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EC number: 263-134-0 | CAS number: 61790-41-8
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From February to November 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, trimethylsoya alkyl, chlorides
- EC Number:
- 263-134-0
- EC Name:
- Quaternary ammonium compounds, trimethylsoya alkyl, chlorides
- Cas Number:
- 61790-41-8
- Molecular formula:
- Representative molecular formula of the major constituents, as the substance is an UVCB: C21H46Cl1N1 (C18 carbon chain) C21H44ClN (C18-unstatd. carbon chain)
- IUPAC Name:
- Quaternary ammonium compounds, trimethylsoya alkyl, chlorides
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propylene glycol
- Test material form:
- liquid
- Details on test material:
- Chemical name: Quaternary ammonium compounds, trimethylsoya alkyl, chlorides (TMAC S)
EC no.: 263-134-0
To the best of knowledge, the sample used is representative to the boundary composition shared and agreed by each registrant
Constituent 1
additive 1
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- corneas
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 5% (v/v) with concentrations of 60.3% and 3.015% active ingredient. (The diluted concentration (i.e. 3.015%) is equivalent to the maximum on-head hair colorant usage concentration).
- Duration of treatment / exposure:
- 10 seconds followed by rinsing with 20ml saline
- Duration of post- treatment incubation (in vitro):
- 0, 30, 75, 120, 180 and 240 minutes
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- undiluted test substance
- Value:
- 141
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- irritation index: 143
- Remarks on result:
- other: cornea: moderate erosion of the epithelium
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 5% (v/v) aqueous dilution
- Value:
- 55
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- irritation index: 143
- Remarks on result:
- other: very slight swelling, slight opacity and slight to moderate fluorescein retention
- Remarks:
- cornea: very slight or slight erosion of the epithelium
Any other information on results incl. tables
Results (details):
The undiluted test substance produced severe irritation with an irritation index of 141/200. Histological examination of the corneas revealed moderate erosion of the epithelium with no effects on the stroma and endothelium being observed. The 5% (v/v) aqueous dilution of the test substance caused very slight swelling (5%), slight opacity (1.0) and slight to moderate fluorescein retention (1.5). The calculated Irritation Index was 55/200. Histological examination of the corneas treated with the diluted material revealed very slight or slight erosion of the epithelium, with no effects on the stroma and endothelium being observed.
Result table
Treatment |
Maximum mean score for |
Irritation Categories* |
IrritationIndex |
Classification# |
||
Swelling % |
Opacity |
Fluorescein retention |
||||
Undiluted |
21 |
3 |
3 |
III;IV;IV |
141 |
Category 1 |
5% in sterile water |
5 |
1.0 |
1.5 |
I;II;II |
55 |
Not classified |
Negative control |
0 |
0.0 |
0.0 |
Not applicable |
Not applicable |
Not classified |
Positivecontrol |
23 |
3.0 |
3.0 |
III;IV;IV |
143 |
Category 1 |
*I = no effect, II = slight effect, III = moderate effect, IV = severe effect
#Classification according to EU CLP
Histology summary
Treatment |
Tissue |
Histological observations |
Undiluted |
1 |
Moderate erosion of the epithelium |
2 |
Moderate erosion of the epithelium |
|
3 |
Moderate erosion of the epithelium |
|
5% in sterile water |
1 |
Very slight erosion of the epithelium |
2 |
Very slight erosion of the epithelium |
|
3 |
Slight erosion of the epithelium |
|
Negative control |
1 |
No effects observed |
2 |
||
3 |
||
Positive control |
1 |
Moderate erosion of the epithelium |
2 |
Severe erosion of the epithelium |
|
3 |
Severe erosion of the epithelium |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- for the undiluted test substance
- Conclusions:
- Under the study conditions, the undiluted test substance induced irreversible effects on the eye and serious damage to the eye.
- Executive summary:
A study was conducted to determine the in vitro eye irritant potential of the test substance, TMAC S (60.3% active), according OECD 438 Guideline (isolated chicken eye method), in compliance with GLP. Isolated chicken eyes were exposed to the test substance for 10 seconds, which were followed by evaluations at 0, 30, 75, 120, 180 and 240 minutes. The test substance was applied on cornea either undiluted or at a concentration of 5% (i.e., equivalent to 60.3 and 3.015% a.i.). The undiluted test substance produced severe irritation with an irritation index of 141/200. Histological examination of the corneas revealed moderate erosion of the epithelium with no effects on the stroma and endothelium being observed. The 5% (v/v) aqueous dilution of the test substance caused very slight swelling (5%), slight opacity (1.0) and slight to moderate fluorescein retention (1.5). The calculated Irritation Index was 55/200. Histological examination of the corneas treated with the diluted material revealed very slight or slight erosion of the epithelium, with no effects on the stroma and endothelium being observed. Under the study conditions, the undiluted test substance induced irreversible effects on the eye and serious damage to the eye, while the 5% (v/v) aqueous dilution was evaluated to cause only minimal or transient irritation. Therefore, the test substance was concluded to be corrosive to eyes (SCCS, 2012).
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