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EC number: 267-382-0 | CAS number: 67846-68-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 1986-02-04 to 1986-03-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Concentration used for induction was not the highest to cause mild irritation as postulated by the OECD guideline 406.
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- MDEA-Esterquat C16-18 and C18 unsatd.
- IUPAC Name:
- MDEA-Esterquat C16-18 and C18 unsatd.
- Details on test material:
- - Name of test material (as cited in study report): Fv-base E2819.01
- Diethylester dimethyl ammonium chloride
- Molecular formula (if other than submission substance): C42H84NO4.Cl
- Molecular weight (if other than submission substance): 702.582
- Substance type: Pure active substance
- Physical state: solid
- Analytical purity: confidential detail
- Impurities (identity and concentrations): none
- Composition of test material, percentage of components: confidential detail
- Isomers composition: NA
- Purity test date: confidential detail
- Lot/batch No.: confidential detail
- Expiration date of the lot/batch: confidential detail
- Radiochemical purity (if radiolabelling): Not applicable
- Stability under test conditions: Not given
- Storage condition of test material: Room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Lippische Versuchstierzucht Hagemann GmbH & Co.
- Age at study initiation: Not available
- Weight at study initiation: 340 grams (estimated)
- Housing: 5 animals in macrolon plastic cages IV (20 cm high, 33 cm width, 55 cm length)
- Diet (e.g. ad libitum): ad libitum Ssniff -G
- Water (e.g. ad libitum):ad libitum,Aqua fontana as for human consumption
- Acclimation period: at least 4 days instead of 5 days recommended by the OECD guideline 406
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2 °C
- Humidity (%): 50-85 instead of 30 - 70 % recommended by the OECD guideline 406.
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12 hours daily,light-dark cycle
IN-LIFE DATES: From: 1986-01-13 To: 1986-03-29
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: For induction- 96% ethanol wa used instead of 80 % recommended by the OECD guideline 406 , Challenge/ rechallenge-acetone
- Concentration / amount:
- Induction 15 %
Challenge 15 %
Rechallenge 15 % and 7.5 %
One group of 20 test animals were treated with 0.3 ml of 15 % test substance in ethanol while a group of 10 control animals were treated with 0.3 ml of ethanol in Hill Top Chambers for a period of 6 hours weekly for 3 induction exposures. Both control and test animals were challenged with 15 % test substance in acetone. The test and control animals were rechallenged with 7.5 % and 15 % test substance in acetone.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: For induction- 96% ethanol wa used instead of 80 % recommended by the OECD guideline 406 , Challenge/ rechallenge-acetone
- Concentration / amount:
- Induction 15 %
Challenge 15 %
Rechallenge 15 % and 7.5 %
One group of 20 test animals were treated with 0.3 ml of 15 % test substance in ethanol while a group of 10 control animals were treated with 0.3 ml of ethanol in Hill Top Chambers for a period of 6 hours weekly for 3 induction exposures. Both control and test animals were challenged with 15 % test substance in acetone. The test and control animals were rechallenged with 7.5 % and 15 % test substance in acetone.
- No. of animals per dose:
- 20 animals in the test substance group and 10 animals in the vehicle control group
- Details on study design:
- RANGE FINDING TESTS:
INDUCTION: The entire back and both sides were clipped one day prior to application. Four animals were exposed for 6 hour period to various concentrations (0.3 ml of each/patch)of the test substance.
Concentrations -20 %, 10 %, 5 %, 2.5 % in ethanol 96 %
Grading: at 24hours and 48 hours
Challenge: a single dermal treatment was performed in 2 guinea pigs using 15% dilution of the test compound in acetone and responses were graded at 24 and 48 hours
MAIN STUDY
A. INDUCTION EXPOSURE
Prior to treatment the left shoulder of each animal was clipped with a small animal clipper. 0,3 ml of the freshly prepared test substance were applied to the Hill Top Chambers and placed on the clipped surface of each animal in the test group and secured with rubber dental dam. Animals were immobilized in metal restrainers for 6 hours. After that time patches were taken off and the test substance was removed with a gentle rinse of warm water before returning the animals to their cages. The procedure was repeated at the same site once a week for the next two weeks.
- No. of exposures: three
- Exposure period: once weekly for three weeks
- Test groups: 20 animals were exposed to 0.3 ml of 15 % in ethanol 96 %
- Control group: 10 animals, procedure not described
- Site: back and both sides of the animal
- Frequency of applications: once a week
- Duration: 6 hours
- Concentrations: 15 % test substance in ethanol 96 %
B. CHALLENGE EXPOSURE
The animals from the test group as well as from the control group were treated following the same patching procedure as described for induction.
- No. of exposures: one 6 hours exposure
- Day(s) of challenge: two weeks after the third induction exposure
- Exposure period: 6 hour under occlusion
- Test groups: 0.3 ml of 15% dilution in acetone
- Control group0.3 ml of 15% dilution in acetone
- Site: patches were applied to a naive skin site
- Concentrations: 15% test substance in acetone
- Evaluation (hr after challenge): 24 and 48 hours
OTHER:
RECHALLENGE:
It was done 18 days after challenge. Test animals and new untreated control animals were treated on naive skin analogously to induction and challenge and grading at 24, 44, 48 hours. Concentrations for rechallgenge 15 % and 7.5 % in acetone.
Grading of all animals was done by positioning them under a four tube fluorescent type light. The control animals were graded before the test animals according to the Scoring system below.
Scores:
No reaction 0
slight patchy erythema ± (0,5)
Slight, but confluent or moderate
Patchy erythema 1
Moderate erythema 2
Severe erythema with or without edema 3 - Challenge controls:
- Challenge controls was 15 % test substance in acetone. Rechallenge controls were 7.5 % and 15 % test substance in acetone
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15% in acetone
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- 1/20 animal (grade 1)
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1/20 animal (grade 1).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15% in acetone
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Clinical observations:
- 1/20 animal (grade 1)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 1.0. Total no. in groups: 20.0. Clinical observations: 1/20 animal (grade 1).
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15% acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 15% acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 7.5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 15% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 7.5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
- Reading:
- rechallenge
- Hours after challenge:
- 44
- Group:
- test chemical
- Dose level:
- 15% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 44.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 44
- Group:
- test chemical
- Dose level:
- 7.5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 44.0. Group: test group. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 44
- Group:
- negative control
- Dose level:
- 15% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 44.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 44
- Group:
- negative control
- Dose level:
- 7.5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 44.0. Group: negative control. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 15% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 15% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 7.5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no animals with positive response
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no animals with positive response .
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 7.5% in acetone
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no animals with positive responses
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 7.5% in acetone. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no animals with positive responses.
Any other information on results incl. tables
No skin alterations were observed during the induction period with 15 % test substance in ethanol 96%. At challenge, slight erythema was observed in 1/20 test animals. No skin reactions were observed in the control animals. Both test and control animals were rechallenged with 15 % and 7.5% test substance in acetone. No skin responses were observed at rechallenge. Normal weight gains were observed during the study.
It was concluded that the test substance is not a sensitizer.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: GHS Regulation EC No 1272/2008
- Conclusions:
- MDEA-Esterquat C16-18 and C18 unsatd. did not induce sensitization in the guinea pig model.
- Executive summary:
In a dermal sensitization study according to OECD guideline 406; 12 May, 1981 with MDEA-Esterquat C16-18 and C18 unsatd. (80 % a.i) in IPA, Pirbright - Hartley guinea pig (10 male and 10 female) were tested using the method of Bühler.
No skin alterations were observed during the induction period with 15 % test substance in ethanol 96%. At challenge, slight erythema was observed in 1/20 test animals. No skin reactions were observed in the control animals. Both test and control animals were rechallenged with 15 % and 7.5 % test substance in acetone. No skin responses were observed at rechallenge.
In this study, MDEA-Esterquat C16-18 and C18 unsatd. is not a dermal sensitizer.
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