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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 274-625-4 | CAS number: 70495-37-3
- 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:
- key study
- Study period:
- 2019-05-07 to 2019-05-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 9th October 2017
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- 9th December 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ammonium 2-ethylhexyl sulphate
- EC Number:
- 274-625-4
- EC Name:
- Ammonium 2-ethylhexyl sulphate
- Cas Number:
- 70495-37-3
- Molecular formula:
- C8H18O4S.H3N
- IUPAC Name:
- ammonium 2-ethylhexyl sulfate
- Test material form:
- cream / paste
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Tumkur slaughter house
- Characteristics of donor animals: 3.5 to 4.5 years old
- Storage, temperature and transport conditions of ocular tissue: To prevent exposure of the eyes to potentially irritant substances, the heads of the animals were not rinsed with detergent. Eyes were enucleated as soon as possible after death and immersed in the Hank's Balanced Salt Solution (HBSS) with 1% antibiotics (Penicillin and Streptomycin) in a suitable container and were transported to the test facility by placing in cool packs.
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
- Concentration: 10% w/v
VEHICLE
- Amount applied: 750 µL of distilled water - Duration of treatment / exposure:
- The corneas were incubated for an exposure period of approximately 10 minutes. Similar procedure was followed for the vehicle and positive controls.
- Duration of post- treatment incubation (in vitro):
- 1 hour and 55 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- QUALITY CHECK OF THE ISOLATED CORNEAS
: Upon arrival to the test facility, eyes were examined for defects including opacity, scratches and neovascularization. Only corneas free of such defects were used in the experiment.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : No
SOLVENT CONTROL USED: Yes (distilled water)
POSITIVE CONTROL USED : Yes, Imidazole
APPLICATION DOSE AND EXPOSURE TIME : 750 µL, 10 min exposure
TREATMENT METHOD: closed chamber
REMOVAL OF TEST SUBSTANCE : After the exposure periode the test item and the vehicle and positive control substance were removed from the anterior chamber and the epithelium was washed with EMEM containing phenol red until no visual evidence of the test item was observed.
- POST-EXPOSURE INCUBATION: yes, 1 hour and 55 minutes
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
A test item was classified based on the obtained IVIS and categorized as mentioned below:
- Test item of IVIS score <3 would be considered as not requiring classification for eye irritation or serious eye damage according to UN GHS.
- Test item of IVIS score >3 and <55 would be considered as equivocal, subsequently testing with any other adequate method remains at the discretion of the sponsor.
- Test item of IVIS score >55 would be considered as severe irritant causing serious eye damage and classified as UN GHS category 1 without further testing.
A single testing run was considered as sufficient for assessment as the results were met according to the following criteria:
- Two of the three replicates did not give discordant predictions from the mean.
- None of the three replicates gave discordant prediction from the mean of all three rep-licates and the IVIS of the discordant replicate was not higher than 65.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean
- Run / experiment:
- 1-3
- Value:
- 47.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
Study Acceptance Criteria
The study was accepted:
- As the vehicle/negative control response resulted in opacity and
permeability values less than the established upper limits of background
opacity and permeability values for bovine corneas treated with the
respective negative/vehicle control.
- As the positive control gave an IVIS that falls within two standard
deviations of the historical mean.
Applicant's summary and conclusion
- Interpretation of results:
- other: Equivocal
- Conclusions:
- Based on the results obtained in the Bovine Corneal Opacity and Permeability Test, the test item Ammonium 2-ethylhexyl sulfate induced an IVIS of 47.4 after 10 minutes of treatment. As the test item induced an IVIS >3 and <55, the resulting classification is equivocal and no prediction can be made regarding the corrosivity or severe irritancy to Bovine corneas.
- Executive summary:
The test item, Ammonium 2-ethylhexyl sulfate was evaluated for ocular corrosivity or severe irritancy according to OECD guideline 437. Eyes of cattle were collected from a slaughter house by immersing them in the Hank's Balanced Salt Solution (HBSS) with antibiotics (penicillin and streptomycin) in a suitable container and transported to the test facility by placing on cool packs. Eye balls free of defects were selected for the experiment. Empty cornea holder's opacity with pre-warmed Eagle's Minimum Essential Medium was measured and the mean opacity value obtained was determined as I0. Cornea holders with selected Corneas were equilibrated at 32±1°C for 1 hour 3 minutes with Eagle's Minimum Essential Medium with 1% Fetal Bovine Serum supplemented with 1% antibiotics and baseline opacity was recorded for each cornea. Corneas with opacity units less than 7 were selected and used for the study and distributed for the treatment groups.
A volume of 750 µL of 10% w/v test item, vehicle (distilled water) and positive control (20% w/v imidazole) was introduced into anterior chamber in triplicates to the designated cornea holders and incubated at 32±1 °C for 10 minutes. Treated corneas were washed till no visual evidence of test item observed with EMEM containing phenol red and finally with EMEM without phenol red. The anterior chamber was then refilled with fresh EMEM without phenol red. Opacity was measured with the aid of opacitometer and permeability was determined spectrophotometrically at 490 nm (OD490) using 4 mg/mL sodium fluorescein, post incubation of 85 minutes at 32±1 °C.
The test item resulted in the mean corrected opacity and mean corrected permeability values of 36.93 and 0.700, respectively. The in vitro Irritancy Score (IVIS) of test item resulted in 47.4 and thus the result is considered as equivocal (no prediction can be made). Whereas the positive control resulted in mean corrected opacity and mean corrected permeability values of positive control are 83.56 and 1.601 respectively where the in vitro Irritancy Score (IVIS) of 107.6, indicating corrosivity or severe irritancy to Bovine cornea.
Based on the results obtained in the Bovine Corneal Opacity and Permeability Test, the test item Ammonium 2-ethylhexyl sulfate induced an IVIS of 47.4 after 10 minutes of treatment. As the test item induced an IVIS >3 and <55, the resulting classification is equivocal and no prediction can be made regarding the corrosivity or severe irritancy to Bovine corneas.
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.