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EC number: 287-090-7 | CAS number: 85409-23-0
- 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
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 28, 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- not applicable
- GLP compliance:
- no
- Limit test:
- no
Test material
- Test material form:
- liquid: viscous
- Remarks:
- Clear water-white viscous liquid
Constituent 1
- Specific details on test material used for the study:
- Test material: (Alkyl (C12-C18) dimethylethylbenzylammonium chloride as a.i.) in aqueous solution
Lot/Batch number: Notebook #1607-3684; Sample #676-09/L
Description: Clear water-white viscous liquid
Purity: 50% w/w a.i.
Stability: The a.i., ADEBAC, is hydrolytically and photolytically stable under the conditions of this study and its related quaternary ammonium compounds have been shown to be stable in aqueous, alcohol and alcohol/aqueous solutions for extended periods, e.g. at least five years under standard laboratory conditions.
Test animals
- Species:
- rat
- Strain:
- other: Female Wistar derived albino
- Details on test animals or test system and environmental conditions:
- -Individual mesh bottom cages in temperature controlled quarters
-Free access to food and fresh tap water
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Dose levels: 0, 5, 15 and 50 mg/kg bw/day (0, 2.5, 7.5 and 25 mg/kg bw/day a.i.)
- Details on mating procedure:
- Adult female rats were mated with young adult male and detection of the vaginal sperm plus was considered to occur on day 0 of gestation
- Duration of treatment / exposure:
- Days 6 - 15 of gestation
- Frequency of treatment:
- Once daily during exposure period
- Duration of test:
- Dams were scacrificed on day 20 of gestation
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Without test substance (Only vehicle - Water)
- Dose / conc.:
- 5 mg/kg bw/day
- Remarks:
- 2.5 mg/kg bw/day (a.i.)
- Dose / conc.:
- 15 mg/kg bw/day
- Remarks:
- 7.5 mg/kg bw/day (a.i.)
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- 25 mg/kg bw/day (a.i.)
- No. of animals per sex per dose:
- 22-37/group female rats
- Control animals:
- yes
- yes, concurrent no treatment
Examinations
- Maternal examinations:
- Clinical signs: Daily
Mortality: Daily
Bodyweight: Days 0, 6, 11, 15 and 20
Number of corpora lutea
Number of implantation and resorptions sites
Number of corpora lutea
Urogenital tract gross necropsy - Ovaries and uterine content:
- Not examined
- Fetal examinations:
- Body weight
Gross necropsy
Skeletal examinations - Two thirds of the foetuses were used for this examination
Visceral examinations - One third of the foetuses were used for this examination - Statistics:
- Confidence Belts for proportions with a confidence coefficient of 0.95 was used to compare the experimental and control groups. If the significance was not clearly definable, the probability of the occurrence was determined by the computation of exact probabilities.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not examined
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- 3 dams died in the 50 mg/kg/day test group.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no effects of treatment on gestational body weight.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Maternal developmental toxicity
- Number of abortions:
- not examined
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- not examined
- Early or late resorptions:
- not examined
- Dead fetuses:
- not examined
- Changes in pregnancy duration:
- not examined
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): not examined - Changes in number of pregnant:
- not examined
- Other effects:
- no effects observed
- Description (incidence and severity):
- Affects on gestation were not noted in any treatment group. Twelve females in the positive control group resorbed their uterine contents.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 15 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- mortality
- Remarks on result:
- other: i.e., equivalent to 7.5 mg a.i./kg bw/day
Maternal abnormalities
- Key result
- Abnormalities:
- effects observed, treatment-related
- Localisation:
- other: General toxicity - Mortality
- Description (incidence and severity):
- 3 dams in the 50 mg/kg bw/day test group died
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were observed in all treated group. Decreased weights were observed in the positive control group.
- Reduction in number of live offspring:
- not examined
- Changes in sex ratio:
- not examined
- Changes in litter size and weights:
- not examined
- Changes in postnatal survival:
- not examined
- External malformations:
- not examined
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- No treatment-related variations or malformations
- Visceral malformations:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No treatment-related variations or malformations
- Other effects:
- no effects observed
- Description (incidence and severity):
- No malformations
- Details on embryotoxic / teratogenic effects:
- No developmental toxicity including teratogenicity was observed at any dosage employed, as compared to the negative control group.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 50 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No developmental toxicity, including teratogenicity was observed at any dosage employed.
- Remarks on result:
- other: NOEL 25 mg a.i./kg bw/day
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
- Description (incidence and severity):
- No developmental toxicity, including teratogenicity was observed at any dosage employed.
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Under study conditions, for test substance, the NOEL for maternal toxicity and developmental toxicity were determined to be 15 mg/kg bw/day (7.5 mg/kg bw/day a.i.) and >50 mg/kg bw/day (25 mg a.i./kg bw/day) respectively.
- Executive summary:
A study was conducted to determine the developmental toxicity of test substance, C12-18 ADEBAC (active: 50%), according to a method equivalent or similar to OECD 414 guideline. 22-37 pregnant female Wistar rats/group were treated with test substance at concentrations of 0, 5, 15 and 50 mg/kg bw/day (0, 2.5, 7.5 and 25 mg a.i./kg bw/day) or aspirin (positive control) at 250 mg/kg bw/day. The dams were sacrificed at Day 20 and the foetuses were examined for visceral and skeletal variations and malformations. There were no treatment-related effects on the body weight or reproductive parameters. Increased mortality was observed at 50 mg/kg/day, however, this finding was not statistically significant. There were no treatment-related effects on foetal body weight or visceral/skeletal findings. In the positive control group, increased fetal resorption, decreased fetal weight and increase incidences of skeletal and soft tissue variations were observed. No developmental toxicity, including teratogenicity was observed at any dosage employed. Under study conditions, for test substance, the no observable effect level (NOEL) for maternal toxicity and developmental toxicity were determined to be 15 mg/kg bw/day (7.5 mg/kg bw/day a.i.) and >50 mg/kg bw/day (25 mg a.i./kg bw/day) respectively (Knickerbocker and Stevens, 1977).
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.
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