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Diss Factsheets
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EC number: 629-742-9 | CAS number: 1226892-49-4
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Developmental toxicity / teratogenicity
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited reporting, method similar to OECD 414. US EPA evaluated: Reliable without restriction; guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 992
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
- Details on test material:
- Identity: Varisoft 475 (75%)
CAS RN: 68122-86-1;
Chemical name: Imidazolium compounds, 4,5-dihydro-1-methyl-2-nortallow alkyl-1-(2-tallow amidoethyl) Me sulfate)
Purity: 76.6% in isopropyl alcohol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- Timed-pregnant rats
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- copulation plug-positive females
- Duration of treatment / exposure:
- gestation days (gd) 6 through 15.
- Frequency of treatment:
- Daily
- Duration of test:
- until gd 21
Doses / concentrations
- Remarks:
- Doses / Concentrations:
o, 100, 300 and 1000 mg a.i./kg bw/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- Twentyfive females per group
- Control animals:
- yes
- Details on study design:
- control group received Milli-Q water at a dose volume equivalent to that used in the high dose group.
Examinations
- Maternal examinations:
- 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. At scheduled sacrifice on gd 21, the dams were evaluated for liver and gravid uterine weights.
- Ovaries and uterine content:
- gravid uterine weights, number of corpora lutea and number and status of implantation sites (including early and late resorptions, dead fetuses and live fetuses).
- Fetal examinations:
- 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.
- Statistics:
- The unit of comparison was the pregnant dam or the litter.
ANOVA, t-tests, Kruskal-Wallis Test, Mann-Whitney U Test and Fisher’s Exact Test were used where appropriate.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (nominal)
- Based on:
- act. ingr.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day
- Based on:
- act. ingr.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL (maternal and developmental) >1000 mg/kg-day (highest dose tested)
- Executive summary:
The objective of this study was to evaluate the potential of the test substance to produce developmental toxicity when administered by a gavage to pregnant CD® rats during organogenesis. Maternal toxicity was also evaluated. Timed-pregnant rats were administered the test substance by gavage on gestation days (gd) 6 through 15. Twentyfive copulation plug-positive females per group were dosed with undiluted test substance at dose levels corresponding to 100, 300 and 1000 mg active ingredient/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. 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). 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.
Maternal: The pregnancy rate was equivalent across groups and ranged from 88 - 100%. No females aborted or delivered early. At scheduled sacrifice, three females in the control group, two females in the 100 mg/kg/day group and one female in the 300 mg/kg/day group were found to be nonpregnant. One female from the control group and one female from the 300 mg/kg/day group contained no viable fetuses at scheduled sacrifice. Twenty-one 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 three 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 treatmentrelated differences in gestational parameters including total number of implantations, number of viable implants, and number of nonviable implants, were observed in any dose group.
Fetal: Fetal body weights per litter were not affected by treatment.
No treatment-related malformations or variations were observed in this study.
Maternal toxicity NOEL: > 1000 mg/kg/day
Developmental toxicity NOEL: > 1000 mg/kg/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.
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