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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Dosing initiated: August 26 1986, Study termination (in vivo phase): September 26, 1986
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- similar to that described by B. Magnusson and A. Kligman in: "The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test"
- Deviations:
- no
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The first Test Guideline (TG) for the determination of skin sensitisation in the mouse, the Local Lymph Node Assay (LLNA; TG 429) was adopted in 2002. The OECD 406 study summarised for this skin sensitisation in vivo endpoint pre-dates the OECD 429 (the study report was produced in 1987).
Furthermore, in ECHA document Chapter R7a: Endpoint specific guidance (v6.0; July 2017); Section 7.2.3:
It is observed that for existing animal data, the use of methods other than those specified in the Annex to the EU Test Methods Regulation, or corresponding OECD methods may be accepted on a case-by-case basis - specifically including skin sensitisation test EU B.6/OECD TG 406 (as is the scenario with this substance).
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:
- - Name of test material (as cited in study report):
MRD-85-707
- Physical state:
Container 1 (used for rangefinder): Very pale yellow liquid
Container 2 (used for main study): Clear colourless water-like liquid
- Lot/batch No.:
1
- Stability under test conditions:
Analysis for stability, uniformity and concentration of all mixtures is the responsibility of the Sponsor.
- Storage condition of test material:
Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:
Charles River Breeding Laboratories, Kingston Facility, Stone Ridge, New York
- Age at study initiation:
Approximately 5 weeks
- Weight at study initiation:
306 - 376 grams
- Housing:
Individual, in suspended stainless steel.
- Diet (e.g. ad libitum):
Purina Certified Guinea Pig Chow ad libitum.
- Water (e.g. ad libitum):
Automatic watering system ad libitum
- Acclimation period:
14 Days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Monitored twice daily; maintained range of 65 to 71 degrees Fahrenheit.
- Humidity (%):
Monitored once daily; maintained range of 40 to 70% relative humidity.
- Photoperiod (hrs dark / hrs light):
Approximately 12 hours light and 12 hours dark by automatic timer.
IN-LIFE DATES: From: August 26th 1986 (Day 0) To: termination September 26th 1986
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Primol 185 (white oil)
- Concentration / amount:
- Day 0:
Site 1: 0.1 ml (FCA/water)
Site 2: 0.1 ml (1.0% MRD-85-707 in vehicle)
Site 3: 0.1 ml (1.0% MRD-85-707 in vehicle)
Day 7: 0.5 ml (25% MRD-85-707 in vehicle)
Day 21: 0.5ml (1.0% MRD-85-707 in vehicle)
Day 28: 0.5 ml (1.0% MRD-85-707 in vehicle)
Challengeopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: Primol 185 (white oil)
- Concentration / amount:
- Day 0:
Site 1: 0.1 ml (FCA/water)
Site 2: 0.1 ml (1.0% MRD-85-707 in vehicle)
Site 3: 0.1 ml (1.0% MRD-85-707 in vehicle)
Day 7: 0.5 ml (25% MRD-85-707 in vehicle)
Day 21: 0.5ml (1.0% MRD-85-707 in vehicle)
Day 28: 0.5 ml (1.0% MRD-85-707 in vehicle)
- No. of animals per dose:
- Total of 30 animals, 15 in treatment group, 15 as a control group.
- Details on study design:
- RANGE FINDING TESTS:
Not recorded
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:
3
- Exposure period:
21 Days
- Test groups:
1 Treatment group of 15 animals.
- Control group:
1 control group of 15 animals.
- Site:
An area measuring approximately 4 x 6 cm, near the scapula in the mid-dorsal region of all animals was clipped on the day prior to intradermal injection of the test material and/or vehicle. All animals were clipped using Oster A-2 Small Animal Clippers equipped with size 40 blades.
Solutions for Site 1 and Site 2 were injected close together and near the first thoracic vertebra; the solution for Site 3 was injected more caudally.
- Frequency of applications:
every 7 days until day 28
- Duration:
21 Days
- Concentrations:
Day 0:
Site 1: 0.1 ml (FCA/water)
Site 2: 0.1 ml (1.0% MRD-85-707 in vehicle)
Site 3: 0.1 ml (1.0% MRD-85-707 in vehicle)
Day 7:
0.5 ml (25% MRD-85-707 in vehicle)
B. CHALLENGE EXPOSURE
- No. of exposures:
2
- Day(s) of challenge:
Day 21 and Day 28
- Exposure period:
24 hours
- Test groups:
1 Treatment group of 15 animals.
- Control group:
1 Treatment group of 15 animals.
- Site: The fur in an area measuring approximately 5 x 5 cm on the right flank in the abdominal region was clipped approximately 4 hours prior to challenge dosing of the test material.
For rechallenge, the same area on the left flank was clipped prior to dosing.
- Concentrations:
Day 21: 0.5ml (1.0% MRD-85-707 in vehicle)
Day 28: 0.5 ml (1.0% MRD-85-707 in vehicle)
- Evaluation (hr after challenge):
Evaluation of sensitisation potential was based on a comparison of treated and irritation control group dermal responses. Since sensitisation to any material requires multiple exposures, control group responses were used to distinguish true sensitisation from local irritation produced by a single exposure to the same concentration of test material.
OTHER: - Challenge controls:
- Irritation control group - 1.0% MRD-85-707 in vehicle at 21 days, No treatment at 28 days.
- Positive control substance(s):
- yes
- Remarks:
- Formalin
Results and discussion
- Positive control results:
- Please see Appendix C attached for details on results.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 10
- Total no. in group:
- 15
- Clinical observations:
- Exhibited slight to well-defined etythema. No edema was noted following rechallenge.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1.0%. No with. + reactions: 10.0. Total no. in groups: 15.0. Clinical observations: Exhibited slight to well-defined etythema. No edema was noted following rechallenge..
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 12
- Total no. in group:
- 15
- Clinical observations:
- Exhibited slight to well-defined etythema. No edema was noted following rechallenge.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 1.0%. No with. + reactions: 12.0. Total no. in groups: 15.0. Clinical observations: Exhibited slight to well-defined etythema. No edema was noted following rechallenge..
- Reading:
- rechallenge
- Hours after challenge:
- 216
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 10
- Total no. in group:
- 13
- Clinical observations:
- Exhibited slight to well-defined erythema. No edema was noted following rechallenge. 2 animals found dead at Day 30.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 216.0. Group: test group. Dose level: 1.0%. No with. + reactions: 10.0. Total no. in groups: 13.0. Clinical observations: Exhibited slight to well-defined etythema. No edema was noted following rechallenge. 2 animals found dead at Day 30..
- Reading:
- rechallenge
- Hours after challenge:
- 240
- Group:
- test chemical
- Dose level:
- 1.0%
- No. with + reactions:
- 8
- Total no. in group:
- 13
- Clinical observations:
- Exhibited slight to well-defined etythema. No edema was noted following rechallenge. 2 animals found dead at Day 30.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 240.0. Group: test group. Dose level: 1.0%. No with. + reactions: 8.0. Total no. in groups: 13.0. Clinical observations: Exhibited slight to well-defined etythema. No edema was noted following rechallenge. 2 animals found dead at Day 30..
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 9
- Total no. in group:
- 15
- Clinical observations:
- Exhibited slight to well-defined etythema. No edema was noted following rechallenge. 1 animal found day on Day 23.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 9.0. Total no. in groups: 15.0. Clinical observations: Exhibited slight to well-defined etythema. No edema was noted following rechallenge. 1 animal found day on Day 23..
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Untreated
- No. with + reactions:
- 8
- Total no. in group:
- 15
- Clinical observations:
- Exhibited slight to well-defined etythema. No edema was noted following rechallenge. 1 animal found day on Day 23.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 72.0. Group: negative control. Dose level: Untreated. No with. + reactions: 8.0. Total no. in groups: 15.0. Clinical observations: Exhibited slight to well-defined etythema. No edema was noted following rechallenge. 1 animal found day on Day 23..
- Reading:
- rechallenge
- Hours after challenge:
- 552
- Group:
- positive control
- Dose level:
- 0.1 mL
- No. with + reactions:
- 15
- Total no. in group:
- 15
Any other information on results incl. tables
- Irritation Control:
One irritation control animal died prior to study termination. Of the surviving animals one animal displayed a weight loss when compared to their initial values. All remaining animals displayed an increase in body weight over the initial values.
Following topical challenge with 1.0% MRD-85-707, very slight to well-defined erythema was noted for nine irritation control animals on Day 23 and for each animals on Day 24.
Gross postmortem examination of the animal which succumbed prior to study termination revealed:
JDE929F
A/G Area: Slight amount of brown material on fur
Stomach: Empty, slight amount of mucous like material
Cecum: One half normal size, slight amount of green-brown thickened material
Small Intestine: Slight amount of frothy amber material
Gall Bladder: Slight amount of green, grainy material in the clear amber liquid
Individual challenge dermal irritation scored for all animals are presented in Table 1 (attached). The incidence of challenge dermal irritation scores for each group is presented in Table 2 (attached) The incidence of in-life observations is presented in Table 3 (attached). Individual animal body weights by weighing period and dose, including the means and standard deviations, are presented in Table 4.
Gross postmortem examination of the animals which succumbed prior to study termination revealed:
Test treatment group
JDE934F
A/G Area: Slight amount of brown staining on fur
Gall Bladder: Small approximately 0.6 cm diameter
Cecum: Filled with liquid-like ingesta
JDF031F
A/G Area: Moderate amount of brown staining on fur
Stomach: Slight amount of dark brown tar-like material. Moderate number of dark brown-black foci over the surface of the inner mucosa
Cecem: Empty, one third normal size
Validation:
Environmental Deviation:
On September 26th 1986 normal power was out for a total of 3 hours, 40 minutes due to a Public Service Electric power failure. Emergency power was on for a total of 4 hours, 10 minutes. The animal room temperature and humidity were checked and were within the required tolerance during this period.
Protocol Deviation:
On Day 7, a 25% (w/v) mixture was administered to the treated group animals instead of a 75% (w/v) mixture. The deviation was caused by a calculation and verification error on the test material preparation sheet. The effect of this deviation is undetermined since the 25% mixture was a slightly irritating concentration.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Following topical challenge with 1.0% MRD-85 -707, the incidence and severity of dermal irritation was similar for both the treated and control groups. Following rechallenge, the treated animals displayed a slightly lower severity and incidence of dermal irritation.
Based on these findings, it appears that MRD-85 -707 should be classified as a non-sensitiser. - Executive summary:
The allergic contact sensitisation potential of MRD-85 -707 was evaluated in 15 female Hartley albino guinea pigs following intradermal injection and 3 topical occlusive exposures. An irritation control group of 15 female guinea pigs received only a single topical exposure to the test material. The technique employed was similar to that described by B. Magnusson and A. Kligman in: "The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximisation Test", Journal of Investigate Dermatology, Vol. 52: 268 -276, 1969. Evaluation of sensitisation potential was based on a comparison of treated and control group dermal scores. A known sensitiser (positive control) was tested concurrently for purposes of comparison.
Dermal responses were evaluated approximately 24 hours after each of the induction exposures, and 24 and 48 hours after the removal of the challenge patch, and 24 and 48 hours after removal of the re-challenge patch for treated group animals only, according to the Draize Method of scoring. Observations were made as to the nature, on-set, severity and duration of toxicological signs immediately after dosing on Day 0 and on Days 7, 14, 21 and prior to terminal sacrifice. Observations were also made on Day 28 for treated group animals only. Body weights were recorded at initiation of dosing and on Day 7, 14, 21 and at sacrifice. Body weights were also recorded on Day 28 for animals of the treated group. After the final clinical in-life observations and weighings, all animals were sacrificed by carbon dioxide asphyxiation and discarded without further examination. Animals dying prior to study termination were subjected to a gross postmortem examination.
One irritation control and two treated group animals died prior to study termination. These animals exhibited gastro-intestinal tract abnormalities on gross postmortem examination.
One animal in each group displayed a weight loss when compared to the initial values. The remaining animals displayed an increase in body weight over the initial values.
Clinical in-life observations noted during the study were minimal with the majority of the animals exhibiting no observable abnormalities.
Treated group animals received 1.0% and 25.0% MRD-85 -707 during the intradermal and topical induction phases respectively. Following topical challenge with 1.0% MRD-85 -707, the incidence and severity of dermal irritation was similar for both the treated and control groups. Following rechallenge, the treated animals displayed a slightly lower severity and incidence of dermal irritation.
Based on these findings, it appears that MRD-85 -707 should be classified as a non-sensitiser.
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