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EC number: 400-390-6 | CAS number: 87787-67-5 FLEXSORB-SE
- 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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dosing inititated: January 24 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 410 (Repeated Dose Dermal Toxicity: 21/28-Day Study)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 7,7-dimethyl-3-oxa-6-azaoctan-1-ol
- EC Number:
- 400-390-6
- EC Name:
- 7,7-dimethyl-3-oxa-6-azaoctan-1-ol
- Cas Number:
- 87787-67-5
- Molecular formula:
- Hill formula: C8 H19 N O2 CAS formula: C8 H19 N O2
- IUPAC Name:
- 2-[2-(tert-butylamino)ethoxy]ethan-1-ol
- Details on test material:
- Material identification: MRD-82-178
Description: Amber liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dutchland Laboratories, Incorporated, Denver, PA
- Age at study initiation: Approx 16 weeks
- Weight at study initiation: 2.98 - 4.06 kg
- Housing: Individual stainless steel cage
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow (pellets), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 Days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 65 to 71 degrees Fahrenheit
- Humidity (%): 40 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: 10 x 20 cm
- Type of wrap if used: surgical tape and guaze.
- Time intervals for shavings or clipplings: Twice per week.
TEST MATERIAL
Test dilutions were prepared weekly by diluting the appropriate amounts of substance with distilled water. The volume of dosing solution applied to each animal was 2 ml/kg.
USE OF RESTRAINERS FOR PREVENTING INGESTION: Elizabethan-type collars. - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 5 days per week for at least 4 weeks. Male rabbits received a total of 21 applications and females 22 applications.
- Frequency of treatment:
- The test material was applied directly to the gauze 5 days per week.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0% (w/v)
Basis:
other: control group
- Remarks:
- Doses / Concentrations:
1.0% (w/v)
Basis:
analytical per unit area
- Remarks:
- Doses / Concentrations:
5.0% (w/v)
Basis:
analytical per unit area
- No. of animals per sex per dose:
- 10 males and 10 females per group.
Dose group I = 0%
Dose group II = 1.0%
Dose group III = 5.0% - Control animals:
- yes, concurrent vehicle
- Details on study design:
- Doses determined by preliminary study.
Animals determined to be unsutiable for inclusion on this study because of poor health, outlying body weights or other abnormalities were excluded from selection. - Positive control:
- No.
Examinations
- Observations and examinations performed and frequency:
- Each animal was observed daily during the 4 week dosing period for dermal and systemic toxicological responses. Clinical laboratory studies were conducted on blood samples collected pretest and at termination.
- Sacrifice and pathology:
- Gross necropsies were performed and specific organs retained.
- Statistics:
- The following parameters were statistically analyzed for significant differences.
- mean terminal hematology parameters.
- mean terminal clinical chemistry parameters.
- mean organ weights.
- mean organ to body weight ratio's.
- mean body weights, by weighing period.
- mean food consumption.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- not examined
- Haematological findings:
- effects observed, treatment-related
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Dermal irritation: The incidence and severity of dermal irritation increased with dose. Mild dermal irritation was observed in many of the low dose group animals. Irritation was more severe in the high dose groups.
Supplemental dermal observations of desquamation, necrosis and eschar were noted in several animals of the high dose group.
In-life observations: Four animals died prior to termination of the study. One Group I male was sacrificed for humane reasons on Day 21, and 1 female of group I was found dead on Day 29. 2 Group III males were found dead on Day 5 and on Day 28 respectively.
Food consumption: There were no treatment related effects on food consumption patterns.
Body weights: Mean body weights for all groups increased over the course of the study.
Hematology parameters: There were statistically significant differences from control in the Group III male MCH, Group II female platelet and Group II female MCHC values. It is unlikely that these differences are biologically significant.
Clinical Chemistry parameters: There were statistically significant differences from control noted in Group II male and female total blirubin, Group III female alkaline phosphatase, Group III male chloride and Group III female calcium values. The decreased calcium mean is attritutable to 1 abnormally low female value; the other mean values fall within the normal biological range for these parameters.
Necropsy Observations: The most common findings observed during gross postmortem examination were renel and pulmonary discolourations. The incidence of these findings was similar in all 3 groups and not considered treatment related.
Organ weights: A statistically elevation in mean adrenal gland weight and mean adrenal to body weight ratio was noted in Group II and III males.
Effect levels
- Dose descriptor:
- dose level: 5.0% w/v
- Effect level:
- 1 - 5 other: % w/v dose of substance causing dermal irritation.
- Sex:
- male/female
- Basis for effect level:
- other: By study termination, 5.0% test substance had elicited moderate to severe irritation in the females but only mild irritation in the majority of males.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- With the exception of primary dermal irritation, topical adminstration of the test substance at 2 concentrations to male and female rabbits for a period of approximately 4 weeks did not appear to produce toxicological change in the parameters and organs examined, which could unequivocally be related to treatment.
- Executive summary:
The objective of this study was to evaluate the dermal irritation potential and systemic toxicity of 2 concentrations of test material MRD-82 -178 following repeated topical application. The material was applied to the dorsal surface of rabbits 5 days per week for at least 4 weeks. 60 New Zealand White rabbits were divided into 3 groups of 10 males and 10 females each. Group I was used as a control. Groups II and III received 2 ml/kg administrations of 1.0 and 5.0% (w/v) test substance. Each animal was observed daily for dermal and systemic toxicological responses. Clinical laboratory studies were conducted on blood samples collected pre-test and at termination. Gross necropsies were performed and specific organs retained.
Four animals died prior to study termination: 1 male and 1 female in the control group and 2 males in the high dose group.
The incidence and severity of dermal irritation increased with dose. By study termination, 5.0% test substance had elicited moderate to severe irritation in the females but only mild irritation in the majority of males.
There was an overall low incidence of in-life observations noted in all 3 groups, with none appearing to be treatment related. There were no treatment related effects on food consumption patterns. Mean body weights for all groups increased over the course of the study.
Statistically significant differences were noted in a small number of mean terminal hematology and clinical chemistry values. It is unlikely that any of these differences are biologically significant.
A review of the in-life, clinical laboratory and gross necropsy findings did not reveal any significant signs of toxicity, other than primary irritation, which could be directly attributed to the administration of MRD-82 -178.
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