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EC number: 205-319-0 | CAS number: 138-24-9
- 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
Endpoint summary
Administrative data
Description of key information
By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence approach based on various test chemicals
- Justification for type of information:
- Weight of evidence approach based on various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence approach based on various test chemicals
- Principles of method if other than guideline:
- Weight of evidence approach based on various test chemicals
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence approach based on various test chemicals
- Justification for non-LLNA method:
- not specified
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N,N-trimethylanilinium chloride
- Molecular formula: C9H14N.Cl
- Molecular weight: 171.67 g/mol
- Smiles notation: [Cl-].C[N+](C)(C)c1ccccc1
- InChl : InChI=1/C9H14N.ClH/c1-10(2,3)9-7-5-4-6-8-9;/h4-8H,1-3H3;1H/q+1;/p-1
- Substance type: Organic
- Physical state: Solid - Species:
- other: humans, guinea pigs
- Strain:
- not specified
- Sex:
- male/female
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- not specified
- Concentration / amount:
- 0.1% test chemical (approx. 0.1 ml)
- Day(s)/duration:
- 3 times per week for 3 weeks and on Monday of week 4
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 10% solution of the test chemical
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- A cream containing 0.1% test chemical (approx. 0.1 ml)
- Day(s)/duration:
- 48 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 1 or 2% solutions of the test chemical
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 101 men and women (18-65 years old
2. no data available
3. no data available - Details on study design:
- Weight of evidence approach based on similar chemicals
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no signs of sensitization observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
- Executive summary:
The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.
Patch test was performed to determine the allergenic potential of the test chemical when applied to the skin as a part of the formulation.
A cream containing 0.1% test chemical (approx. 0.1 ml) was applied via a semi-occlusive patch to the back or arm of 101 men and women (18-65 years old).During a 6-week period. During the first 3 weeks of testing, patches were applied on Mondays, Wednesdays, and Fridays and removed 24 h after application.The last induction patches were applied on Monday of week 4 and removed 24 h later. Reactions were scored 48 h after patch removal.
After a rest period of one week, on the Monday of week 6, a challenge patch was placed on each subject (new site) and removed 48 h later. Reactions were scored 48 and 72 h after application.
Reactions were scored after patch removal according to the following scale: 0 (negative), 1 + (erythema), 2 + (erythema and edema or induration), 3 + (erythema, edema/induration and vesiculation), and 4 + (erythema, edema/induration, bulla, with or without ulceration).
No significant reactions were observed during induction or challenge phases. Hence, the test chemical was considered to be not sensitizing to skin when tested as a part of cream formulation.
This is supported by a study conducted on guinea pigs to observe the sensitization potency of test chemical. The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.
The above results are further supported by a skin sensitization study conducted in guinea pigs to observe the skin sensitization effects of test chemical.
In this study, the test animals were treated dermally with 10% solution of the test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of the test chemical.
Since the test chemical failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.
By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The dermal sensitization potential of the test chemical is being estimated based on the experimental data for the various test chemicals.
Patch test was performed to determine the allergenic potential of the test chemical when applied to the skin as a part of the formulation.
A cream containing 0.1% test chemical (approx. 0.1 ml) was applied via a semi-occlusive patch to the back or arm of 101 men and women (18-65 years old).During a 6-week period. During the first 3 weeks of testing, patches were applied on Mondays, Wednesdays, and Fridays and removed 24 h after application.The last induction patches were applied on Monday of week 4 and removed 24 h later. Reactions were scored 48 h after patch removal.
After a rest period of one week, on the Monday of week 6, a challenge patch was placed on each subject (new site) and removed 48 h later. Reactions were scored 48 and 72 h after application.
Reactions were scored after patch removal according to the following scale: 0 (negative), 1 + (erythema), 2 + (erythema and edema or induration), 3 + (erythema, edema/induration and vesiculation), and 4 + (erythema, edema/induration, bulla, with or without ulceration).
No significant reactions were observed during induction or challenge phases. Hence, the test chemical was considered to be not sensitizing to skin when tested as a part of cream formulation.
This is supported by a study conducted on guinea pigs to observe the sensitization potency of test chemical. The test chemical could not elicit any sensitization reactions in treated animals. Hence the test chemical can be considered as non-sensitizing to skin of guinea pigs.
The above results are further supported by a skin sensitization study conducted in guinea pigs to observe the skin sensitization effects of test chemical.
In this study, the test animals were treated dermally with 10% solution of the test chemical during induction. After induction, treated animals were dermally exposed to challenge concentration of 1 or 2% solutions of the test chemical.
Since the test chemical failed to induce any cutaneous reaction at challenge concentrations, the test chemical was considered as not sensitizing to guinea pigs.
By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
By applying the weight of evidence approach, the test chemical can be estimated to be not sensitizing to skin. Comparing the annotations with criteria of CLP regulation, the test chemical can be classified under the category "Not Classified".
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