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EC number: 807-015-9 | CAS number: 126437-91-0
- 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:
- other information
- Study period:
- 2004-02-17 to 2004-03-26
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented guideline conform, scientific GLP report. No toxicity data are available for 1-Tetradecanaminium, N,N,N-trimethyl-, methyl carbonate (CAS No. 126437-91-0, target substance) which is used as precursor for the N,N,N-trimethyltetradecan-1-aminium oxalate (CAS No. 154858-16-9, source substance). As the chemical structure of both chemicals is almost similar with the exception of the methyl carbonate anion for the target substance instead of the oxalate, read across is made to the source substance. The available studies from the source substance are sufficient to provide toxicological information of the target substance (refer to IUCLID point 13, Assessment reports.001- Read across justification).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Tetradecyltrimethylammonium oxalate
- IUPAC Name:
- Tetradecyltrimethylammonium oxalate
- Reference substance name:
- -
- EC Number:
- 453-080-8
- EC Name:
- -
- IUPAC Name:
- 453-080-8
- Reference substance name:
- 154858-16-9
- Cas Number:
- 154858-16-9
- IUPAC Name:
- 154858-16-9
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Constituent 3
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: HsdPoc:DH
- Sex:
- female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.04 % (test substance in deionized water)
epicutanous induction: 5 % (test substance in deionized water)
epicutanous challenge: 1 % (test substance in deionized water)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- intradermal induction: 0.04 % (test substance in deionized water)
epicutanous induction: 5 % (test substance in deionized water)
epicutanous challenge: 1 % (test substance in deionized water)
- No. of animals per dose:
- Control group: 5
Treatment group: 10 - Positive control substance(s):
- yes
- Remarks:
- ALPHA-HEXYL CINNAMIC ALDEHYDE
Results and discussion
- Positive control results:
- Positve control assay with Alpha-hexyl cinnamic aldehyde
Challenge treatment - control and treatment group:
25 % Alpha-hexyl cinnamic aldehyde in polyethylene glycole 400 (day 22)
Treated area: left flank
Time of observation: approx. 24 hours after removal of the patches (day :24).
24 hours after the challenge treatment, 9/10 animals of the treatment group (90 %) showed a positive reaction during the observation period. The corresponding 5 control animals did not show any reaction to treatment.
Time of observation: approx. 48 hours after removal of the patches (day :25).
48 hours after the challenge treatment, all ten animals of the treatment group (l00 %) showed a positive reaction during the observation period. The corresponding 5 control animals did not show any reaction to treatment.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% (test substance in deionized water)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% (test substance in deionized water). No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 % (test substance in deionized water)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 % (test substance in deionized water). No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No skin reactions were observed in the control group 24 and 48 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No skin reactions were observed in the control group 24 and 48 hours after removal of the occlusive bandage..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 25 %. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 24 hours after removal of the occlusive bandage..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25 %
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 25 %. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Discrete or patchy up to intense erythema and swelling were observed in the treatment group 48 hours after removal of the occlusive bandage..
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present OECD 406 study (Magnusson & Kligman), all of ten animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study Dodigen 5356 AS may cause sensitization by skin contact .
- Executive summary:
In order to evaluate the test substance for its skin sensitizing property, a test was performed in female guinea pigs according to the method of MAGNUSSON & KLIGMAN (OECD 406). Intradermal induction was performed using 0.04 % test substance in deionized water. Dermal induction treatment was carried out with 5 % test substance in deionized water. Challenge treatment was carried out with 1 % test substance in deionized water. Bodyweight of the treated animals were not impaired. The treated animals showed no clinical signs of intoxication throughout the study.
All animals of the treatment group (10/10) were positive in this test (100%) whereas all control animals (5/5) were negative.The validity of the test system is confirmed by the periodically conducted positive control test using Alpha-hexylcinnamaldehyde for the maximization test.
Based on the results of this study the test substance may cause sensitization by skin contact
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