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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Reaction mass of N,N-ethanediylbis- Hexadecanamide, N-[2-[(1-oxohexadecyl)amino]ethyl]-Octadecanamide, Hexadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine, N,N-ethanediylbis-Octadecanamide and Octadecanoic acid, 12-hydroxystearic acid, reaction products with ethylenediamine
EC number: 906-763-4 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Not mandatory since data on developmetal toxicity available
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
Effects on developmental toxicity
Description of key information
Developmental toxicity / teratogenicity (OECD 414):
NOAELmaternal ≥ 1000 mg/kg bw/d;
NOAELdevelopmental ≥ 1000 mg/kg bw/d
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)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy S.r.l., San Pietro al Natisone, Italy
- Age at study initiation: 9 weeks (female) and 11 weeks (male)
- Weight at study initiation: 191 - 221 g (female) and at least 316 g (male)
- Housing: Before and after pairing, the animals were housed no more than 5 of one sex to a cage, in clear polycarbonate cages measuring 59x38.5x20 cm with a stainless steel mesh lid and floor (Techniplast Gazzada S.a.r.l., Buguggiate, Varese). Each cage tray held absorbent paper which was inspected and changed at least 3 times per week. During the mating period, the rats were housed on the basis of 1 male to 1 female in clear polycarbonate cages measuring 43x27x18 cm with a stainless steel mesh lid and floor (Techniplast Gazzada S.a.r.l., Buguggiate, Varese). Each cage tray held absorbent material which was inspected and changed daily.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 15 - 25
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The required amount of test substance was suspended in the vehicle; the formulatiuons were prepaired daily and concentrations were calculated and expressed in terms of test item as supplied.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Solubility
- Concentration in vehicle: 10, 30 and 100 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- By chemical analysis (concentration, homogeneity and stability), all parameters in range limits
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1/1 in the home cage of the male
- Length of cohabitation: left overnight
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- All animals were dosed from Day 6 through Day 19 post coitum.
- Frequency of treatment:
- Once a day
- Duration of test:
- 20 days post coitum
- No. of animals per sex per dose:
- 24 mated females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: based on preliminary study
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Throughout the study, all animals were checked early in each working day and again in the afternoon. At weekends and Public Holidays a similar procedure was followed except that the final check was carried out at approximately mid-day.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: All clinical signs were recorded for individual animals from allocation to sacrifice.
Once daily before commencement of treatment and once daily at approximately 1-1.5 hours after treatment, each animal was observed and any clinical signs were recorded.
BODY WEIGHT: Yes
- Time schedule for examinations: All animals were weighed on Days 0, 3, 6, 9, 12, 15 and 20 post coitum.
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, On Days 3, 6, 9, 12, 15 and 20 post coitum starting from Day 0 post coitum.
POST-MORTEM EXAMINATIONS: Yes, The animals were killed with carbon dioxide on Day 20 post coitum and necropsied , all foetuses were sacrificed by hypothermia. Necropsy: The clinical history of the animal was studied and a detailed post mortem examination was conducted (including examination of the external surface and orifices) and changes were noted.
- Sacrifice on gestation day 20 - 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 - Fetal examinations:
- - External examinations: Yes: all per litter, Number, sex and weight of all live foetuses; Number and sex of dead foetuses (foetuses at term without spontaneous movements and breathing); Number of intra-uterine deaths classified as: Early resorptions: only placental remnants visible, Late resorptions: placental and foetal remnants visible.
- Soft tissue examinations: Yes: half per litter, fixed-visceral examination of all groups, gross evaluation of placentae.
- Skeletal examinations: Yes: half per litter, skeletal examinations were performed in all groups. Structural deviations were classified as follows: Malformations: major abnormalities that are rare and/or affect the survival or health of the species under investigation; Anomalies: minor abnormalities that are detected relatively frequently; Variants: a change that occurs within the normal population under investigation and is unlikely to adversely affect survival or health. This might include a delay in growth or morphogenesis that has otherwise followed a normal pattern of development.
- Head examinations: Yes, part of skeletal examination - Statistics:
- Continuous variables: Dunnett's test or a modified t test
Non-continuous variables: Kruskal-Wallis test
Intergroup differences between the control and treated groups: Non-parametric version of the Williams test - Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- no effects observed
- Dead fetuses:
- no effects observed
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Effects on pregnancy duration" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsMaternalAnimals.MaternalDevelopmentalToxicity.EffectsOnPregnancyDuration): no effects observed - Changes in number of pregnant:
- no effects observed
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
- No mortality occurred during the study.
- One female in the low dose group was found not pregnant at necropsy.
- Unilateral implantation was detected in one low dose female.
- The number of females with live foetuses on gestation Day 20 was 24 each in the control, mid- and high dose groups and 23 in the low dose group.
- No clinical sign was detected in any animal during the whole study and no sign of reaction to treatment was noted.
- In all treated females body weight and body weight gain were comparable to controls throughout the study.
- No changes were detected in food consumption between treated and control females.
- No significant differences were noted in terminal body weight, uterus weight and absolute weight gain within the groups.
- No findings were detected in treated females that could be considered treatment-related. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Key result
- Abnormalities:
- no effects observed
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): no effects observed - Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
- Litter data and sex ratio were not affected by treatment.
- Two small foetuses (weight less than 2.7 g) were found in the control group and one in each of the treated groups.
- No other abnormalities were detected at the external examination of all foetuses.
- Malformations were noted in three foetuses, one in the control group, one in the mid-dose group and one in the high dose group. These malformations and the other findings noted were considered to be incidental.
- No changes that could be considered treatment-related were noted at skeletal examination of the foetuses between control and treated groups. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse treatment-related effects observed
- Key result
- Abnormalities:
- no effects observed
- Key result
- Developmental effects observed:
- no
- Conclusions:
- On the basis of the results obtained in this study, the dosage of 1000 mg/kg bw/day is considered as the NOAEL.
Reference
Neither clinical signs nor signs of reaction to treatment were noted in treated females. No significant differences were noted in body weight, food consumption, gravid uterus weight, litter data and macroscopic observation of treated females when compared to controls. No treatment-related changes were seen at the external, visceral and skeletal examination of foetuses from all groups. On the basis of the results obtained in this study, the dosage of 1000 mg/kg bw/day is considered as the NOAEL.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- reliable without restriction
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is data available from a prenatal developmental toxicity study (Liberati, 2009) performed with the structural analogue, Licowax C, which was chosen as the key study, and the corresponding preliminary test which served as a range finder (Liberati, 2008).
In the key study doses of 100, 300 and 1000 mg/kg bw/day, which had been analytically confirmed, were administered by oral gavage. No maternal toxic effects were observed up to the highest dose of 1000 mg/kg bw/day, there were no mortality or clinical signs observed. Food consumption and body weight development were not affected by treatment with the test substance, either. The number of dams with live fetuses was comparable among all dose groups. Litter data and sex ratio were not affected by the treatment, and no visceral or skeletal abnormalities were noted within the foetuses which could be attributed to the test substance.
Justification for classification or non-classification
The available data on toxicity to reproduction of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for 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.