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EC number: 306-227-4 | CAS number: 96690-34-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 05 Sep 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
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 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- 26 July 2013
- Deviations:
- yes
- Remarks:
- no data on values (ranges) of historical positive and negative control are provided in the report
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, Germany
Test material
- Reference substance name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- EC Number:
- 306-227-4
- EC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
- Cas Number:
- 96690-34-5
- Molecular formula:
- C4H11O4P to C8H20O7P2 as representative molecular formula of the composition as specified in section 1.2
- IUPAC Name:
- Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates
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: Attenberger Fleisch GmbH & Co. KG, Germany
- Storage, temperature and transport conditions of ocular tissue: On the test day, fresh eyes were collected from the slautherhouse and were transported in HBSS containing Pen/Strep on ice to the laboratories.
- Time interval prior to initiating testing: Immediately after arrival of the eyes, cornea preparation was initiated.
- indication of any existing defects or lesions in ocular tissue samples: The eyes were carefully examined for defects and any defective eyes were discarded
- Indication of any antibiotics used: Yes
Test system
- Vehicle:
- other: sesame oil
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied in the test: 750 µL
- Concentration: 20% in sesame oil
VEHICLE
- Substance: sesame oil (Caelo)
- Amount(s) applied in the test: 750 µL
- Lot/batch no.: 12054501 - Duration of treatment / exposure:
- 4 h ± 5 min
- Number of animals or in vitro replicates:
- number of eyes for the test item: 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The tissue surrounding the eyeball was carefully pulled away and the cornea was excised leaving a 2 to 3 mm rim of sclera. The isolated corneas were stored in a petri dish containing HBSS.
QUALITY CHECK OF THE ISOLATED CORNEAS
Before the corneas were mounted in corneal holders with the endothelial side against the O-ring of the posterior chamber, a visual check was examined for defects and any defective cornea was discarded.
NUMBER OF REPLICATES
3 eyes for each test group
NEGATIVE CONTROL USED
0.9% physiological saline (AlleMan Pharma, Lot/batch no.: 111214)
SOLVENT CONTROL USED
sesame oil (Caelo, Lot/batch no.: 12054501)
POSITIVE CONTROL USED
20% Imidazole (Sigma, Lot/batch no.: 109K5306V) solution in physiological saline (0.9% NaCl)
APPLICATION DOSE AND EXPOSURE TIME
750 µL and 4 h ± 5 min for each test group
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least three times with Minimal Essential Medium (MEM)
- POST-EXPOSURE INCUBATION: 90 min
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: decreased light transmission with the aid of a microtiter plate reader (OD490)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
According to OECD 437, liquids are usually tested undiluted and corneas are exposed to the liquids for 10 min. However, the test item was too viscous to be directly applied to the corneas. On the demand of the sponsor, the test item was suspended in sesame oil and tested according to the protocol for solids. Therefore, imidazole was used as positive control, sesame oil was used as an additional negative control and the exposure period was expanded to 4 h instead of 10 min.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean value of 3 eyes
- Run / experiment:
- 4 h of exposure
- Value:
- 222.1
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- Since the IVIS was 222.1, the test substance was defined as a corrosive. The IVIS of the positive control was 158.55, thus higher than that of the historical control values (out of the two standard deviations of the current historical mean), but still regarded valid.
No further lesions of the isolated eyes were reported.
Any other information on results incl. tables
DATA EVALUATION
- Calculation of opacity values:
The opacity value was calculated according to the following steps:
i) opacity change = final opacity – initial opacity
ii) corrected opacity change = opacity change – mean opacity change of the negative control
iii) mean opacity value = mean of all corrected opacity changes per group
- Calculation of OD490 (optical density at 490 nm) values:
The permeability value was calculated according to the following steps:
iv) OD490 change = OD490 – mean blank OD490
Any dilutions that were made to bring the OD490 values into the linear range of the spectrophotometer (OD490 should be less than 1.500), were taken into account by multiplying the OD490 value of the dilution by the dilution factor.
v) corrected OD490 change = OD490 change – mean OD490 change of negative control
vi) mean OD490 value = mean of all corrected OD490 changes per group
- Calculation of the IVIS (in-vitro irritancy score) values:
The In-Vitro Irritancy Score (IVIS) was calculated as follows:
IVIS per cornea per group = mean corrected opacity change + (15 x mean corrected OD490 change)
- Evaluation criteria:
Test substance with an IVIS ≥ 55.1 was regarded as severe irritant/corrosive and labelled Category 1.
- Acceptance criteria:
OECD 437: “A test is considered acceptable if the positive control gives an IVIS that falls within two standard deviations of the current historical mean, which is to be updated at least every three months, or each time an acceptable test is conducted in laboratories where tests are conducted infrequently (i.e., less than once a month). The negative or solvent/vehicle control responses should result in opacity and permeability value that are less than the establisher upper limits for background opacity and permeability values for bovine corneas treated with the respective negative or solvent/vehicle control.”
RESULTS
Table 1. Opacity scores
Treatment group |
Cornea no. |
Initial opacity |
Final opacity |
Opacity change |
Corrected opacity change |
Mean corrected opacity change |
Test substance (20% in sesame oil) |
7 8 9 |
3 4 4 |
195 216 210 |
192 212 206 |
188.33 208.33 202.33 |
199.67 |
Negative control (0.9% NaCl) |
1 2 3 |
4 4 4 |
7 9 9 |
3 5 5 |
NA NA NA |
NA |
Negative control (sesame oil) |
10 11 12 |
4 5 5 |
8 10 7 |
4 5 2 |
NA NA NA |
NA |
Positive control (20% imidazole in 0.9% NaCl) |
4 5 6 |
5 5 5 |
151 174 136 |
146 169 131 |
141.67 164.67 126.67 |
144.33 |
NA = not applicable
Table 2. Permeability score
Treatment group |
Cornea no. |
OD490 value |
Corrected OD490 value |
Mean corrected OD490 value |
Test substance (20% in sesame oil) |
7 8 9 |
1.355 1.618 1.632 |
1.316 1.579 1.593 |
1.496 |
Negative control (0.9% NaCl) |
1 2 3 |
0.074 0.098 0.107 |
NA NA NA |
NA |
Negative control (sesame oil) |
10 11 12 |
0.043 0.020 0.053 |
NA NA NA |
NA |
Positive control (20% imidazole in 0.9% NaCl) |
4 5 6 |
1.034 0.878 1.211 |
0.941 0.785 1.118 |
0.948 |
NA = not applicable
Table 3. In vitro irritancy score (IVIS)
Treatment group |
Cornea no. |
Corrected opacity change |
Corrected OD490 |
IVIS per group |
mean |
||||
Test substance (20% in sesame oil) |
7 8 9 |
188.33 208.33 202.33 |
1.316 1.579 1.593 |
222.11 |
Positive control (20% imidazole in 0.9% NaCl) |
4 5 6 |
141.67 164.67 126.67 |
0.941 0.785 1.118 |
158.55 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- CLP: Cat. 1, H318
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