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EC number: 205-319-0 | CAS number: 138-24-9
- 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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data from secondary source
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Robust Summaries & Test Plans for test material Joint Venture HPV Chemicals Challenge
- Author:
- Consumer Specialty Products Association (CSPA)
- Year:
- 2 011
- Bibliographic source:
- Robust Summaries & Test Plans for test material, Joint Venture HPV Chemicals Challenge 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: U. S. EPA FIFRA 83-3
- Principles of method if other than guideline:
- Reproductive and developmental toxicity study oftest material was performed on Sprague Dawley rats.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides
- EC Number:
- 270-325-2
- EC Name:
- Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides
- Cas Number:
- 68424-85-1
- Molecular formula:
- Unspecified
- IUPAC Name:
- Alkyl dimethyl benzyl ammonium chloride
- Details on test material:
- - Name of test material (as cited in study report):Alkyl dimethyl benzyl ammonium chloride
- Molecular formula:unspecified
- Molecular weight :368.0448g/mol
- Substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- No data available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Details on exposure
PREPARATION OF DOSING SOLUTIONS: test material dissolved in Milli-Q water
DIET PREPARATION
- Rate of preparation of diet (frequency):No data available
- Mixing appropriate amounts with (Type of food)
- Storage temperature of food: No data available
VEHICLE
- Justification for use and choice of vehicle (if other than water):
- Concentration in vehicle:10, 30 and 100 mg/kg/day
- Amount of vehicle (if gavage): 5 ml/kg/day.
- Lot/batch no. (if required): No data available
- Purity: No data available - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- timed-pregnant female rats
- Duration of treatment / exposure:
- 10 days (Days 6 through 15 of gestation)
- Frequency of treatment:
- Daily
- Duration of test:
- Day 21 of gestation
Doses / concentrations
- Remarks:
- 0,10, 30 and 100 mg/kg/day
- No. of animals per sex per dose:
- Total:100
0 mg/kg/day:25 female
10 mg/kg/day:25 female
30 mg/kg/day:25 female
100mg/kg/day:25 female - Control animals:
- yes
- Details on study design:
- - Dose selection rationale: A range-finding study was conducted to determine dose levels for the definitive developmental toxicity study. Five groups of five timedpregnant female rats each were dosed with test material at concentrations of 25, 50, 100, 200 or 400 mg/kg/day by oral gavage on gestation days (GD) 6 through 15.
Examinations
- Maternal examinations:
- Parental animals observation and examinations
CAGE SIDE OBSERVATIONS: yes
DETAILED CLINICAL OBSERVATIONS: Yes
Time schedule: female rats were observed for mortality twice daily, clinical
signs of toxicity daily (twice daily during dosing)
BODY WEIGHT: Yes
Time schedule for examinations: maternal body weights and food consumption were
measured at varying intervals.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes Food consumption was determined weekly.
Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / No data: No data available
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
Time schedule for examinations: - 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
- Other: - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- Quantitative continuous variables were compared for the three treatment groups and the control group by use of Levene’s test for equality of variances, analysis of variance (ANOVA), and t-tests. Nonparametric data were evaluated using the Kruskal-Wallis test, followed by the Mann- Whitney U test when appropriate. Incidence data were compared using the Fisher’s Exact Test.
- Indices:
- No data available
- Historical control data:
- No data available
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment-related clinical signs included perioral wetness in 67% of dams in the 100 mg/kg group. Audible respiration during and subsequent to the treatment period also was observed in three dams in the 100 mg/kg group.
One dam in this group exhibited dehydration, unkempt appearance, loose feces, urine stains and perioral wetness. Audible respiration was observed in two dams in the 30 mg/kg group. One of these dams also exhibited urine stains, gasping, perinasal encrustation, loose feces and perioral wetness. No treatment-related clinical signs were observed in animals in the 10 mg/kg group during or subsequent to treatment. - Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no effects of treatment on gestational body weight and weight gain, corrected body weight.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food consumption was reduced for days 6 - 9 of gestation in the 30 and 100 mg/kg groups.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- There were no effects of treatment on gravid uterine weight.
- Gross pathological findings:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- not specified
- 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:
- not specified
- Changes in pregnancy duration:
- not specified
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Other effects:
- not specified
- Details on maternal toxic effects:
- Pregnancy rate was equivalent among groups and ranged from 84 to 100%. Twenty-one to 25 live litters were available for evaluation from each group. There were no statistically significant differences between treated and control animals in gestational parameters
(including total number of implantations, number of viable and nonviable implants per litter).
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- body weight and weight gain
- changes in number of pregnant
- clinical signs
- early or late resorptions
- food consumption and compound intake
- maternal abnormalities
- number of abortions
- pre and post implantation loss
- total litter losses by resorption
- Remarks on result:
- other: No effects observed
Maternal abnormalities
- Abnormalities:
- not specified
- Localisation:
- not specified
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- There were no statistically significant differences between treated and control fetal body weights per litter
Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified - Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- fetal/pup body weight changes
- external malformations
- skeletal malformations
- visceral malformations
- Remarks on result:
- other: No developmental toxic effects were observed
Fetal abnormalities
- Abnormalities:
- not specified
- Localisation:
- other: not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Relation to maternal toxicity:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for reproductive and developmental toxicity was considered to be 100mg/kg bw/day. When female SpragueDawley rats were treated with test material orally.
- Executive summary:
The reproductive and developmental toxicity of test material was performed ontimed-pregnant female Sprague-Dawley rats. The test material was dissolved in Milli-Q water in dose concentration 10, 30 and 100 mg/kg/day and adminstered in dose volume 5 ml/kg orally by gavage from Days 6 through 15 of gestation. The dose concentration selected on the bases of dose range finding atconcentrations of 25, 50, 100, 200 or 400 mg/kg/day by oral gavage on gestation days (GD) 6 through 15.study.In main study,three groups of 25 timed-pregnant female rats each were dosed group while a control group of 25 timed-pregnant rats received water. Administered dose volumes of water or aqueous solutions of test material were based on the individual dam’s body weight on GD 6 and a constant volume of 5 ml/kg/day. Concentrations were adjusted for percentactive ingredient. Throughout the study, (GD 0 - 21), female rats were observed for mortality twice daily, clinical signs of toxicity daily (twice daily during dosing) and maternal body weights and food consumption were measured at varying intervals. At scheduled sacrifice on GD 21, a gross necropsy was performed on all dams. In addition, the dams were evaluated for body weight, liver and gravid uterine weight, number of corpora lutea, and number and status of implantation sites. All live fetuseswere dissected from the uterus weighed and examined for external malformation and variations and gender determinations. Approximately one-half of the live fetuses in each litter were examined for thoracic and abdominal visceral abnormalities. These fetuses were decapitated and their heads were fixed in Bouin’s solution for examination of craniofacial structures by serial sectioning. Intactfetuses (approximately one-half) were processed for skeletal staining with alizarin red S and examined for skeletal malformations and variations.
Treatment-related clinical signs included perioral wetness in 67% of dams in the 100 mg/kg group. Audible respiration during and subsequent to the treatment period also was observed in three dams in the 100 mg/kg group. One dam in this group exhibited dehydration, unkempt appearance, loose feces, urine stains and perioral wetness. Audible respiration was observed in two dams in the 30 mg/kg group. One of these dams also exhibited urine stains, gasping, perinasal encrustation, loose feces and perioral wetness. No treatment-related clinical signs were observed in animals in the 10 mg/kg group during or subsequent to treatment. Food consumption was reduced for days 6 - 9 of gestation in the 30 and 100 mg/kg groups. There were no effects of treatment on gestational bodyweight and weight gain, corrected body weight or gravid uterine weight. Pregnancy rate was equivalent among groups and ranged from 84 to 100%. Twenty-one to 25 live litters were available for evaluation from each group. There were no statistically significant differences between treated and control animals in gestational parameters (including total number of implantations, number of viable and nonviable implants per litter). There were no statistically significant differences betweentreated and control fetal body weights per litter or in the incidences of external, visceral or skeletal malformations or variations.HenceNo Observed Adverse Effect Level (NOAEL) for reproductive and developmental toxicity was considered to be 100mg/kg bw/day. When female Sprague Dawley rats were treated with test material orally.
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