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EC number: 212-090-0 | CAS number: 761-65-9
- 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:
- key study
- Study period:
- 1983-04-25 to 1983-10-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- N,N-dibutylformamide
- EC Number:
- 212-090-0
- EC Name:
- N,N-dibutylformamide
- Cas Number:
- 761-65-9
- Molecular formula:
- C9H19NO
- IUPAC Name:
- N,N-dibutylformamide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 82/330
- Purity test date: 1982-10-26
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr . K . THOMAE GmbH, Biberach, Germany
- Age at study initiation: 27-69 weeks
- Weight at study initiation: Mean body weight of the animals: 2.55 kg
- Housing: Singly housing in stainless steel cages (area: 2860 cm2).
- Diet: standardized animal laboratory diet (about 130 g/animal/day)
- Water: tap water (about 500 mL/animal/day).
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes: air-conditioned rooms
- Photoperiod: 12 h light and 12 h darkness
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The test substance was emulgated in CMC (basis: weight/volume). During the period of treatment the suspensions were prepared daily, shortly before the beginning of treatment.
The concentration of the suspensions was 3.1% for the 62 mg/kg bw/day dose, 6.25% for the 125 mg/kg bw/day dose and 12.5% for the 250 mg/kg bw/day dose. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Concentration of the emulsion was tested twice.
- Details on mating procedure:
- - Impregnation procedure: artificial insemination
One hour prior to insemination 40 I.U. of Primogonyl R (= chorionic gonadotropin, trade product of SCHERING AG, Berlin/Bergkamen, FRG, dissolved in 1 mL of physiological saline solution) were injected intravenously (ear vein) into each animal. The day of insemination was designated day 0 of pregnancy, the following day the first day post insemination (p.i.). - Duration of treatment / exposure:
- 13 successive days (from the 6th -18th day post insemination)
- Frequency of treatment:
- daily at the same time of day (in the morning). The amount of test substance to be administered at each dose level per kg body weight was contained in a volume of 2 mL.
- Duration of test:
- from the 6th -18th day post insemination
Doses / concentrationsopen allclose all
- Dose / conc.:
- 62 mg/kg bw/day
- Dose / conc.:
- 125 mg/kg bw/day
- Dose / conc.:
- 250 mg/kg bw/day
- No. of animals per sex per dose:
- 62 mg/kg bw/day; 22
125 mg/kg bw/day: 14
250 mg/kg bw/day: 22 - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: In a preliminary study (doses: 31, 62, 125 and 250 mg/kg bw/day), rabbits were orally administered from day 6 - 18 p.i. Only at a dose of 250 mg/kg bw/day a slight till questionable embryolethality was demonstrated. Thus, 250 mg/kg was selected as the high dose for the main study. Supportingly, the acute oral LD50 in rats is about 1050 mg/kg bw/d (BASF SE, 1979), and mortality of pregnant rats is described after single dermal appllication of 1200 mg/kg DBF at GD10 (Stula et al., 1977). Therefore, the MTD after repeated exposure for rats is expected to be well below 500 mg/kg.
- Details on control animals: A further group of animals was treated with a 0.5% aqueous CMC formulation and treated and investigated in the same way
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Three times in the week
FOOD CONSUMPTION AND COMPOUND INTAKE : Yes
- 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
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 29
- Organs examined: Ovaries and uterine
Animals were sacrificed by rapid intravenous administration (ear vein) of 1 mL/kg + 1 mL Nembutal R (= pentobarbital sodium, 60 mg/mL, trade product of ABBOTT GmbH). - 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:
- - External examinations: Yes, on day 29
- Soft tissue examinations: Yes
- Skeletal examinations: Yes
The length and weight of the fetuses as well as the weight of the placentas were determined.
All fetuses were eviscerated, their sex was determined, and the organs were examined macroscopically. Subsequently the fetuses were X-rayed for the evaluation of the skeletons. After being X-rayed, the heads were fixed in BOUIN's solution, and after fixation they were processed and evaluated according to the method of WILSON. - Statistics:
- method of WILSON
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 62 and 125 mg/kg bw /day: non-treatment related diarrhoe and conjunctivitis
The dose of 250 mg/kg bw/day showed symptoms, which were related to the test substance administration. Following symptoms were oberseved: Mydriasis, tachycardia, uncertain gait, apathy. - Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- From days 5 to 6 post insemination a significant increase in food consumption was observed for the highest dose group compared to the control group.
- Food efficiency:
- 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:
- no effects observed
- Description (incidence and severity):
- no significant differences in weight of uteri
- Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- control: one animal with changes in liver morphology, 4 animals with cysts in uterine horns
62 mg/kg bw/day: 5 animals with cysts in uterine horns
125 mg/kg bw/day: 2 animals with cysts in uterine horns
250 mg/kg bw/day: 4 animals with cysts in uterine horns - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Maternal developmental toxicity
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- No changes in numbers of corpora lutea, dead or alive implants, preimplantative lost of eggs was observed. The conception rate was between 77.78 and 92.86 %.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 125 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Abnormalities:
- not examined
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Reduction in number of live offspring:
- no effects observed
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: prenatal developmental toxicity including teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
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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