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EC number: 939-607-9 | CAS number: 1474044-65-9
- 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

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:
- key study
- Study period:
- June 1, 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was equivalent to OECD Guideline 406.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- No information on reliability check. Induction concentration could have been higher: 0.2% caused slight erythema in 1 of the two animals in the range finding test. However, the study is still considered sufficient for the hazard identification.
- GLP compliance:
- no
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- EC Number:
- 263-038-9
- EC Name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- Cas Number:
- 61789-18-2
- IUPAC Name:
- 61789-18-2
- Test material form:
- other: Granular solid
- Details on test material:
- - Name of test material (as cited in study report): C12-14 alkyl trimethyl ammonium chloride. The chain length distribution is somewhat different compared with TMAC as described in section A2. The somewhat narrower chain length distribution does not influence the validity for the use of this study for the active substance TMAC. Performing a new test on TMAC would unnecessary harm animals without giving additional information
- Physical state: White granular solid
- Analytical purity: 100%
- Stability: stable
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Redfern Animal Breeders, Jasons Farm, Old Hay, Brenchley, Kent, UK
- Weight at study initiation: Young, withing range 300 – 400 g
- Sex: Male and female
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- For the determination of a non-irritating concentration: 0.1, 0.2, 0.5, 1.0, 5.0, 10 and 20.0 % w/v (0.4 ml was applied over 6 h)
Dermal induction: 1000 µg test substance / ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches
Challenge: 400 µg test substance/ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches on untreated other flank.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- For the determination of a non-irritating concentration: 0.1, 0.2, 0.5, 1.0, 5.0, 10 and 20.0 % w/v (0.4 ml was applied over 6 h)
Dermal induction: 1000 µg test substance / ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches
Challenge: 400 µg test substance/ml (0.4 ml, 0.1 % w/v) for 6 h under closed patches on untreated other flank.
- No. of animals per dose:
- Dose range finding: 16 animals (8 groups of 2 animals)
Treatment group: 20 animals (10 male, 10 female)
Controlgroup: 10 animals (5 male, 5 female)
Results and discussion
Any other information on results incl. tables
Results for dose range finding study:
Skin
reactions were scored after 24 h. Results:
20%: severe erythema 2/2;
10%: severe erythema 2/2;
5%:
severe- moderate 2/2;
1%:
severe- moderate 4/4;
0.5%: moderate-slight 2/2;
0.2%: slight erythema 1/2;
0.1%: No erythema 2/2.
Results for main study:
First grading: 0/20 (3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5). Second grading: 0/20 (no erythema was observed in any of the animals)
The test substance tested has a narrower chain length distribution compared to full coco. The results from this substance however are fully valid for evaluation of TMAC as:
- The tested substance constitutes already for 70% TMAC, without some additional shorter and longer chain lengths present..
Principally, aspects of sensitisation are related to possible reactivity and protein binding, which are properties that are independent to chain length.Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the Buehler test, the substance is considered to be non-sensitizing.
- Executive summary:
A study equivalent to the Buehler test protocol (OECD Guideline 406) was conducted to determine the sensitising potential of the read-across substance C12-18 TMAC (test conducted on C12-14 alkyl trimethyl ammonium chloride). The chain length distribution of the test substance is narrower than C12-18 TMAC, however, the study is considered valid to assess this endpoint, because the tested substance is a constitute of C12-18 TMAC (at 70%), without some additional shorter and longer chain lengths present, and principally, aspects of sensitisation are related to possible reactivity and protein binding, which are independent of chain length. A pre-test was conducted to determine non-irritating concentrations to use in the main study. For the main study the induction was carried out at: topical 0.1% w/v in aqueous ethanol for 6 hours, repeated after 7 and 14 days. Challenge was done two weeks after the last induction treatment (Day 28): control and test animals received 0.1% w/v in acetone for 6 hours on previously untreated site under closed patches. After 18 hours the sites were treated with depilatory cream, rinsed and dried. After 3 hours, challenge sites were evaluated for erythema on a scale of 0-3. Evaluation was repeated 24 hours later. Results of the first grading were: 0/20 (3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5). Second grading: 0/20 (no erythema was observed in any of the animals). Under the conditions of the Buehler test, the test substance was not sensitizing.
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