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EC number: 939-479-4 | CAS number: 1471311-60-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 September to 28 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1):
- IUPAC Name:
- Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1):
- Test material form:
- liquid: viscous
- Details on test material:
- - Name of test material (as cited in study report): Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1)
- Name of product (as cited on Certificate of Analysis): MARLON AMI 80
- Substance type: technical product
- Physical state: yellow-brown viscous liquid
- Analytical purity: 78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol (communication with sponsor)
- Lot No.: 126
- Expiration date of the lot: 01 June 2013
- Storage condition of test material: room temperature in the dark
- Other: data not verified by the laboratory; identity details were supplied by the Sponsor
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 male rat liver microsomal fraction; animals induced with phenobarbitone/b-naphthoflavone
- Test concentrations with justification for top dose:
- Exp. I & II: 5, 15, 50, 150, 500, 1500 and 5000 ug/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
- Justification for choice of solvent/vehicle: based on solubility testing. The test material was fully soluble in water at 50 mg/ml.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: exp. I in agar (plate incorporation), exp.II pre-incubation method; according to the OECD Guideline
DURATION
- Preincubation period (exp. II): 20 min
- Expression time (cells in growth medium): 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: bacterial background lawn - Evaluation criteria:
- Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al (1989)).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item will be considered non-mutagenic in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgement about test item activity. Results of this type will be reported as equivocal. - Statistics:
- UKEMS (Mahon GAT et al 1989; Analysis of data from microbial colony assays. In: Statistical Evaluation of Mutagenicity Test Data, UKEMS sub-committee on guidelines for mutagenicity testing)
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
The strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). The amino acid supplemented top agar and S9-mix used in both experiments was shown to be sterile. The culture density for each bacterial strain was also checked and considered acceptable.
Precipitation: no precipitation up to 5000 ug/plate
Solubility in water: the test material was fully soluble at 50 mg/ml.
Preliminary test: Marlon AMI 80 was toxic to TA100 at 1500 and 5000 ug/plate, and to WP2uvrA at 5000 ug/plate
Positive and negative control results were considered valid.
Cytotoxicity: reduction of the bacterial background lawn was seen from 500 mg/plate onwards without S9 and from 1500 ug/plate onwards when S9 was applied, but mostly in the Salmonella strains.
Mutagenicity: no significant increases in the revertant colonies were seen at any dose level, both with and without metabolic activation - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Detailed results can be seen in the attached document.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this test the test material does not induce any mutations in bacterial strains, when tested up to cytotoxic concentrations, both with and without metabolic activation. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA1535, TA1537, TA98, and TA100 of S. typhimurium and strain WP2urvA of E. coli were exposed to Marlon AMI 80 (78% benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with isopropanolamine (1:1) in 22% 1,2-propylene glycol)at concentrations of 5, 15, 50, 150, 500, 1500 and 5000 µg/plate in the presence and absence of mammalian metabolic activation (S9 microsomal liver fraction, taken from male rats induced with phenobarbitone/b-naphthoflavone.The product was tested up to cytotoxic concentrations based on a preliminary toxicity test. The results showed a negative response, i.e. no significant increase in the number of revertants was recorded at any dose level tested. The positive controls induced the appropriate responses in the corresponding strains
This study is classified asacceptable. It satisfies the requirement for Test Guideline OECD 471 forin vitromutagenicity (bacterial reverse gene mutation) data.
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