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EC number: 404-740-9 | CAS number: 115895-09-5
- 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:
- from november 16th, 1988 to February 7th, 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the OECD guideline n°471.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 404-740-9
- EC Name:
- -
- Cas Number:
- 115895-09-5
- Molecular formula:
- C26H40Cl2O5
- IUPAC Name:
- ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate
- Details on test material:
- A c. 700 g sample of the test substance, a white powder designated
AF—366, was received from Fuji Photo Film B.V., Tilburg, The Netherlands
on September 19, 1988. The test substance was stored at ambient
temperature and in the dark, until use.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- The S—9 batch of October 11, 1988 contained 0.94 µmol cytochrome P—450 per gram protein.
- Test concentrations with justification for top dose:
- 0 µg per plate,
61.7 µg per plate,
185.2 µg per plate,
555.6 µg per plate,
1666.7 µg per plate,
5000.0 µg per plate.
Controlsopen allclose all
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: 1.0 µg per plate with the strains TA 1535 and TA 100, in the absence of S-9 mix.
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: 2.0 µg per plate with the stains TA 1538 and TA 98 in the absence of S-9 mix.
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Migrated to IUCLID6: 80.0 µg per plate with the stain TA 1537 in the absence of S-9 mix.
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 2.0 µg per plate with the stains TA 1535, TA 1538, TA98 and TA 100, 5.0 µg per plate with strain 1537 in the presence of S-9 mix.
- Details on test system and experimental conditions:
- Toxicity test
A preliminary test with 6 concentrations of the test substance and the
vehicle (DM50) as negative control was carried out to assess the toxicity
of the test substance for S. typhimurium TA 1535, TA 1537, TA 1538, TA 98
and TA 100, both in the absence and in the presence of the S—9 mix. The
toxicity test was carried out between November 16 and December 13, 1988.
Just prior to use, a stock solution containing 100.0 mg of the test
substance per ml was prepared in DMSO under gentie heating in a waterbath
at 50°C. For the other dose levels a series of stepwise dilutions — by a
factor 10 — in DMSO were prepared from the stock solution.
Briefly, the toxicity test was carried out as follows. To 2 ml molten top
agar (containing 0.6% Difco agar, 0.5% NaCl and 0.05 mM L—histidine.HCl/
0.05 mM biotin), maintained at 46°C, were added in this sequence: 0.1 ml
of a fully grown culture of the appropriate tester strain, 0.1 ml of the
appropriate solution of the test substance and 0.5 ml S—9 mix, if any. The
ingredients were thoroughly mixed and the mix was immediately poured onto
minimal glucose agar plates (1.5% Bacto—Difco agar in Vogel and Bonner
medium E with 2% glucose). After incubation for three days at 37°C, the
background lawn of bacterial growth was examined microscopically and the
his+ revertants were counted by hand.
The resuits show that the test
substance was not toxic for any of the Salmonella typhimurium strains,
either in the absence or in the presence of the S—9 mix. At the highest
concentration used (10.0 mg per plate) the test substance precipitated in
the plates. A slight precipitate was seen at a concentration of 1.0
mg/plate.
In view of these observations, 5.0 mg/plate was chosen as the highest
concentration for the mutagenicity assay, both in the absence and in the
presence of the S—9 mix.
Mutagenicity assay
The mutagenicity assays were carried out according to a protocol entitled
“Protocol for the examination of the mutagenic activity of AF—366 in the
Ames test”, which was approved by the sponsor on October 6, 1988. In both
experiments the plate—incorporation method with the histidine requiring
S. typhimurium mutants TA 1535, TA 1537, TA 1538, TA 98 and TA 100 as
indicator strains was applied. This assay has been described in detail by
Ames et al. (1975) and by Maron and Ames (1983). The mutagenicity assays
were carried out between January 31 and February 7, 1989.
Appropriate solutions of the test substance, containing 0, 0.6, 1.9, 5.6,
16.7 and 50.0 mg/ml, were prepared in DM50 just prior to use. The repeat
experiment was carried out with the same concentrations.
The reference mutagens used as positive controls were:
— sodium azide: 1.0 µg per plate with the strains TA 1535 and TA 100, in
the absence of the S—9 mix
— 2—nitrofluorene; 2.0 µg per plate with the strains TA 1538 and TA 98, in
the absence of the S—9 mix
— 9—aminoacridine: 80.0 µg per plate with strain TA 1537, in the absence
of the S—9 mix
— 2—aminoanthracene: 2.0 µg per plate with the strains TA 1535, TA 1538,
TA 98 and TA 100, 5.0 pg per plate with strain TA 1537, in the presence
of the S—9 mix.
Briefly, the mutagenicity test was carried out as follows. To 2 ml molten
top agar, maintained at 46°C, were added
in this sequence: 0.1 ml of the appropriate tester strain, 0.1 ml of the
appropriate solution of the test substance or the controls and 0.5 ml of
the S—9 mix, if any. The ingredients were thoroughly mixed and the mix was
immediately poured onto minimal glucose agar plates.
All determinations were made in triplicate. The plates were
incubated at 37°C for three days. Then the his+ revertants were counted by
hand. The background lawn of bacterial growth was exainined
microscopically.
S—9 and S—9 mix were checked for sterility.
The viable count of each culture was made by plating appropriate dilutions
of the cultures on nutrient broth agar plates. Each culture was exainined
for the nuxnber of spontaneous revertants, histidine requirement and sen—
sitivity to ampicillin, crystal violet and UV radiation.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Positive controls validity:
- valid
- Additional information on results:
- Evaluation of test results
A positive response in the assay system is taken to be a two—fold or
greater increase in the mean nuinber of revertant colonies appearing in the
test plates over and above the background spontaneous reversion rate
observed with the vehicle, together with evidence of a dose—response.
Results
From the resuits obtained in both experiments it appeared that incubation
of the test substance with the bacteria did not increase the number of
his+ revertants with S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 or
TA 100, either in the absence or in the presence of the S—9 mix.
At the two higher concentrations used, the test substance precipitated in
the plates.
The positive controls used in the present assays gave the expected strong
increase in the number of his+ revertants, both in the absence and in the
presence of the S—9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
From the above findings it is concluded that AF—366 did not show mutagenic
activity in Salmonella typhimurium TA 1535, Tl 1537, TA 1538, T 98 or
TA 100 either in the absence or in the presence of the S—9 mix, under the
conditions employed in this evaluation.
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