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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 951-974-7 | 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
Toxicity to reproduction
Administrative data
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: subacute repeated dose toxicity study in rodents
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-02-09 to 2009-03-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral)) 30 May 2008)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 407, adopted 03 October 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- MDEA Esterquat C18 satd.
- IUPAC Name:
- MDEA Esterquat C18 satd.
- Details on test material:
- - Name of test material (as cited in study report): Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride
- Physical state: solid
-Analytical purity: 98.5%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: Females: 187 - 223 g (mean: 201 g); Males: 241 - 290 g (mean: 266 g)
- Housing: Full-barrier in an air conditioned room. The animals were kept individually in IVC cages.
- Diet (e.g. ad libitum): ad libitum (Altromin 1324 maintenance diet)
- Water (e.g. ad libitum): ad libitum (sulphur acidified tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2009-02-09 To: 2009-03-30
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
PREPARATION
The test item formulations were prepared freshly on each administration day, before the administration procedure.
The test item was dissolved while stirring and heated up to approx. 70° C in Aqua ad injectionem (sterile water). As guaranteed by the sponsor this procedure did no affect the chemical stability of the test compound.
VEHICLE
- Concentration in vehicle: 10% w/w
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no. (if required): Lot 7494A191, expiry date: Nov. 2010
- Purity: aqua ad injectionem - Details on mating procedure:
- animals were not mated
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Analysis of the dosing preparations of the test item in the vehicle (nominal concentration) was performed once a week by two-phase titration.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily, 7 days per week
Doses / concentrations
- Remarks:
- Doses / Concentrations: 62.5, 250, 1000 mg/kg bw/d; Basis: actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control:
- No
Examinations
- Oestrous cyclicity (parental animals):
- not examined
- Sperm parameters (parental animals):
- not examined
- Litter observations:
- n.a.
- Postmortem examinations (offspring):
- n.a.
- Reproductive indices:
- n.a.
- Offspring viability indices:
- n.a.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
Effect levels (P0)
- Dose descriptor:
- NOEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- act. ingr.
- Sex:
- male/female
- Basis for effect level:
- other: No significant treatment related effects on reproductive organs (weights and histopathology) were seen at the highest dose administered
Results: P1 (second parental generation)
Effect levels (P1)
- Remarks on result:
- other: No P1 generation was used in this 28 day sub acute study.
Results: F1 generation
Effect levels (F1)
- Remarks on result:
- other: No F1/F2 offspring generations were used in this subacute 28 day study.
Results: F2 generation
Effect levels (F2)
- Remarks on result:
- other: No F1/F2 offspring generations were used in this subacute 28 day study.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
ORGAN WEIGHTS
There were no significant differences in relative and absolute organ weights for both sexes and any of the groups except prostata weight which was absolutely and relatively higher in the HD recovery group as compared to the control group values. In absence of finding in the main study animals the toxicological relevance of this finding is difficult to assess and it may be consider as incidental, moreover as the variation is below 20%.
GROSS PATHOLOGY
There were no test substance-related macroscopic observations in either male or female rats.
HISTOPATHOLOGY
Histopathological changes seen at terminal sacrifice were few and all of them were considered to be incidental in origin and/or within the range of expected changes for rats of this age and strain kept under laboratory conditions. There was no indication of any test item-related effect on organs and tissues evaluated in this study.
Applicant's summary and conclusion
- Conclusions:
- The results from the evaluation of reproductive organs (organ weights of ovary, uterus with cervix, testis, epididymides, prostate with seminal vesicles and coagulating glands and the gross pathology and the histopathology of the reproductive organs (gonads, prostate and seminal vesicle, epididymides, uterus and vagina)) revealed no test substance related findings in the main study up to and including the highest tested dose of 1000 mg/kg bw/day.
- Executive summary:
In this Repeated Dose, 28-day Oral Toxicity Study according to OECD Guideline 407 (adopted 03 October 2008) and EU method B.7 (30 May 2008), the test item MDEA Esterquat C18 satd. suspended in Aqua ad injectionem (10 % w/w) as vehicle was orally administered in graduated doses to three groups of male and female rats (HsdRccHan: WIST) by gavage.
The main study included 4 groups (control, 62.5, 250, 1000 mg/kg bw) with each 5 male and 5 female animals and the recovery study included 2 groups (control, 1000 mg/kg bw) each with 5 male and 5 female animals.
All animals but one (male; 250 mg/kg bw group) treated with the test item MDEA Esterquat C18 satd. survived throughout the test period and were sacrificed on day 29 or day 43 for the recovery animals. The death of animal No. 25 was not test-item related and a gavage accident may have been the cause of death of this animal.
No test substance-related findings were detected or observed in clinical examinations, body weights, food consumption values, haematology, urinalysis, neurobehavior, clinical biochemistry or gross pathology evaluations, including organ weights of ovary, uterus with cervix, testis, epididymides, prostate with seminal vesicles and coagulating glands and the gross pathology and the histopathology of the reproductive organs (gonads, prostate and seminal vesicle, epididymides, uterus and vagina).
The NOEL is 1000 mg/kg bw/day in this study.
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.