg bw/day dose group; % affected litters (23.8, 0*, 27.3, 40.0)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Any other information on results incl. tables
Summary of distribution and fate
group: mg/kg bw/d |
| 0 | 100 | 300 | 1000 |
Females on study |
| 25 | 25 | 25 | 25 |
Mortality | Total % | 0 0.0 | 0 0.0 | 1 * 4.0 | 0 0.0 |
Females that âborted | Total % | 0 0.0 | 0 0.0 | 0 0.0 | 0 0.0 |
Females that delivered | Total % | 0 0.0 | 0 0.0 | 0 0.0 | 0 0.0 |
Femaled removed from study | Total % | 0 0.0 | 0 0.0 | 0 0.0 | 0 0.0 |
Females examined at lapratomy | Total % | 25 100.0 | 25 100.0 | 24 96.0 | 25 100.0 |
Nonpregnant | Total % | 3 12.0 | 2 8.0 | 1 4.2 | 0 0.0 |
Pregnant | Total % | 22 88.0 | 23 92.0 | 23 95.0 | 25 100.0 |
Females with non-viable implants only | Total % | 1 4.5 | 0 0.0 | 1 4.3 | 0 0.0 |
Females with viable fetuses | Total % | 21 95.5 | 23 100.0 | 22 95.7 | 25 100.0 |
* Female sacrificed moribund on GD10
Summary of gestational parameters
group: mg/kg bw/d |
| 0 | 100 | 300 | 1000 |
Corpora lutea | Mean SD N | 16.1 2.02 21 | 16.5 3.57 23 | 15.7 3.53 23 | 15.5 2.50 25 |
Total implants | Mean SD N | 15.5 3.81 22 | 16.5 3.80 23 | 15.7 3.56 23 | 15.3 2.69 25 |
%implantation loss a | Mean SD N | 0.3 1.42 22 | 1.9 4.65 23 | 3.1 10.52 23 | 2.3 4.56 25 |
Viable implants | Mean SD N | 14.9 4.0 22 | 15.5 3.50 23 | 14.8 3.68 23 | 14.7 2.58 25 |
Non-viable implants | Mean SD N | 0.6 0.73 22 | 1.0 1.17 23 | 0.9 0.92 23 | 0.6 0.71 25 |
Early resorptions | Mean SD N | 0.6 0.73 22 | 0.9 1.04 23 | 0.7 0.92 23 | .0.6 0.72 25 |
Late resorptions | Mean SD N | 0.0 0.0 22 | 0.0 0.21 23 | 0.1 0.42 23 | 0.0 0.0 25 |
Dead fetuses | Mean SD N | 0.0 0.0 22 | 0.0 0.21 23 | 0.0 0.42 23 | 0.0 0.0 25 |
%live fetuses | Mean SD N | 92.0 21.10 22 | 94.5 6.29 23 | 90.6 20.54 23 | 96.2 4.63 25 |
Sex ratio (%male fetuses) | Mean SD N | 48.7 11.94 22 | 47.4 17.52 23 | 48.2 16.25 22 | 45.4 14.13 25 |
Fetal body weights per litter [g] |
|
|
|
|
|
All fetuses | Mean SD N | 5.564 0.3494 21 | 5.366 0.2623 23 | 5.516 0.3768 22 | 5.597 0.2476 25 |
Male fetuses | Mean SD N | 5.697 0.3746 21 | 5.499 * 0.2400 23 | 5.685 0.3500 22 | 5.750 0.2448 25 |
Female fetuses | Mean SD N | 5.439 0.3360 21 | 5.230 * 0.2224 22 b | 5.376 0.3980 22 | 5.479 0.2703 25 |
* significantly different from control group (p</0 0.05)
a percent preimplantation loss = [(corpora lutea - total implants)/corpora, lutea] X 100,
b The N is reduced because one litter consisted of male fetuses only.
Applicant's summary and conclusion
- Conclusions:
- In conclusion the test item partially unsaturated IQAC, DMS quaternised possessed no teratogenic properties, not even at the highest dose tested . Embryotoxicity was not observed.
Therefore the NOEL was 1000 mg active ingredient/kg bw/day. The NOEL for maternal toxicity was 1000 mg active ingredient/kg bw/day. - Executive summary:
In a prenatal developmental toxicity study according to EPA OPP 83-3 timed-pregnant CD® (Sprague-Dawley) rats were administered the test item partially unsaturated IQAC, DMS quaternised (75%) by gavage on gestation days (gd) 6 through 15. Twenty-five copulation plug-positive females per group were dosed with undiluted test item at dose levels corresponding to 100, 300, and 1000 mg/kg/day of active ingredient. These dose levels were selected on the basis of results from a dose range-finding study in which no maternal toxicity or evidence of teratogenicity was observed at dose levels as high as 1875 mg/kg/day. An additional 25 females, assigned to the control group, received Milli-Q® water at a dose volume equivalent to that used in the high dose group. Clinical observations were made daily (twice daily during dosing), and maternal body weights were measured on gd 0, 6, 9, 12, 15, 18 and 21. Maternal food consumption was measured at 3-day intervals throughout gestation; gd 0-21. At scheduled sacrifice on gd 21, the dams were evaluated for liver and gravid uterine weights, number of corpora lutea and’ number and status of implantation sites (including early and late resorptions, dead fetuses and live fetuses).
All live and dead fetuses were dissected from the uterus, weighed and examined externally for malformations and variations and gender determinations.
Approximately one-half of the live fetuses in each litter were examined for visceral and craniofacial malformations and variations. The remaining one half of the fetuses were stained with alizarin red S and were examined for skeletal malformations and variations.
The pregnancy rate was equivalent across groups and ranged from 88-100%. No females aborted or delivered early. At scheduled sacrifice, 3 females in the control group; 2 females in the 100 mg/kg/day group and 1 female in the 300 mg/kg/day group were found to be nonpregnant. One female from the control group and 1 female from the 300 mg/kg/day group contained no viable fetuses at scheduled sacrifice. 21 to 25 live litters were available for evaluation from each group.
One female in the 300 mg/kg/day treatment group became moribund and was sacrificed on gd 10. Two to 3 dams in the 300 and 1000 mg/kg/day treatment groups exhibited audible respiration during or subsequent to the treatment period. None of these observations were considered to be test substance related. There were no treatment-related effects on food consumption, gestational body weight and body weight gain, corrected body weight, corrected body weight gain, and gravid uterine weight. No treatment-related differences in gestational parameters including total number of implantations, number of viable and nonviable implants, were observed in any dose group, fetal body weights per litter were not affected by treatment. No treatment-related malformations or variations were observed in this study.
Administration of the test item by gavage to pregnant Charles River CD® rats during organogenesis resulted in no treatment-related maternal toxicity, embryotoxicity, teratogenicity, or developmental delay. In this study, the ‘no observable effect level" (NOEL) for maternal toxicity as well as for developmental toxicity was at least 1000 mg/kg/day.
The developmental toxicity study in the rat is classified acceptable and satisfies the guideline requirement for a developmental toxicity study (OPPTS 870.3700) in rats.
These findings are further backed by the lack of adverse effects in a dose range finding study which was conducted up to a dose level of 1875 mg/kg bw/day.
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