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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-792-3 | CAS number: 2235-46-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from Auotharized database
Data source
Reference
- Reference Type:
- other: Auotharized database
- Title:
- Repaeted dose oral toxicity study of test chemical
- Author:
- HSDB
- Year:
- 2 018
- Bibliographic source:
- Hazardous Substances Data Bank
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Repaeted dose oral toxicity study of test chemical in mice
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- N,N-diethyl-m-toluamide
- EC Number:
- 205-149-7
- EC Name:
- N,N-diethyl-m-toluamide
- Cas Number:
- 134-62-3
- Molecular formula:
- C12H17NO
- IUPAC Name:
- Diethyltoluamide
- Details on test material:
- - IUPAC Name: N,N-diethyl-m-toluamide- InChI: 1S/C12H17NO/c1-4-13(5-2)12(14)11-8-6-7-10(3)9-11/h6-9H,4-5H2,1-3H3- Smiles: c1(C(=O)N(CC)CC)cc(ccc1)C- Molecular formula :C12H17NO- Molecular weight :191.2723 g/mol- Substance type:Organic- Physical state:Liquid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- other: Diet
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Test chemical was incorporated into the diet. DIET PREPARATION- Rate of preparation of diet (frequency):- Mixing appropriate amounts with (Type of food):- Storage temperature of food:VEHICLE- Justification for use and choice of vehicle (if other than water): diet - Concentration in vehicle: 0, 300, 1000, 3000, 6000, and 10,000 mg/kg/day
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 3 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 6 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Total: 1800 mg/kg/day: 15 male, 15 female 300 mg/kg/day: 15 male, 15 female1000 mg/kg/day: 15 male, 15 female3000 mg/kg/day: 15 male, 15 female6000 mg/kg/day: 15 male, 15 female10,000 mg/kg/day: 15 male, 15 female
- Control animals:
- yes
- Details on study design:
- not specified
- Positive control:
- not specified
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes - Time schedule:No data- Cage side observations checked in table [No.?] were included.: No dataDETAILED CLINICAL OBSERVATIONS: No data- Time schedule:No dataBODY WEIGHT: Yes - Time schedule for examinations:No dataFOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes - Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes HISTOPATHOLOGY: Yes
- Other examinations:
- not specified
- Statistics:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No treatment-related clinical signs were observed in treated mice
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- When treated with 3000 mg/kg bw, decreased body weight gain were observed in animals
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on food consumption were observed in treated mice.
- 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:
- effects observed, non-treatment-related
- Description (incidence and severity):
- When treated with 1000 mg/kg bw, increase Absolute and relative liver weights were observed in males and females mice. When treated with 300 mg/kg bw, increase Absolute and relative liver weights were observed in female mice. Increased liver weights and the corresponding hypertrophy were considered to be adaptive changes rather than an indication of systemic toxicity.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects on gross pathology were observed in treated mice.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- When treated with 3000 mg/kg bw, Multifocal hepatocellular hypertrophy was observed at high incidence in males and females mice. When treated with 1000 mg/kg bw, Multifocal hepatocellular hypertrophy was observed at a lower incidence in females mice. Hypertrophy was considered to be adaptive changes rather than an indication of systemic toxicity.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- Due to rejection of the treated diets, the 6000 and 10,000 mg/kg/day dose groups were discontinued after two weeks.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- food consumption and compound intake
- gross pathology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- Remarks on result:
- other: No effect observed
Target system / organ toxicity
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 1000 mg/kg bw when CD-1 male and female mice were treated with test chemical orally in diet for 90 days.
- Executive summary:
In repeated dose oral toxicity study,CD-1 male and female mice were treated with test chemical in the concnetration of 0, 300, 1000, 3000, 6000, and 10,000 mg/kg/day orally in diet for 90 days. No treatment-related clinical signs or effects on food consumption were observed in treated mice.Decreased body weight gain were observed in animals at 3000 mg/kg bw.Increase Absolute and relative liver weights were observed in males and females mice at 1000 mg/kg bw. Increase Absolute and relative liver weights were observed in female mice at 300 mg/kg bw.Increased liver weights were considered to be adaptive changes rather than an indication of systemic toxicity. In addition, No treatment-related effects on gross pathology were observed in treated mice. Multifocal hepatocellular hypertrophy was observed at high incidence in males and females mice at 3000 mg/kg bw. Multifocal hepatocellular hypertrophy was observed at a lower incidence in females mice at 1000 mg/kg bw. Hypertrophy was considered to be adaptive changes rather than an indication of systemic toxicity. Therefore, NOAEL was considered to be 1000 mg/kg bw when CD-1 male and female mice were treated with test chemical orally in diet for 90 days.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)