Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 306-238-4 | CAS number: 96690-44-7
- 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
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- Refer to section 13 for details on the read-across justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
- Reason / purpose for cross-reference:
- read-across source
- 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
- Remarks:
- GLP was not yet compulsory at date of study
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A LLNA was not conducted with the test substance as a Buehler test was already available allowing assessment of the skin sensitisation potential of the substance. Moreover, the test substance is corrosive hence any additional testing is not required as per Annex VII column 2 of REACH Regulation (1907/2006).
- 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 - 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. - 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) - Key result
- Reading:
- other: Mean scores
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1% w/v in acetone (challenge dose)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: 3/20 showed a grade of 0.5; in control 2/10 showed a grade 0.5
- Key result
- Reading:
- other: Mean scores
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.1% w/v in acetone (challenge dose)
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: no erythema was observed in any of the animals
- Key result
- Reading:
- other: Incidence
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: Incidence
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Under the conditions of the Buehler test, the test substance is considered to be non-sensitizing.
- Executive summary:
A study was conducted to determine the skin sensitising potential of the read across substance, C12 -14 TMAC, according to a method equivalent to OECD Guideline 406 (Buehler test protocol). A pre-test was conducted to determine the non-irritating concentrations to be used in the main study. For the main study the topical induction was carried out at 0.1% w/v in aqueous ethanol for 6 h, repeated after 7 and 14 d. Challenge was done two weeks after the last induction (Day 28). The control and test animals received 0.1% w/v test substance in acetone for 6 h on previously untreated site under closed patches. After 18 h the sites were treated with depilatory cream, rinsed and dried. After 3 h, challenge sites were evaluated for erythema on a scale of 0 -3. Evaluation was repeated 24 h 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 study conditions, the test substance was considered to be non-sensitising to skin(Jones, 1978).
Reference
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.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
A study was conducted to determine the skin sensitising potential of the read across substance, C12 -14 TMAC, according to a method equivalent to OECD Guideline 406 (Buehler test protocol). A pre-test was conducted to determine the non-irritating concentrations to be used in the main study. For the main study the topical induction was carried out at 0.1% w/v in aqueous ethanol for 6 h, repeated after 7 and 14 d. Challenge was done two weeks after the last induction (Day 28). The control and test animals received 0.1% w/v test substance in acetone for 6 h on previously untreated site under closed patches. After 18 h the sites were treated with depilatory cream, rinsed and dried. After 3 h, challenge sites were evaluated for erythema on a scale of 0 -3. Evaluation was repeated 24 h 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 study conditions, the test substance was considered to be non-sensitising to skin (Jones, 1978).
Justification for classification or non-classification
Based on the results of the read acoss study, the test substance, Quaternary ammonium compounds, C12-14 alkyltrimethyl, Me sulfates, does not warrant classification for skin sensitisation according to EU CLP (1272/2008/EC) criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.