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EC number: 944-968-0 | 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Toxicity to Reproduction
Based on data from a 90 -day dog study, in which no overt toxic effects were evident that might have impacted reproductive organs, and a developmental toxicity study in the rat, in which no direct effects of treatment were noted on the pregnancies or their outcome, it may be predicted from this that (analogue read-across) Ninol CAA would share a similar toxicity profile.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because a pre-natal developmental toxicity study is available
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Studies used in this section were conducted with a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyl-dodecanamide and N,N-dimethyl-hexanamide). It is assumed that, due to the fact that a high amount in the mixture was N,N-dimethyl-decanamide and the rest of the mixture are homologues with a lower and higher molecular weight, the mixture has the similar toxicological behaviour than pure N,N-dimethyldecanamide.
No independent studies for toxicity to fertility are available.
However a 90 days repeated dose studies with a mixture of a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide in beagle dogs via gavage (40, 200 and 1000 mg/kg bw/d; Bayer 2000, J. Ruf) reported no relevant findings that would lead to a concern for reproductive toxicity in either the male or female.
It is assumed that a reproductive screening study or two generation study does not need to be conducted as results from a developmental toxicity study and a subchronic toxicity study did not reveal any reason of concern for offspring and for parent animals with respect to developmental toxicity or fertility.
Key study assignment:
No key study is assigned for this endpoint.
Short description of key information:
No effects on fertility are expected.
Effects on developmental toxicity
Description of key information
Developmental Toxicity
The test sunstance was administered orally by gavage, once daily, to mated female Wistar rats at dosages of 50, 150 or 450 mg/kg body weight/day from day 6 through to day 15 post coitum in order to assess the effects on embryonic and fetal development.
In the dams at 450 mg/kg body weight/day, severe clinical signs of reaction to treatment, reduced food consumption and reduced body weight gain were observed. Additionally, at this dose level slightly increased post-implantation loss, reduced mean fetal body weights, an increased incidence of fetuses with common abnormal skeletal findings and retardations in skeletal development were noted.
At 150 mg/kg body weight/day, there was a slight reduction in food consumption during the dosing period. At this dose level no effects on the maternal reproduction parameters or on the fetal parameters were noted.
External and visceral examination of the fetuses, did not reveal any treatment related effects up to and including the dose level of 450 mg/kg body weight/day.
Based on these results, the no-observed adverse effect level for the maternal organism was considered to be 50 mg/kg body weight/day and for the fetal organism 150 mg/kg body weight/day. Under the conditions described in this study, test substance did not reveal any teratogenic potential up to and including the highest dose level of 450 mg/kg body weight/day.
It may be predicted from this that (analogue read-across) Ninol CAA would share a similar toxicity profile.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. / Wolferstrasse 4 / CH 4414 Fullinsdorf / Switzerland
- Age at study initiation(pairing): 11 week minimum
- Weight at study initiation (day 0 post coitum): 179-226 g
- Housing: housed under standard laboratory conditions, housed individually in Macrolon cages(type-3) with wire mesh
tops and standardised granulated softwood bedding (Lignocel, Schill AG, CH 4132
Muttenz / Switzerland)
- Diet (e.g. ad libitum): ad libitum; Pelleted standard Kliba 343 rat/mouse maintenance diet ("Kliba", Klingentalmuehle AG, CH 4303 Kaiseraugst/Switzerland)
- Water (e.g. ad libitum):Tap water was available ad libitum
- Acclimation period: From July 27 to August 6, 1990 under test conditions, after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3°C
- Humidity (%): 40-70%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light):12 hours artificial fluorescent light/12 hours dark with background music (Schweizerischer Telefonrundspruch) played at a centrally defined low volume for at least 8 hours during the light period - Route of administration:
- oral: gavage
- Vehicle:
- other: Bi-distilled water with 0.5% Cremophor (BASF)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The mixtures of the test article and vehicle were prepared daily before administration. The test substance was weighed into a glass beaker on a tared precision balance (Mettler PE 360) and the vehicle added (w/w). The mixtures were prepared using a homogenizer. During the daily administration period, homogeneity was maintained using a magnetic stirrer.
The test article was administered orally, by gavage, once daily in the morning from day 6 through to day 15 post coitum. All groups received a dose volume of 10 ml/kg body weight, with a daily adjustment of the individual volume to the actual body weight. Control animals were similarly dosed with the vehicle alone
VEHICLE
- Justification for use and choice of vehicle (if other than water): common vehicle
- Concentration in vehicle: 5mg/ml, 15mg/ml, 45mg/ml - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Photometric analytical verification (UV/Vis)
Concentrations (5, 15, 150 mg/ml) and stability in bidestilled water with 0.5% Cremophor was verified.
Result: Recovery between 99.4 and 103.8%
Homogeneity varies from -4 to + 5% - Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1
- Length of cohabitation: overnight
- Further matings after two unsuccessful attempts: no information
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- from day 6 through to day 15 post coitum
- Frequency of treatment:
- once daily in the morning
- Duration of test:
- 21 days (from successful mating to termination, excluding acclimatisation etc)
- Remarks:
- Doses / Concentrations:
50mg/kg bw
Basis:
nominal conc.
in bidestilled water with 0.5% Cremophor - Remarks:
- Doses / Concentrations:
150mg/kg bw
Basis:
nominal in water
in bidestilled water with 0.5% Cremophor - Remarks:
- Doses / Concentrations:
450mg/kg bw
Basis:
nominal conc.
in bidestilled water with 0.5% Cremophor - No. of animals per sex per dose:
- 25 mated female rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: Dosages were based on the results of the dose range-finding study
(RCC Project 274972). - Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations checked in table were included. Signs of moratlities reaction to treatment and of ill health were observed.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: daily recorded from day 0 to 21
FOOD 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: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 21
- Organs examined: Post mortem examination, including gross macroscopic examination of all internal organs, with emphasis on the uterus, uterine contents, position of fetuses in the uterus and number of corpora lutea, was performed and the data recorded - 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 (embryonic resoption): Yes
- Number of late resorptions (fetal resorption): Yes
- Number of Pre-Implantation loss: yes
- Number of Post-Implantation loss: yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- Univariate one-way analysis of variance was used to assess the significance of intergroup differences.
If the variables could be assumed to follow a normal distribution, the Dunnett-test (many-one t-test), based on a pooled variance estimate, was
applied for the comparison between the treated groups and the control group.
The Steel-test (many-one rank test) was applied when the data could not be assumed to follow a normal distribution.
Fisher's Exact test for 2x2 tables was applied if the variables could be dichotomized without loss of information. - Indices:
- according to guideline
- Historical control data:
- Historical Reproduction Data and Spontaneous Abnormal Findings of Wistar/HAN Rats (WIST, Outbred, SPF Quality) from 1987, 1988 and 1989
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
The dams at 450 mg/kg body weight/day group showed severe clinical signs of reaction to treatment, reduced food consumption and reduced body weight gain.
Additionally, at this dose level slightly increased post-implantation loss, reduced mean fetal body weights, an increased incidence of fetuses with common abnormal skeletal findings and retardations in skeletal development were noted - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 - < 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
In the dams at 450 mg/kgdose level slightly increased post-implantation loss, reduced mean fetal body weights, an increased incidence of fetuses with common abnormal skeletal findings and retardations in skeletal development were noted.
External and visceral examination of the fetuses, did not reveal any treatment related effects up to and including the dose level of 450 mg/kg body weight/day - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 150 - < 450 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: No adverse effects
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 450 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: No adverse effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Under the conditions described in this study the test substance did not reveal any teratogenic potential up to and including the highest dose level of
450 mg/kg body weight/day. No-observed adverse effect level for the maternal organism was considered to be 50 mg/kg body weight/day and for the fetal organism 150 mg/kg body weight/day - Executive summary:
The test substance was administered orally by gavage, once daily, to mated female Wistar rats at dosages of 50, 150 or 450 mg/kg body weight/day from day 6 through to day 15 post coitum in order to assess the effects on embryonic and fetal development.
In the dams at 450 mg/kg body weight/day, severe clinical signs of reaction to treatment, reduced food consumption and reduced body weight gain were observed. Additionally, at this dose level slightly increased post-implantation loss, reduced mean fetal body weights, an increased incidence of fetuses with common abnormal skeletal findings and retardations in skeletal development were noted.
At 150 mg/kg body weight/day, there was a slight reduction in food consumption during the dosing period. At this dose level no effects on the maternal reproduction parameters or on the fetal parameters were noted.
External and visceral examination of the fetuses, did not reveal any treatment related effects up to and including the dose level of 450 mg/kg body weight/day.
Based on these results, the no-observed adverse effect level for the maternal organism was considered to be 50 mg/kg body weight/day and for the fetal organism 150 mg/kg body weight/day. Under the conditions described in this study, test substance did not reveal any teratogenic potential up to and including the highest dose level of 450 mg/kg body weight/day.
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across hypothesis proposed is that the organism is not exposed to common compounds but rather, as a result of structural similarity, that different compounds have similar toxicological and fate properties. In this case the ECHA Read-Across Assessment Framework (RAAF) Scenario 2 is used.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source: N,N-Dimethyldecan-1-amide, mixture with N,N-Dimethyloctanc-1-amide [CAS 67359-57-3]
Target: Reaction Mass of N,N-Dimethyldodecanamide and N,N-Dimethyltetradecanamide [EC not assigned; CAS not assigned]
3. ANALOGUE APPROACH JUSTIFICATION
It may be concluded that both the registered substance (target) and the source molecules can be regarded as close structural analogues having both similar physical chemical and toxicological properties. It follows that where endpoints for the registered substance may not have experimental evidence, particularly those involving animal studies, that these can be addressed by read across grouping using an analogue approach. It is therefore proposed that, after careful assessment, experimental data from the source molecules may be used as surrogate evidence for read across to the registered substance. Please refer to attached document for information on the data available to support the read-across.
4. DATA MATRIX
Please refer to attached document - Reason / purpose for cross-reference:
- read-across source
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 50 - < 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: at 150 mg/kg bw/day slight reduction in food consumption
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 150 - < 450 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 450 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Referenceopen allclose all
At skeletal examination of the fetuses, the slightly increased incidence of fetuses with abnormal findings and the retardation in skeletal development noted for the fetuses at 450 mg/kg correlated with the reduced mean fetal body weight noted in this group. The abnormal skeletal findings in the 450 mg/kg group were not considered to be a specific teratogenic effect of the test article.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 450 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Studies used in this section were conducted with a mixture of a mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide (with traces of N,N-dimethyl-dodecanamide and N,N-dimethyl-hexanamide). It is assumed that due to the fact that a high amount in the mixture was N,N-dimethyl-decanamide and the rest of the mixture are homologues with a lower and higher molecular weight, the mixture has the identical toxicological behaviour than pure N,N-dimethyldecanamide.
Valid experimental data are available to assess the teratogenicity in rats with a mixture of N,N-dimethylamides.
In a study according to OECD 414 (RCC 1991, H. Becker) the mixture was administered orally by gavage, once daily, to mated female Wistar rats at dosages of 50, 150 or 450 mg/kg body weight/day from day 6 through to day 15 post coitum in order to assess the effects on embryonic and fetal development. In the dams at 450 mg/kg body weight/day, severe clinical signs of reaction to treatment, reduced food consumption and reduced body weight gain were observed. Additionally, at this dose level slightly increased post-implantation loss, reduced mean fetal body weights, an increased incidence of fetuses with common abnormal skeletal findings and retardations in skeletal development were noted. At 150 mg/kg body weight/day, there was a slight reduction in food consumption during the dosing period. At this dose level no effects on the maternal reproduction parameters or on the fetal parameters were noted. External and visceral examination of the fetuses, did not reveal any treatment related effects up to and including the dose level of 450 mg/kg body weight/day. Based on these results the author concluded that, the no-observed adverse effect level (NOAEL) for the maternal organism was considered to be 50 mg/kg body weight/day and for the fetal organism 150 mg/kg body weight/day and that under the conditions described in this study,the test substancedid not reveal any teratogenic potential up to and including the highest dose level of 450 mg/kg body weight/day.
Assessment of teratogenicity:
The study shows toxic effect to maternal and fetal organism, whereas the maternal organism reacts earlier and the fetus is only affected in higher dosages but the study did not show any teratogenic effect up to and including the highest dosage tested. The NOAELs derived were only based on weight reduction/slight reduced food comsumption by the author and considered by the applicant as not suitable for risk assessment, even as there are better studies available.
Key study assignment:
As there is only one reliable and relevant study available, this study is used as key study.
Justification for classification or non-classification
Due to citeria of legislation GHS (Regulation (EU) 1272/2008) for reproductive toxicans ("Suspected human reproductive toxicant Substances are classified in Category 2 for reproductive toxicity when there is some evidence from humans or experimental animals, possibly supplemented with other information......") the substance is not be classified as reproductive toxican as there is no evidence from the current available data. Also according to DSD (67/548/EEC) the available test results led not to a classification as reproductiv toxican.
Labelling for toxicity to reproduction:
GHS: no classification
DSD: no classification
Additional information
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.
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