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Diss Factsheets
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EC number: 951-929-1 | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide
- EC Number:
- 951-929-1
- Molecular formula:
- Not available. UVCB
- IUPAC Name:
- Reaction products of “Fatty Acids, C16-18 and C18-unsatd., Me esters; sulfuric acid and sodium hydroxide
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch: 2018060002
pH: 7.60
moisture content: 30.29%
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- The eyes collected from chickens obtained from a slaughterhouse (Etablissement Brun, 33820Etauliers, France) where they are killed for human consumption have been used for this assay.
The age and weight of the chickens used in this test method are that of spring chickens traditionally processed by a poultry slaughterhouse (i.e., approximately 7 weeks old, 1.5 - 2.5 kg).
Heads have been removed immediately after sedation of the chickens by electric shock, and incision of the neck for bleeding. The heads have been collected on 13 January 2020 at 8:28 am.
Because eyes were dissected in the laboratory, the intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with
physiological saline.
The eyes were enucleated at Phycher on 13 January 2020 at 10:00 am
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 μL
- Duration of treatment / exposure:
- 10 seconds
- Duration of post- treatment incubation (in vitro):
- Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180, and 240 minutes (± 5 minutes) after the post-treatment rinse.
- Number of animals or in vitro replicates:
- test item : 3 eyes
postive control : 3 eyes
negative control : 1 eye
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- mean
- Value:
- 0.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- mean
- Value:
- 0.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- mean
- Value:
- 4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- A histopathological examination was performed. The study meets the acceptance criteria as the negative control item and the positive control item fall within the Not Classified and Severe irritant classification, respectively. Following the application of the test item RICOIL EN, there was very slight (1/2) erosion of the
superficial part of the superficial corneal epithelium in 1 out 3 eyes examined. According to these findings, the test item was classified as negative for GHS Category 1 for non-extreme pH (2 < pH < 11.5) detergents and surfactants.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category).
No signal word and hazard statement are required.
However, these results are in contradiction with the results obtained with skin irritation in vitro (OECD 439). Indeed, the product has been classified in category 1 "Corrosive" or category 2 "Irritant" for its effects on the skin.
A histopathological examination was performed. The study meets the acceptance criteria as the negative control item and the positive control item fall within the Not Classified and Severe irritant classification, respectively. Following the application of the test item RICOIL EN, there was very slight (1/2) erosion of the superficial part of the superficial corneal epithelium in 1 out 3 eyes examined. According to these findings, the test item was classified as negative for GHS Category 1 for non-extreme pH (2 < pH < 11.5) detergents and surfactants.
Therefore, in accordance with the Regulation (EC) No. 1272/2008, the test item RICOIL EN is classified in the category “no prediction can be made”. It is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method.
As a conservative approach and in the absence of additional testing (in vitro and/or in vivo), the substance is classified as irritant to eye (category 2). - Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chicken eyes.
The test item was applied, as supplied, at the dose of 30 μL, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. Three eyes were treated in the same manner with a positive control and one eye with a negative control.
Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120, 180 and 240 minutes post-dose.
The experimental protocol was established in accordance with the O.E.C.D. Test Guideline No. 438 adopted 25 June 2018.
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 0.3, corresponding to ICE class I;
- mean score of fluorescein retention: 0.8, corresponding to ICE class II;
- maximal mean corneal swelling: 4%, corresponding to ICE class I.
The combination of the three endpoints for the test item was 2 x I, 1 x II.
The combination of the three endpoints for the positive control, 5% Benzalkonium chloride, was 3 x IV. Therefore, the positive control is classified as “Corrosive/Severe Irritant”, as expected.
The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as “No Category”, as expected.
In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions enable to conclude that the test item does not require classification for eye irritation and serious eye damage as defined by the UN GHS (No Category).
No signal word and hazard statement are required.
However, these results are in contradiction with the results obtained with skin irritation in vitro (OECD 439).
Indeed, the product has been classified in category 1 "Corrosive" or category 2 "Irritant" for its effects on the skin.
A histopathological examination was performed. The study meets the acceptance criteria as the negative control item and the positive control item fall within the Not Classified and Severe irritant classification, respectively. Following the application of the test item RICOIL EN, there was very slight (1/2) erosion of the superficial part of the superficial corneal epithelium in 1 out 3 eyes examined. According to these findings, the test item was classified as negative for GHS Category 1 for non-extreme pH (2 < pH < 11.5) detergents and surfactants.
Therefore, in accordance with the Regulation (EC) No. 1272/2008, the test item RICOIL EN is classified in the category “no prediction can be made”. It is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method.
As a conservative approach and in the absence of additional testing (in vitro and/or in vivo), the substance is classified as irritant to eye (category 2).
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