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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 219-983-4 | CAS number: 2591-76-6
- 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:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- exposure only at GD10 or GD10+11.
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryotoxicity in Rats and Rabbits from Cutaneous Application of Amide-Type Solvents and Substituted Ureas.
- Author:
- Stula E.F. & Krauss W.C.
- Year:
- 1 977
- Bibliographic source:
- Toxicology and Applied Pharmacology 41, 35-55
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N-bis(2-methylpropyl)formamide
- EC Number:
- 219-983-4
- EC Name:
- N,N-bis(2-methylpropyl)formamide
- Cas Number:
- 2591-76-6
- Molecular formula:
- C9H19NO
- IUPAC Name:
- N,N-bis(2-methylpropyl)formamide
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): N,N-de(n-butyl)formamide
- Purity: Commercial grade with less than 2.0 % impurities.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 220 - 250 g
- Housing: Singly in suspended stainless steel wire sages
- Diet: Purina Laboratory Chow, ad libitum
- Water: ad libitum
Administration / exposure
- Route of administration:
- dermal
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: The test substance was applied on the intact skin over the thoracic vertebral area after the hair was removed with a hair clipper
TEST MATERIAL
- Amount(s) applied: Usually the volume of a single dose was less than 0.5 mL - Details on mating procedure:
- No details given.
- Duration of treatment / exposure:
- The test item was applied to the skin of pregnant rats during the period of fetal organogenesis.
- Frequency of treatment:
- On day 10 or at day 10 + 11 of gestation.
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
On day 10 of gestation: 600 mg/kg and 1200 mg/kg; On day 10 + 11 of gestation: 600 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 5 - 9 (see table 1 under "Any other information on results incl. tables")
- Control animals:
- yes
Examinations
- Maternal examinations:
- - Body weight change
- Approximate lethal dose (ALD) - Ovaries and uterine content:
- In addition to gross examination of fetuses and uteri, the following determinations were recorded:
- number of live fetuses
- number of dead fetuses
- number of implantation sites
- number of resorption sites - Fetal examinations:
- - fetal weight
- fetal crown-rump length
- 2/3 of the fetuses from each litter were stained with alizarin red for detection of skelatal abnormalities.
- The remaining fetuses were fixed in Bouin's fluid and examined for visceral abnormalities.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
- Approximate lethal dose: 1500 mg/kg
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
- Embryomortality was found only at a level in rats that was lethal for the mother (33 % embryomortality at a dose of 1200 mg/kg)
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1: Embryotoxic effects of the test item applied to skin of pregnant rats
Number of pregnant rats in group |
Daily dose [mg/kg] |
Gestation days applied |
48-h Mother body weight change (%) |
Embryomortality (%) |
Average fetal weight (g) |
Fetal abnormalities |
9 |
600 H2O Control |
10 |
+2b |
7 |
2.6 |
- |
8 |
600 (1/2) |
10 |
0b |
7 |
2.5 |
- |
4a |
1200 (1/1) |
10 |
-5b |
33 |
2.7 |
- |
6 |
600 H2O Control |
10 + 11 |
+3 |
9 |
2.1 |
- |
5 |
600 (1/2) |
10 + 11 |
-4 |
8 |
1.6 |
- |
anot included were 1/5 pregnant mothers that died; 3/3 nonpregnant females survived this dosage
b24-h mother body weight change
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.
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.