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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 269-044-8 | CAS number: 68186-64-1
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2019-03-12 to 2019-03-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was stopped due to animal welfare reasons.
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 402 (Acute Dermal Toxicity)
- Version / remarks:
- 9 October 2017
- Deviations:
- no
- Remarks:
- The study was terminated after treating one animal due to animal welfare reasons.
- Qualifier:
- according to guideline
- Guideline:
- other: Council Regulation (EC) No 440/2008
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Phosphoric acid, 2-ethylhexyl ester, sodium salt
- EC Number:
- 269-044-8
- EC Name:
- Phosphoric acid, 2-ethylhexyl ester, sodium salt
- Cas Number:
- 68186-64-1
- Molecular formula:
- C8 H18 O . x H3 O4 P . x Na
- IUPAC Name:
- .
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90
- Females nulliparous and non-pregnant: yes
- Age at study initiation: young adult rats
- Weight at study initiation: between 200 g and 300 g
- Fasting period before study: no
- Housing: during acclimatization: 3 animals/cage, During the exposition the animal was housed individually.
- Diet: ad libitum ssniff® SM R/M-Z+H complete diet (ssniff Spezialdiäten GmbH, D-59494 Soest Germany)
- Water: tap water ad libitum)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): above 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: back
- % coverage: approximately 10 % area of the total body surface
- Type of wrap: Sterile gauze pads were placed on the skin of the rats. These gauzes were kept in contact with the skin by a patch with adhesive hypoallergenic plaster. The entire trunk of the animal was then wrapped with semi-occlusive plastic wrap for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing: with water
- Time after start of exposure: 24
- Duration of exposure:
- 24 h
- Doses:
- 200 mg/kg bw
- No. of animals per sex per dose:
- 1 (range finding in one female)
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: Due to animal welfare reasons, the animal had to be sacrificed on Day 2 (treatment Day was Day 0).
- Frequency of observations and weighing: the animal was observed 30 minutes, 2 h, 4 h and 6 h after dosing, and then daily thereafter - Statistics:
- not applicable
Results and discussion
- Preliminary study:
- The test item was applied in original form and left in contact with the skin for a 24 hours period. The observation period was three days (treatment day as Day 0 and posttreatment period as Day 1 and Day 2). The in-life phase was terminated on Day 2 and the study was stopped, because unexpected corrosive signs were found on the treated skin surface. Moderate to severe erythema and other signs as whitish colouration were observed on Day 1, 1 hour after the patch removal. Severe erythema, open wound, crust and necrosis were detected on Day 2. No death and any systemic toxic sign were found. The body weight loss (approx. 4.2%) was observed between the treatment day and Day 2. External macroscopic changes as open wound, crust and necrosis were found on the treated area of the animal.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Remarks on result:
- not determinable
- Mortality:
- not observed
- Clinical signs:
- other: No signs of systemic toxicity were observed. Local signs of corrosivity were found on the treated skin surface.
- Gross pathology:
- External macroscopic changes as open wound, crust and necrosis were found on the treated area of the animal.
Any other information on results incl. tables
Table 1:Findings in the treated animal
Dose |
Animal number |
Body weight (g) |
Death |
Systemic clinical signs |
Local signs |
|||||
Day 0 |
Day 2 |
30 min |
2 h |
4 h |
6 h |
Day 1 |
Day 2 |
|||
200 |
4142 |
215 |
206 |
* |
— |
— |
— |
— |
R3;Wc |
R4;W;P;N |
Remarks: * = Humanely killing
— = No data
R3 = Moderate erythema
R4 = Severe erythema
Wc = Whitish colouration
W = Open wound
P = Crust
N = Necrosis
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- As the study had to be terminated two days after treating one animal, no LD50 value could be determined.
- Executive summary:
The objective of the study was to assess the toxicity of test item when administered in a single dermal dose to rats at one or more defined dose levels.At first, the range-finding study was performed in one female Han:WISTrat. The starting dose was 200 mg/kg bw. The test item was applied in original form and left in contact with the skin for a 24 hours period. The observation period was three days (treatment day as Day 0 and post treatment period as Day 1 and Day 2). The in-life phase was terminated on Day 2 and the study was stopped, because unexpected corrosive signs were found on the treated skin surface. Moderate to severe erythema and other sign as whitish colouration were observed on Day 1, 1 hour after the patch removal. Severe erythema, open wound, crust and necrosis were detected on Day 2. No death and any systemic toxic sign were found. The body weight loss (approx. 4.2%) was observed between the treatment day and Day 2. External macroscopic changes as open wound, crust and necrosis were found on the treated area of the animal.The test item could not be classified into any toxicity category for acute dermal 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.