Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 308-415-1 | CAS number: 97953-16-7
- 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:
- 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)
- Reference substance name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
- EC Number:
- 937-237-2
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- Fatty acids, C16-18 (even numbered) and C18 unsatd., reaction products with diethylene triamine, di-Me sulfate quaternized
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
- 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 analytical verification of doses or concentrations:
- not applicable
- 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)
- 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 substance related due to their absence in the dose range finding study upto 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):
- One female became moribund and was sacrificed on GD10 in the 300 mg/kg bw/day dose group.
- 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 and corrected body weight gain.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- 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.
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on absolute and relative liver weight, and gravid uterine weight .
- 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.
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
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- Implantation sites (Total implants): 340 (15.5 per dam), 379 (16.5 per dam)*, 363 (15.7 per dam)**, 382 (15.3 per dam)
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- Resorptions: 10 (0.5 per dam), 7 (0.4 per dam), 12 (0.5 per dam), 53 (2.7 per dam)
- Early or late resorptions:
- no effects observed
- Description (incidence and severity):
- 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) - Dead fetuses:
- 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)
- Other effects:
- no effects observed
- Description (incidence and severity):
- Fetal body weights per litter were not affected by treatment.
One animal in the 300 mg/kg bw/day dose group had no implants in one uterine horn. - Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No substance related maternal toxicity detected up to the highest dose tested.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- Fetal body weights per litter were not affected by treatment.
Live (Viable) fetuses:327 (14.9 per dam), 356 (15.5 per dam), 343 (14.3 per dam), 367 (14.7 per dam).
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 bodyweights in litters at 100 mg/kg bw/day were not considered to be treatment-related due to the lack of a dose-response relationship. - Skeletal malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Findings: 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*).
Findings: 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). - Visceral malformations:
- effects observed, treatment-related
- Description (incidence and severity):
- Findings: 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)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No embryotoxicity or teratogenicity detected up to the highest dose tested
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day
- 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
TOXIC RESPONSE/EFFECTS BY DOSE LEVEL:
Mortality:
300 mg/kg bw/day dose group:
One female became moribund and was sacrificed on gd10.
Clinical signs:
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.
Body weight:
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.
NECROPSY FINDINGS IN DAMS AT TERMINATION:
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.
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)
- Malformations (external, skeletal, soft tissue) (fetal incidence): none significantly different from Control
- Skeletal variations (fetal incidence):
- Findings: 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*)
- - Skeletal variations (fetal incidence):
- Findings: 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)
- - Soft Tissue variations (fetal incidence):
- Findings: 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)
- Other External variations (fetal incidence): none significantly different from control
Weight of
fetuses: 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.
* 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
Applicant's summary and conclusion
- Conclusions:
- In conclusion the substance 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 developmental toxicity study according to OPP 83-3 the partially unsaturated IQAC, DMS quaternised (75%) was administered to 25 female Sprague CD rats/dose by gavage at dose levels of 0, 100, 300, and 1000 mg/kg bw/day referring to 100 % active substance from day 6 through 15 of gestation. The maternal NOEL is 1000 mg active substance/kg bw/day, based on the lack of effects indicating maternal toxicity. Likewise, the embryotoxic NOEL is 1000 mg active substance/kg bw/day, based on the lack of embryotoxic effects up to the highest dose level. The teratogenic NOEL is 1000 mg active substance/kg bw/day. The partially unsaturated IQAC, DMS quaternised showed no teratogenic properties (no incidence of malformations). The observed variations were isolated without dose relation or lower than in the control group and were therefore not regarded as treatment related. 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.