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EC number: 471-920-1 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005-10-25 to 2006-03-16; Amended 2007-08-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Qualifier:
- according to guideline
- Guideline:
- other: US OPPTS 870.3050 Repeated Dose 28-Day Oral Toxicity Study in Rats
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Chemical Substance Control Law Guidelines of 21 November 2003 (28-day repeat oral dose study).
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Details on test material:
- - Chemical name: Reaction product of poly (n=1-3) cocamine (C8, C10, C12, C14, C16, C17, and C18, linear and branched) with glycolic acid including N,N_Didodecyl-2-hydroxyacetamide as a main component.
- Physical state: dark amber slightly viscous liquid
- Analytical purity: 100%
- Storage condition of test material: room temperature in the dark
- Stability during study: Stability of test concentrations performed during study. Formulations stable for at least 14 days. Prepared weekly and stored at +4°C in the dark.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Limited, Margate, Kent UK
- Age at study initiation: 6 to 8 weeks
- Weight at study initiation: males: 145 to 185 g and females: 128 to 158 g
- Fasting period before study: No
- Housing: groups of five by sex in polyproylene grid-floor cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hour dark and light cycle
IN-LIFE DATES: From: 2005-10-05 To: 2006-01-03
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
VEHICLE
- Justification for use and choice of vehicle (if other than water): stability and solubility
- Concentration in vehicle: 6.25, 62.5, 250 mg/mL
- Amount of vehicle (if gavage): 4 mL/kg - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC using an external standard.
Samples and standards extracted in acetone to give a concentration of 0.05 mg/mL
GC system: Agilent Technologies 5890
Column: DB-1 (30 x 0.32 mm id x 0.25µm film)
Oven temperature: Initial 200°C for 0 mins, rate 10°C/min, final 325°C for 15 mins
Injection temp: 250°C
Flame ionisation detector temp: 300°C
Injection volume: 1 µL
Specificity: No interference
Accuracy: 86 - 118%
Stability determination: analysed initally and after 14 days in the dark at +4°C.
Stability: 92 - 105% of initial concentration after 14 days
Formulation concentrations:
Formulation: 86 - 104% of nominal - Duration of treatment / exposure:
- 28-days
- Frequency of treatment:
- once daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
25 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
250 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- five male/five female
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: range-finder
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: Not stated
- Post-exposure recovery period in satellite groups: 14 days
- Section schedule rationale (if not random): random - Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule: Prior to start of treatment and on Days 7, 12, 16 ansd 23
- Battery of functions tested: sensory activity / grip strength / motor activity
- Cage side observations: behavioural assessments, funtional performance tests, sensory reactivity .
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: immediately before dosing, immediately post dosing and one and five hours after dosing during the working week. Animals were observed immediately before dosing and one hour after dosing at weekends. During the treatment-free period, animals were observed twice daily, morning and afternoon (once daily at weekends).
BODY WEIGHT: Yes
- Time schedule for examinations: Day 1 (prior to the start of treatment) and on Days 8, 15,22 and 29 prior to terminal kill, and, in the case of recovery group animals, on Days 36 and 43 prior to terminal kill.
FOOD CONSUMPTION:
- Food consumption: recorded for each cage group at weekly intervals throughout the study.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION :
- Time schedule for examinations: daily, for each cage group, by visual inspection of the water bottles for any overt changes.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of the treatment period (Day 28) and on all surviving recovery group animals at the end of the treatment-free period (Day 42). Where necessary repeat samples were obtained by cardiac puncture prior to necropsy on Days 29 and 43
- Anaesthetic used for blood collection: No
- Animals fasted: No
- How many animals: All animals
- Parameters examined:
EDTA anti-coagulant:
Haemoglobin (Hb)
Erythrocyte count (RBC)
Haematocrit (Hct)
Erythrocyte indices - mean corpuscular haemoglobin (MCH)
- mean corpuscular volume (MCV)
- mean corpuscular haemoglobin concentration (MCHC)
Total leucocyte count (WBC)
Differential leucocyte count
- neutrophils (Neut)
- lymphocytes (Lymph)
- monocytes (Mono)
- eosinophils (Eos)
- basophils (Bas)
Platelet count (PLT)
Reticulocyte count (Retic)
- Cresyl blue stained slides were prepared but reticulocytes were not assessed
Prothrombin time (CT) was assessed by ‘Thrombomax HS with calcium’ and Activated partial thromboplastin time (APTT) was assessed by ‘Actin FS’ using samples collected into sodium citrate solution (0.1 1 moV1)
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of the treatment period (Day 28) and on all surviving recovery group animals at the end of the treatment-free period (Day 42). Where necessary repeat samples were obtained by cardiac puncture prior to necropsy on Days 29 and 43
- Animals fasted: No
- How many animals: All
- Parameters examined:
Urea
Glucose
Total protein (Tot.Prot.)
Albumin
AlbumidGlobulin (A/G) ratio (by calculation)
Sodium (Na+)
Potassium (K+)
Chloride (Cl-)
Calcium (Ca++)
Inorganic phosphorus (P)
Gamma glutamyltranspeptidase (yGT)
Aspartate aminotransferase (ASAT)
Alanine aminotransferase (ALAT)
Alkaline phosphatase (AP)
Creatinine (Creat)
Triglycerides (Tri)
Total cholesterol (Chol)
Total bilirubin (Bili)
URINALYSIS: Yes
- Time schedule for collection of urine: non-recovery test and control group animals during Week 4 and on all surviving recovery group animals during Week 6.
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters examined:
Volume
Specific Gravity
Protein
Glucose
PH
Ketones
Bilirubin
Urobilinogen
Reducing Substances
Blood
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Organ weights:
Adrenals
Brain
Epididymides
Heart
Kidneys
Liver
Ovaries
Spleen
Testes
Thymus
HISTOPATHOLOGY: Yes
Aorta (thoracic)
Bone & bone marrow (femur including stifle joint)
Bone & bone marrow (sternum)
Brain (including cerebrum, cerebellum and pons)
Caecum
Colon
Duodenum
Epididymides
Eyes
Gross lesions
Heart
Ileum
Jejunum
Kidneys
Liver
Lungs (with bronchi)#
Oesophagus
Ovaries
Pancreas
Pituitary
Prostate
Rectum
Salivary glands (submaxillary)
Sciatic nerve
Seminal vesicles
Skin (hind limb)
Spinal cord (cervical)
Spleen
Stomach
Testes
Thymus
Thyroiflparathyroid
Trachea
Lymph nodes (cervical and mesenteric)
Muscle (skeletal) Uterus
Urinary bladder - Other examinations:
- None
- Statistics:
- Data were processed to give group mean values and standard deviations where appropriate.
All data were summarised in tabular form. Where appropriate, quantitative data were analysed by the ProvantisTM Tables and Statistics Module. For each variable, the most suitable transformation of the data was found, the use of possible covariates checked and the homogeneity of means assessed using ANOVA or ANCOVA and Bartlett's test. The transformed data were analysed to find the lowest treatment level that showed a significant effect, using the Williams Test for
parametric data or the Shirley Test for non-parametric data. If no dose response was found, but the data showed non-homogeneity of means, the data were analysed by a stepwise Dunnett (parametric) or Steel (non-parametric) test to determine significant differences from the control group. Finally, if required, pair-wise tests were performed using the Student t-test (parametric) or the Mann-Whitney U test (non-parametric).
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- Mortality. One control male was killed on humane grounds due to the severity of its clinical observations on Day 26. There were no other unscheduled deaths during the study.
- Mortality:
- no mortality observed
- Description (incidence):
- Mortality. One control male was killed on humane grounds due to the severity of its clinical observations on Day 26. There were no other unscheduled deaths during the study.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
Effect levels
- Dose descriptor:
- NOAEL
- Remarks:
- No Observed Effect Level (NOEL)
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The oral administration of the test material to rats for a period of twenty-eight consecutive days at dose levels of 1000 mg/kg/day did not result in any toxicologically significant changes. The ‘No Observed Effect Level’ (NOEL) was considered to be 1000 mg/kg/day.
- Executive summary:
Test Guidance
i) Commission Directive 96/54/EC (Method B7).
ii) The Japanese Ministry of Economy Trade and Industry (METI), Ministry of Health, Labour and Welfare (MHLW) and Ministry of the Environment (MOE) Guidelines of 21 November 2003 for a twenty-eight day repeat dose oral toxicity study as required by the Law Concerning the Evaluation of Chemical Substances and Regulation of their Manufacture, etc (Chemical Substance Control Law) 1973 of Ministry of International Trade and Industry (MITI) amended 2004.
iii) The OECD Guidelines for Testing of Chemicals No. 407 "Repeated Dose 28 Day Oral Toxicity Study in Rodents" (adopted 27 July 1995).
iv) USA Environmental Protection Agency (EPA) Health Effects Test Guidelines, OPPTS 870.3050 Repeated Dose 28-Day Oral Toxicity Study in Rodents, July 2000.
Method and materials.
The test material was administered by gavage to three groups, each of five male and five female Sprague-Dawley Crl:CD@ (SD) IGS BR strain rats, for up to twenty-eight consecutive days, at dose levels of 25, 250 and 1000 mg/kg/day. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP). Two recovery groups, each of five males and five females, were treated with the high dose (1000 mg/kg/day) or the vehicle alone for up to twenty-eight consecutive days and then maintained without treatment for a further fourteen days.
Clinical signs, bodyweight development and food and water consumption were monitored during the study. Haematology, blood chemistry and urinalysis were evaluated for all non-recovery group animals at the end of the treatment period and for all surviving recovery group animals at the end of the treatment-free period.
All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from non-recovery high dose and control animals was performed.
Results.
Mortality. One control male was killed on humane grounds due to the severity of its clinical observations on Day 26. There were no other unscheduled deaths during the study.
Clinical Observations. No clinically observable signs of toxicity were detected throughout the study period.
Behavioural AssessmentWeekly behavioural assessments revealed no treatment-related changes in the parameters measured.
Functional Performance Tests. There were no treatment-related changes in the functional performance parameters measured.
Sensory Reactivity Assessments. There were no treatment-related changes in sensory reactivity.
BodyweightNo adverse effect on bodyweight or bodyweight gains were detected.
Food Consumption. No adverse effect on dietary intake or food efficiency was detected.
Water Consumption. Daily visual inspection of water bottles revealed no intergroup differences.
Haematology.There were no toxicologically significant changes in the haematological parameters investigated.
Blood Chemistry.There were no toxicologically significant effects on the blood chemistry parameters investigated.
Urinalysis. No treatment-related urinalytical effects were detected.
Organ Weights. No toxicologically significant treatment-related organ weight changes were detected.
Necropsy. No treatment-related macroscopic abnormalities were detected.
Histopathology. No treatment-related changes were detected.
Conclusion.
Oral administration of the test material to rats for a period of twenty-eight consecutive days at dose levels of 1000 mg/kg/day did not result in any toxicologically significant changes. The ‘No Observed Effect Level’ (NOEL) was considered to be 1000 mg/kg/day.
In accordance with EU CLP Regulation (EC) No. 1272/2008, classification of this substance is not required for subacute repeat oral dose toxicity
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.
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