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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01.03.1989 - 04.04.1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- 24.02.1987, before latest revision 9 Oct 2017.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Version / remarks:
- November 1984
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: 230688
- Expiration date of the lot/batch: 06.08.1989
- Purity test date: 97.0%
- slightly viscous, transparent liquid
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: under light closure at room temperature
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Bot:WISW (SPF-CPD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Paderborn
- Age at study initiation: male 9 weeks, female >= 16 weeks
- Weight at study initiation: male 211 - 231 g, female 219 - 233 g
- Housing: Makrolon cages Type III, during testing Makrolon cages Type II;
wooden granules Type S 8/15, Rettenmaier & Son
- Historical data: available
- Diet: Altromin 1324 ad libitum
- Water ad libitum:
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22° ± 2° C
- Humidity (%): ca. 50
- Air changes (per hr): 10 per hr
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: cellulose unspecified
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal skin
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
male 500 mg/kg Kgw.3.57 - 3.77 mg/cm2
1000 mg/kg Kgw.:7.03 - 7.40 mg/cm2
female 500 mg/kg Kgw.:3.70 - 3.87 mg/cm2
1000 mg/kg Kgw.: 7.47 - 7.77 mg/cm2
- For solids, paste formed: yes
- Duration of exposure:
- 24 h
- Doses:
- 500, 710, 1000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Clinical signs including body weight day 4, day 8 and then weekly
- Other examinations performed: clinical signs, body weight, histopathology.
behavior, nwervous system, posture,
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 790 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 730 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 500 mg/kg: no mortalityy
710 mg/kg 1 male and 2 female
1000 mgL/kg: 5 male and 5 female - Clinical signs:
- other: Apathy, difficult breathing, decreased motility, partly tumbling gait, low reflexes, occasionally shaved fur, salivation and spread posterior extremities Only female animals: erythema, brown discolouration, scabbing, hardening and incrustations.
- Gross pathology:
- Blown lungs, partially dark, spotty, liver partly pale, dark, single spleen partly pale, kidneys partly pale, bladder bulging with partly
bloody urine filled and occasionally ulcer-like ffoci in the glandular stomach.
Any other information on results incl. tables
Table 1: Results of acute dermal toxicity study in rats
Group | Dose (mg/kg bw) | Toxicol. results* | Duration of signs | Time of death | Mortality (%) |
rat - male | |||||
1 | 500 | 0/5/5 | 2h - 2d | -- | 0 |
2 | 710 | 1/5/5 | 2h - 3d | 5h | 20 |
3 | 1000 | 5/5/5 | 2h - 1d | 5h - 1d | 100 |
rat - female | |||||
1 | 500 | 0/5/5** | 2h - 4d | -- | 0 |
2 | 710 | 2/5/5** | 45´ - 8d | 7h | 40 |
3 | 1000 | 5/5/5** | 40´ - 2d | 1d - 2d | 100 |
* No. of dead animals/animals with symptoms/animals treated
** Dermal findings were not considerd in this table.
LD50, rat - male: ca. 790 mg/kg bw
LD50, rat - female: ca. 730 mg/kg bw
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The study on acute dermal toxicity of N,N-Dibutylformamide in rats resulted in a LD50 value of 790 mg/kg for male animals and 730 mg/kg for female animals, A classification according to the CLP Regulation (EC) No. 1272/2008 (EU-GHS: Cat. 3) is required.
- Executive summary:
In a study according to OECD 402 the unchanged test item was applied on the back of male and female Wistar rats for 24 hours under occlusive conditions. Three doses were tested, 500, 710 and1000 mg/kg bw. Following application, the animals were observed for a period of 14 days and clinical signs and body weight was recorded. All doses tested resulted in symptoms; apathy, difficulty breathing, reduced motility, sometimed tumbling gait, slight reflexes and occasionally dusty fur, salivation and spreas extremities. The effect started later about 1 to 2 hours and disappeared on the second, at the latest of the 8th day of the study. Ihe lowest dose used females showed skin symptoms like reddening, brown discoloration, scrabbing, hardening and crusting. Death occured in both sexes from 710 mg/kg bw on. The LD50 for males was 790 mg/kg and females was 730 mg/kg
Regarding the results of the dermal test classification according to Regulation (EC) No.1272/2008 (EU-GHS: Cat. 3) is required.
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