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EC number: 947-407-8 | CAS number: -
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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 from secondary source
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Screening-Level Hazard Characterization Monocyclic Aromatic Amines Category
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 009
- Bibliographic source:
- U.S. Environmental Protection Agency, Hazard Characterization Document , September, 2009
- Reference Type:
- secondary source
- Title:
- Reproductive toxicity of test material
- Author:
- NTRL report
- Year:
- 1 990
- Bibliographic source:
- NTRL report , 1990
- Reference Type:
- other: Authoritative database
- Title:
- Toxicological Study of Metam-Sodium (CAS No: 137-42-8)
- Author:
- HSDB
- Year:
- 2 018
- Bibliographic source:
- U.S. National Library of Medicine National Institutes of Health, Health & Human Services; 2018
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: EPA OTS 798.4900
- Principles of method if other than guideline:
- Reproductive and developmental toxicity study of test material was performed on Sprague Dawley rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- N,N-diethylaniline
- EC Number:
- 202-088-8
- EC Name:
- N,N-diethylaniline
- Cas Number:
- 91-66-7
- Molecular formula:
- C10H15N
- IUPAC Name:
- N, N-diethyl aniline
- Test material form:
- liquid
- Details on test material:
- - Name of test material: N,N-diethylaniline- Substance type: Organic- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Details on test animals and env. conditionsTEST ANIMALS- Source: Charles River Breeding Laboratories. Inc. Shaver Road Portage. Michigan 49081- Age at study initiation: female: Six weeks ,male : Seven weeks- Weight at study initiation: mean: 207grams(167.6-311.1g)- Fasting period before study:- Housing: Individually. except during the first week of the acclimation period (two females/cage) and mating. in stainless steel suspended cages with wire mesh floors.- Use of restrainers for preventing ingestion (if dermal): yes/no- Diet (e.g. ad libitum): Purina. Certified Rodent Chow No. 5002 (mash) fed ad libitum.- Water (e.g. ad libitum): Tap water delivered by automatic watering system, ad libitum (Elizabethtown Water Company).- Acclimation period:21 days ENVIRONMENTAL CONDITIONS- Temperature (°C):18.88-23.33°C- Humidity (%):26-68%- Air changes (per hr):- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle (7 AM to 7 PM) via automatic timerIN-LIFE DATES: From: To:
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Details on exposurePREPARATION OF DOSING SOLUTIONS:Test material dissolved in corn oil DIET PREPARATION- Rate of preparation of diet (frequency):No data available- Mixing appropriate amounts with (Type of food )- Storage temperature of food: No data availableVEHICLE- Justification for use and choice of vehicle (if other than water): corn oil - Concentration in vehicle: 0, 50,250,500mg/kg bw/day- Amount of vehicle (if gavage): 5ml/kg bw/day - Lot/batch no. (if required): No data available- Purity: No data available
- Details on mating procedure:
- Mated females were used
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 10 days ( from day 6 through day 15 of gestation )
- Frequency of treatment:
- daily
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 0, 50,250,500 mg/kg bw/day
- No. of animals per sex per dose:
- Total:1010 mg/kg bw/day:2450mg/kg bw/day:24250mg/kg bw/day:24500 mg/kg bw/day:29
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- Parental animals observation and examinationsCAGE SIDE OBSERVATIONS: yes DETAILED CLINICAL OBSERVATIONS: Twice daily (morning and afternoon) for signs of pharmacologic or toxicologic effects and mortality. In addition. eachfemale was given a detailed physical examination on Days 0. 10. 12. 15 and 20 of gestation. On Days 6. 10. 12 and 15 of gestation the examinations were given after dosing. Time schedule: twice daily BODY WEIGHT: YesTime schedule for examinations: Recorded on Days 0. 6. 10. 12, 15 and 20 of gestation.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes Recorded for the following intervals during gestation: Days 0 to 5. 6 to 10. 10 to 15 and 15 to 20. 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 / No / No data: No data availableWATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data Time schedule for examinations: OTHER:
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- All fetuses were given a gross examination for external malformations/variations to include observation for palatal defects. Subsequently. Each fetus was weighed and individually identified. The sex of each fetus was noted externally (ano-genital distance) and was confirmed by internal inspection of the gonads at subseqaent evaluation
- Postmortem examinations (parental animals):
- Postmortem examinations (Parent Animal)SACRIFICE: Day 20 of gestation using Lethal exposure to ether.GROSS NECROPSY: Complete gross postmortem examinations were performed on all mated females including those dying spontaneously or sacrificed in a moribund condition. External surface, all orifices, thecranial cavity, carcass, the external surface of the spinal cord and sectioned surfaces of the brain, nasal cavity and paranasal sinuses, the thoracic, abdominal and pelvic cavities and their viscera and the cervical tissues and organs were examined for all animals. The carcass of each female was discarded at the completion of the gross post-mortem evaluationHISTOPATHOLOGY / ORGAN WEIGHTSThe tissues indicated in Table [#] were prepared for microscopic examination and weighed, respectively. macroscopic examination was performed
- Postmortem examinations (offspring):
- Postmortem examinations (offspring)SACRIFICEApproximately one-half of the fetuses in each litter (alternating fetuses within the litter) were evaluated for soft tissue malformations/variations
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- In the 50mg/kg bw dose group three females were noted with excessive salivation during the physical evaluations. No other adverse effects of treatment at this dose level were noted from the physical evaluations.Rats in the 250mg/kg and 500mg/kg dose groups also had excessive lacrimation and staining of the skin/fur in the ano-genital region
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- No mortality occurred in the control. 50mg/kg and 250mg/kg dose groups. In the 500mg/kg dose group two females died and three females were sacrificed in a moribund condition (17.2 %mortality rate).
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- In the 50mg/kg bw dose group mean weight gains for the Day 6-15 treatment interval of gestation and for the Day 6-20 gestation interval using corrected Day 20 weights were lower than control (-14.3 %and -12.1%, respectively); however, these differences from control data were not statistically significant. In the 250mg/kg dose group. Mean weight gains for the Day 6-15 and 6-20 gestation intervals were lower than control (-19.0% and -16.4%, respectively); however, only for the Day 6-15 gestation interval did these data differ statistically from control data. In the 500mg/kg dose group mean weight gain data for the Day 6-15 and 6-20 gestation intervals were markedly lower than control (--71.4 % and- 56.8%, respectively) and these data differed statistically from control data.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- During the treatment period mean food consumption was lower than control in each of the treated groups. In the low-dose group, mean food consumption was significantly lower than control during the Day 6-10 gestation interval (-12.1%) but was comparable to control for the day 10-15 intervals. In the mid-dose group. Mean food consumption was significantly lower than control during both the Day 6-10 and 10-15 gestation intervals (-22.0% and -11.7%. respectively). Similarly, in the high-dose group. mean food consumption was significantly lower than control during both the Day 6-10 and 10-15 gestation intervals (-47.3% and -13.8%. respectively).
- 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:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- The pregnancy rate was 100% in 50mg/kg bw dose group. 95.8% (23/24 females) in the control and 250mg/kg bw dose groups and 96.6% (28/29 females) in the 500mg/kg bw dose group. No adverse effect of treatment was evident from pregnancy rate data.The mean number of corpora lutea and uterine implantations was considered comparable between the control and treated groups.The mean number of resorption sites per pregnant female was comparable between the controls. 50mg/kg bw and 250mg/kg bw dose groups. In the 500mg/kg bw dose group, the mean number of resorption sites was higher than control; however, this difference was not statistically significant.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- reproductive performance
- Remarks on result:
- other: No effects on reproductive performance
Target system / organ toxicity (P0)
- 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
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- The mean number of viable fetuses per pregnant female was comparable between the control and treated groups
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- mean fetal weight unaffected at 50mg/kg bw and 250mg/kg bw dose mean fetal weight statistically lower than control
- Food consumption and compound intake (if feeding study):
- not specified
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- Evaluation of fetuses recovered from treated group females for external, visceral and skeletal malformations indicated no adverse effect of treatment. At the 500mg/kg bw dose level, the incidence of fetuses with unossified sternebral elements (particularly the fifth and sixth sternebrae) was increased suggestive of a retardation in ossification.
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- viability
- mortality
- body weight and weight gain
- gross pathology
- Remarks on result:
- other: overall no developmental toxic effects observed
Target system / organ toxicity (F1)
- 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
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No Observed Adverse Effect Level (NOAEL) for reproductive and developmental toxicity was considered to be 250mg/kg bw .When female Sprague Dawley rats were treated with test material orally.
- Executive summary:
The reproductive and developmental toxicity study of test material was performed on mated female Sprague Dawley rats according EPA OTS 798.4900. The test material dissolved in corn oil and administered in dose concentration0, 50,250,500 mg/kg bw/day by oral gavage route from day 6 to 15 of gestation in dose volume 5ml/kg bw .The control, 50mg/kg and 250 mg/kg dose groups contained 24 females each; the 500mg/kg dose group contained a total of 29 females. All the animals were observedtwice daily for signs of pharmacologic or toxicologic effects and mortality. In addition, Each female was given a detailed physical examination on Days 0, 10,12, 15 and 20 of gestation. On Days 6, 10, 12 and 15 of gestation the examinations were given after dosing. Body weight recorded on Days 0, 6, 10,12, 15 and 20 of gestation. Food Consumption recorded for the following intervals during gestation Days 0 to 5, 6 to 10 ,10 to 15 and 15 to 20. Females were sacrificed on Day 20 of gestation and given a gross postmortem examination. Ovaries were evaluated for number of corpora lutea and uterine implantation data were evaluated for number of live, dead and resorbed fetuses. Fetuses recovered at this time were weighed,sexed and evaluated for external malformations; approximately one-half of the fetuses in each litter (alternating fetuses Within the litter) were processed for soft tissue examination (micro dissection procedure) and the remaining fetuses were processed for skeletal evaluations (Alizarin Red S).
Some maternal toxicity was evident at each dose level. 50mg/kg bw dose group females experienced depressed weight gain during the treatment period; however, these data did not differ statistically from control. Mean food consumption for the Day 6-10 interval of treatment in the 50mg/kg bw dose group was statistically lower than control and three 50mg/kg bw dose females experienced excessive salivation during the treatment period. Similar manifestations of maternal toxicity were seen at the 250mg/kg bw and 500mg/kg bw dose levels; however, the effects were more extreme. Physical examination of females in the 250mg/kg bw and 500mg/kg bwdosegroups revealed an increased incidence of females with excessive salivation, staining of the skin/fur in the ano-genital area and excessive lacrimation. At the 500mg/kg bw dose level, two females died and three females were sacrificed in a moribund condition (mortality rate:l7.2%)no mortality occurred in the 50mg/kg bw or 250mg/kg bw dose groups. No adverse effect of treatment was evident from uterine implantation Mean fetal weight and fetal sex distribution were unaffected by treatment at the 50mg/kg bw or 250mg/kg bw dose levels. In the 500mg/kg bw dose group, mean fetal weight data as a composite for both sexes and when distinguished by sex, were statistically lower than control. Evaluation of fetuses recovered from treated group females for external, visceral and skeletal malformations indicated no adverse effect of treatment. At the 500mg/kg bw dose level, the incidence of fetuses with unossified sternebral elements (particularly the fifth and sixth sternebrae) was increased suggestive of a retardation in ossification. HenceNo Observed Adverse Effect Level (NOAEL) for reproductive and developmental toxicity was considered to be 250mg/kg bw .When femaleSprague Dawley rats were treated withtest materialorally.
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