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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 261-222-3 | CAS number: 58353-68-7
- 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
Key value for chemical safety assessment
Additional information
No data were available for registered substance, however data were available for read-across substance 'Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts'. Justification for read-across with category members is provided in Section 13.
Bacterial
mutation
The
read-across test substance was tested in a key Ames test (Flügge,
2013d). Test item containing 25.5% active ingredient was examined in the
5 Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535
and TA 1537 in two independent experiments, each carried out without and
with metabolic activation. The first experiment was carried out as a
plate incorporation test and the second as a preincubation test. The
test item was suspended in aqua ad iniectabilia. A correction
factor of 3.92 was used as the supplied test item contains 25.5% active
ingredient only. The vehicle served as the negative control. From a
preliminary test, cytotoxicity was noted at concentrations of 316 to
5000 µg/plate. Hence, 316 µg test item/plate were chosen as top
concentration for the main study in the plate incorporation test and in
the preincubation test. In the main test, six concentrations ranging
from 1.0 to 316 µg test item/plate were employed in the plate
incorporation test and in the preincubation test, each carried out
without and with metabolic activation. No increase in revertant colony
numbers as compared with control counts was observed for the test item,
tested up to a cytotoxic concentration of 316 µg/plate, in any of the 5
test strains in two independent experiments without and with metabolic
activation, respectively (plate incorporation and preincubation test).
The positive control items showed a significant increase in the number
of revertant colonies of the respective test strain and confirmed the
validity of the test conditions and the sensitivity of the test system.
In conclusion, no mutagenic effect was exerted in bacterial strains without and with metabolic activation, therefore no mutagenic potential is expected for registered stubstance.
Mammalian
gene mutation
In
a key in vitro mammalian gene mutation study with read-across substance
(Flügge, 2013e) test item containing 25.5% active ingredient was tested
for mutagenic potential in a gene mutation assay in cultured mammalian
cells (V79, genetic marker HPRT) both in the presence and absence of
metabolic activation. The duration of the exposure with the test item
was 4 hours or 24 hours in the experiments without S9 mix and 4 hours in
the experiments with S9 mix. The test item was suspended in aqua ad
iniectabilia. Aqua ad iniectabilia served as the vehicle
control. In the preliminary test the concentration of 167 µg/mL caused
complete cytotoxicity and test item precipitation. Hence, 125 µg active
ingredient/mL were employed as the top concentration for the
mutagenicity tests in the absence and in the presence of metabolic
activation. Concentrations of 7.81, 15.63, 31.3, 62.5 or 125 µg active
ingredient/mL were selected for the experiments without and with
metabolic activation, respectively. The mutation frequency of the
cultures treated were within the normal range of the vehicle controls.
Under the present test conditions, the test item tested up to cytotoxic
concentrations in the experiments without and with metabolic activation
was negative in the HPRT-V79 mammalian cell mutagenicity test conditions
where positive controls exerted potent mutagenic effects.
In conclusion, no mutagenic effect was exerted in mammalian V79 cells without and with metabolic activation, therefore no mutagenic potential is expected for registered stubstance.
Chromosomal
aberration
A
key in vitro micronucleus test was conducted with read-across substance
using human peripheral lymphocytes both in the presence and absence of
metabolic activation by a rat liver post-mitochondrial fraction (S9 mix)
from Aroclor 1254 induced animals (Flügge, 2013f). The test was carried
out with read-across test substance containing 25.5% active ingredient,
employing 2 exposure times without S9 mix: (4 hours and 20 hours) and
one exposure time with S9 mix ( 4 hours, repeated). The harvesting time
was 24 hours after the end of exposure. Each treatment was conducted in
duplicate. The test item was dissolved in aqua ad iniectabilia,
which also served as the vehicle control. Based on a preliminary
experiment, cytotoxicity was noted starting at the concentration of 250
µg active ingredient/mL. Hence, 255 µg/mL were employed as the top
concentration for the main tests without and with metabolic activation
(4-hour exposure), 125 µg/mL for the test without metabolic activation
with 20 hour exposure. There was no increase in micronuclei up to the
cytotoxic concentration when compared to control both with and without
metabolic activation. Under the present test conditions, the test item
tested up to cytotoxic concentrations, in the absence and in the
presence of metabolic activation employing two exposure times (without
S9) and one exposure time (with S9) revealed no indications of any
chromosomal damage in the in vitro micronucleus test. In the same test,
Mitomycin C and cyclophosphamide induced significant damage.
In conclusion, no chromosomal aberration was exerted in human peripheral lymphocytes without and with metabolic activationt, therefore no clastogenic potential is expected for registered stubstance.
Conclusion
Standard
information requirements according to REACH Guidance Part 3 R7a were
fulfilled for genotoxicity testing, including bacterial and mammalian
mutagenicity and chromosomal aberration. Based on the available results,
there were no indications of mutagenicity or genotoxicity, and no
further testing is needed. The substance can be considered to have no
mutagenic or genotoxic potential.
Justification for selection of genetic toxicity endpoint
Although the Ames bacterial mutagenicity test was selected, the mammalian gene mutation and chromosome aberration tests were equally important.
Short description of key information:
Data were available from read-across substance 'Butanoic acid, 4-amino-4-oxo-2(or 3)-sulfo-, N-(C16-C18 (even numbered), C18 unsaturated alkyl), disodium salts'. In a key Ames test no increase in mutations were observed in different Salmonella typhimurium strains with and without metabolic activation up to cytoxic concentration of 316 µg/plate. In a key mammalian gene mutation test in HPRT cells, the test item did not induce mutations in the absence and presence of metabolic activation when tested up to cytotoxic concentrations of 125 µg/mL. In a key in vitro Micronucleus study in human peripheral lymphocytes, there was no increase in micronuclei up to the cytotoxic concentration when compared to control both with and without metabolic activation up to cytotoxic concentrations of 255 µg/mL (4 h exposure) or 125 µg/mL (20 h exposure). There were no indications of any chromosomal damage in the in vitro micronucleus test. In the same test, Mitomycin C and cyclophosphamide induced significant damage.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on these results from structurally simliar read-across substance and according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008), the registered substance does not have to be classified and has no obligatory labelling requirement for genetic toxicity.
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.