Registration Dossier
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EC number: 931-203-0 | 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

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:
- 2002-01-29 to 2002-03-08
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read-across from a guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- July 30, 1996
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- fully saturated TEA-Esterquat
- IUPAC Name:
- fully saturated TEA-Esterquat
- Reference substance name:
- Fatty acids, C16-18 even numbered, reaction products with triethanolamine, di-Me sulfate-quaternized
- IUPAC Name:
- Fatty acids, C16-18 even numbered, reaction products with triethanolamine, di-Me sulfate-quaternized
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Mol:DH (Moellegaard)
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 100 % in deionized water
Challenge: 100 % in deionized water
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 100 % in deionized water
Challenge: 100 % in deionized water
- No. of animals per dose:
- 3 ‐ preliminary study
10 – main study control
20 – main study treatment - Details on study design:
- PRELIMINARY STUDY AND DOSE RANGE FINDING
Left flank: 20 % (in deinonized water), 100% (moistened)
Right flank: 4, 20% (in deinonized water)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions
INDUCTION
100% (non‐irritating)
Topical application 0.5 g of test substance moistened with 0.5 ml deionized water per plaster (4 cm2) for 6h under fully occluded conditions, three times at intervals of one week. Skin grading 24 and 48h following patch removal
CHALLENGE
100% (non‐irritating); 14 days after the last induction exposure, application of the challenge patch on the shaved skin for 6h; skin evaluations 24 and 48h after patch removal
GRADING SYSTEM
Dermal reactions graded for erythema and edema by blind reading according to grading scale:
- No visible change: 0
- Discrete or patchy erythema: 1
- Moderated and confluent erythema: 2
- Intense erythema and swelling: 3
- not assessable: ? - Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylcinnamic aldehyde
Results and discussion
- Positive control results:
- The validity of the test system is confirmed by the periodically conducted positive control test using alpha-hexyl cinnamic aldehyde for the
Bühler test. No unforeseen circumstances were observed which might have affected the quality or integrity of the study.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
PRELIMINARY STUDY AND DOSE RANGE FINDING
No irritation at any dose. Concentration for induction and challenge: 100%
MAIN STUDY
No skin reaction observed in the control and test animals treated at the test item at 100% in de‐ionized water.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance "fully saturated TEA-Esterquat" is not a dermal sensitizer in this study.
- Executive summary:
In a dermal sensitization study with the fully saturated TEA-Esterquat, (containing approx 15 % IPA) male Moellegaard guinea pigs were tested using the method of Bühler according to OECD guideline 406. Positive control material was alpha-hexylcinnamic aldehyde.
Dermal induction was performed with undiluted test substance. None of the animals of the test or control group showed any positive skin reactions after challenge treatment with the undiluted test substance. The sensitisation rate at 24 h and at 48 h was 0 %.
In this study the test substance, “fully saturated TEA-Esterquat”, is considered to be a non-sensitizer.
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