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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 943-175-7 | 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
- Study period:
- 2015-19-03 to 2015-08-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
- Version / remarks:
- adopted 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria
- EC Number:
- 943-175-7
- IUPAC Name:
- Rhamnolipids: fermentation products of glucose with Pseudomonas bacteria
Constituent 1
- Specific details on test material used for the study:
- Substance was tested at different pH values and various concentrations:
pH 5.8; 100%, 50% and 10%
pH 7.0; 100%, 50% and 10%
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: ROSS, spring chickens from poultry slaughterhouse v.d. Bor, Nijkerkerveen, the Netherlands
- Age at study initiation: Approximately 7 weeks old
- Weight at study initiation: body weight range approximately 1.5 - 2.5 kg
Heads of the animals were cut off immediately after sedation of the animals by electric shock and incision of the neck for bleeding, and before they reached the next station on the process line. The heads were placed in small plastic boxes on a bedding of paper tissues moistened with isotonic saline. Next, they were transported to the testing facility. During transportation, the heads were kept at ambient temperature.
Within 2 hours after kill, eyes were carefully dissected and placed in a superfusion apparatus. Eyes with a corneal thickness deviating more than 10% of the average corneal thickness of the eyes, eyes that showed opacity (score higher than 0.5), were unacceptably stained with fluorescein (score higher than 0.5), or showed any other signs of damage were rejected and were replaced.
After an equilibration period of 45-60 minutes, the corneal thickness of the eyes was measured once more to determine the zero reference value for corneal swelling calculations.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- liquids used as supplied by the sponsor
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30 mg for solid test substance; 30 µL for liquid preparations - Duration of treatment / exposure:
- 10 s
- Observation period (in vivo):
- eyes were examined at approximately 0, 30, 75, 120, 180 and 240 minutes after treatment
- Number of animals or in vitro replicates:
- negative control (physiological saline, 30 µL): 2
positive control (NaOH, 30 mg): 3
test group: 3 per concentration / pH - Details on study design:
- REMOVAL OF TEST SUBSTANCE - Washing (if done): 20 mL saline
- Time after start of exposure: 10 s
SCORING SYSTEM: according to ICE classification criteria OECD TG 438
TOOL USED TO ASSESS SCORE: slit lamp microscope / fluorescein
At time t=0, i.e. immediately after the zero reference measurement, the following procedure was applied for each test eye:
The clamp holding the test eye was placed on paper tissues outside the chamber with the cornea facing upwards. Next, three corneas were treated with 30 mg test item. After an exposure period of 10 seconds, the corneal surface was rinsed thoroughly with 20 mL of isotonic saline at ambient temperature. After rinsing, each eye in the holder was returned to its chamber. The eyes were examined at 0, 30, 75, 120, 180 and 240 minutes after treatment. All examinations were performed with a slit-lamp microscope. Fluorescein retention was scored only at 30 minutes after treatment.
After the final examination, the test and control eyes were preserved in a neutral aqueous phosphate-buffered solution of 4% formaldehyde.
The tissues selected were embedded in paraffin wax, sectioned at 5 μm and stained with Periodic Acid-Schiff for histopathology examination. Ocular effects were evaluated using the endpoints of corneal thickness (swelling), corneal opacity and fluorescein retention.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 100% pH 5.8
- Value:
- 33
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 100% pH 5.8
- Value:
- 3.5
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 100% pH 5.8
- Value:
- 2.8
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 100 % pH 7
- Value:
- 16
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 100 % pH 7
- Value:
- 2.3
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 100 % pH 7
- Value:
- 2.2
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 50% pH 5.8
- Value:
- 28
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 50% pH 5.8
- Value:
- 3
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 50% pH 5.8
- Value:
- 3
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
The test item at 50% / pH 5.8 and 100% / pH 5.8 caused corneal effects leading to Category 1 classification, consisting of moderate or severe corneal swelling (28 and 33%), severe or severe to very severe opacity (mean score of 3.0 or 3.5) and severe or moderate to severe fluorescein retention (mean score of 2.8 or 3.0). In addition, loosening (veil-like) of epithelium was observed.
Microscopic examination of the corneas treated with teh test item at 100% / pH 5.8 revealed very slight, slight or severe erosion and very slight vacuolation (one cornea top region; one cornea low region) of the epithelium. In addition, the epithelium top ceillayer was hypertrophic in one cornea.
Microscopic examination of the corneas treated with the test item at 50% / pH 5.8 revealed slight or moderate erosion and slight vacuolation (one cornea mid region) of the epithelium. In addition, the epithelium top cell layer was hypertrophic all corneas.
The AlSE histopathology criteria for upgrading to category 1 were met, but did not need to be applied, because it was already classified as category 1 on the basis of the slit-Iamp observations.
The test item at 100% / pH 7.0 caused corneal effects leading to Category 2/2A classification, consisting of slight corneal swelling (16%), moderate or moderate to severe opacity (mean score of 2.3) and moderate or moderate to severe fluorescein retention (mean score of 2.2). In addition, loosening (veil-like) of epithelium was observed.
Microscopic examination ofthe corneas treated with the test item at 100% / pH 7.0 revealed moderate or severe erosion, slight necrosis (one cornea) and very slight (one cornea low region) or slight (one cornea mid region) vacuolation of the epithelium.
According to the AlSE histopathology criteria, upgrading to category 1 on basis of the histopathology of the corneas is required.
DEMONSTRATION OF TECHNICAL PROFICIENCY:
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
The negative control eyes did not show any corneal effect and demonstrated that the general conditions during the tests were adequate. The positive control NaOH caused (very) severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants. Microscopic examination of the corneas treated with the negative control (saline) did not reveal any abnormalities. The positive control NaOH caused very slight, moderate or severe erosion and slight necrosis of the epithelium, and endothelial necrosis (one cornea).
Any other information on results incl. tables
Summary results of the slit-Iamp examination
Test material |
Maximum mean score for:
|
Irritation categories1 |
Irritation Index2 |
Classifications (EU-CLP3/UN-GHS4)
|
||
Swelling |
Opacity |
Fluorescin retention |
||||
test item(pH 5.8)_100% |
33 |
3.55 |
2.8 |
IV;IV;IV |
159 |
1/1 |
test item (pH 5.8)_50% |
28 |
3.05 |
3.0 |
III;IV;IV |
148 |
1/1 |
test item (pH 5.8)_10% |
6 |
1.35 |
2.0 |
II;II;III |
72 |
2/2B |
test item (pH 7.0)_100% |
16 |
2.35 |
2.2 |
II;III;III |
106 |
17/17 |
test item (pH 7.0)_50% |
8 |
1.35 |
2.0 |
II;II;III |
74 |
2/2B |
test item (pH 7.0)_10% |
8 |
1.55 |
2.0 |
II;II;III |
78 |
2/2B |
NaOH (positive control) |
46 |
4.06 |
3.0 |
IV;IV;IV |
186 |
1/1 |
1 I= no effect; II = slight effect; III = moderate effect; IV = severe effect.
2 Irritation Index = maximum mean corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20)
3 EU-CLP: NC = not classified; Category 2 = Irritating to eyes; Category 1 = irreversible effects on the eye/serious damage to the eye. Regulation (EC)
No 1272/2808 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Oirectives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2806.
4 UN-GHS: NC = not classified; Category 2B = mild irritant, causes eye irritation; Category 2A = irritant, causes eye irritation; Category 1 = irreversible effects on the eye/serious damage to the eye. United Nations-Economic Commission for Europe (UN/ECE) (2003). Globally Harmonised System of
Classification and Labelling of Chemicals (GHS). UN, New York and Geneva, 2007.
5 Loosening (veil-like) of epithelium
6 Severe loosening of epithelium
7 According to the AlSE histopathology criteria, upgrading to category 1 on basis of the histopathology of the corneas is required.
Individual histopathological findings
Test material
|
Eye no |
Epithelium |
Stroma |
Endothelium |
|||||||
Erosion |
Necrosis |
Vacuolation |
Notes |
Disorder of fibers |
Pyknotic nuclei |
|
|||||
top |
mid |
low |
outer region (adjacent to epithelium) |
inner region (adjacent to endothelium) |
|||||||
test item 100% pH 5.8 |
4 |
3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
6 |
1 |
- |
- |
- |
½ |
- |
- |
- |
- |
- |
|
8 |
½ |
- |
½ |
- |
- |
‡ |
- |
- |
- |
- |
|
test item 100% pH 7.0 |
5 |
3 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
7 |
2 |
1 |
- |
1 |
- |
- |
- |
- |
- |
- |
|
9 |
2 |
- |
- |
- |
½ |
- |
- |
- |
- |
- |
|
NaOH (positive control) |
1 |
3 |
1 |
- |
- |
- |
- |
- |
- |
- |
P |
2 |
2 |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
3 |
½ |
1 |
- |
- |
- |
- |
- |
- |
- |
- |
|
Saline (negative control) |
10 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- = not observed; P = present; 1/2 = very slight; 1 = slight; 2 = moderate; 3 = severe;
† = scored in the top/mid/low section of the epithelium; ‡ = epithelium top cell layer hypertrophic
Test material
|
Eye no |
Epithelium |
Stroma |
Endothelium |
|||||||
Erosion |
Necrosis |
Vacuolation |
Notes |
Disorder of fibers |
Pyknotic nuclei |
|
|||||
Top |
mid |
low |
outer region (adjacent to epithelium) |
inner region (adjacent to endothelium) |
|||||||
test item 50% pH 5.8 |
21 |
2 |
- |
- |
- |
- |
‡ |
- |
- |
- |
- |
25 |
1 |
- |
- |
- |
- |
‡ |
- |
- |
- |
- |
|
29 |
2 |
- |
- |
1 |
- |
‡ |
- |
- |
- |
- |
|
test item 50% pH 7.0 |
22 |
½ |
- |
1 |
- |
- |
‡ |
- |
- |
- |
- |
26 |
½ |
- |
1 |
- |
- |
‡ |
- |
- |
- |
- |
|
30 |
½ |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|
test item 10% pH 5.8 |
23 |
½ |
- |
- |
- |
- |
‡ |
- |
- |
- |
- |
27 |
½ |
1 |
- |
- |
- |
‡ |
- |
- |
- |
- |
|
31 |
½ |
1 |
½ |
- |
- |
‡ |
- |
- |
- |
- |
|
test item 10% pH 7.0 |
24 |
½ |
½ |
½ |
- |
- |
‡ |
- |
- |
- |
- |
28 |
½ |
1 |
- |
- |
- |
|
- |
- |
- |
- |
|
32 |
½ |
½ |
- |
- |
- |
‡ |
- |
- |
- |
- |
|
Saline (negative control) |
33 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- = not observed; P = present; 1/2 = very slight; 1 = slight; 2 = moderate; 3 = severe;
† = scored in the top/mid/low section of the epithelium; ‡ = epithelium top cell layer hypertrophic
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results from this Isolated Chicken Eye test, the testsubstance Rhamnolipids applied neat (100%) is considered "Irreversible effects on the eye/serious damage to the eye" (Category 1) under the experimental conditions described in this report (pH 7 and pH 5.8).
Based on the results from this Isolated Chicken Eye test, the testsubstance Rhamnolipids applied as a 50% dilution at pH 5.8 is considered "Irreversible effects on the eye/serious damage to the eye" (Category 1) under the experimental conditions described in this report. - Executive summary:
In an Isolated Chicken Eye (ICE) test according to OECD Guideline 438 (adopted 26 July 2013), the eye irritation potential of the testsubstance Rhamnolipids was assessed at different concentrations and pH vaues. In addition, the test included a negative control (saline) and a positive control (NaOH). Chicken eyes were obtained from slaughter animals used for human consumption.
The isolated chicken eyes were exposed to a single application of 30 mg for 10 seconds followed by a 20 mL saline rinse. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells. In addition, histopathology of the corneas was performed.
The test item at 50% / pH 5.8 and 100% / pH 5.8 caused corneal effects leading to Category 1 classification, consisting of moderate or severe corneal swelling (28 and 33%), severe or severe to very severe opacity (mean score of 3.0 or 3.5) and severe or moderate to severe fluorescein retention (mean score of 2.8 or 3.0). In addition, loosening (veil-like) of epithelium was observed.
Microscopic examination of the corneas treated with the test item at 100% / pH 5.8 revealed very slight, slight or severe erosion and very slight vacuolation (one cornea top region; one cornea low region) of the epithelium. In addition, the epithelium top ceillayer was hypertrophic in one cornea.
Microscopic examination of the corneas treated with the test item at 50% / pH 5.8 revealed slight or moderate erosion and slight vacuolation (one cornea mid region) of the epithelium. In addition, the epithelium top cell layer was hypertrophic all corneas.
The AlSE histopathology criteria for upgrading to category 1 were met, but did not need to be applied, because it was already classified as category 1 on the basis of the slit-Iamp observations.
The test item at 100% / pH 7.0 caused corneal effects leading to Category 2/2A classification, consisting of slight corneal swelling (16%), moderate or moderate to severe opacity (mean score of 2.3) and moderate or moderate to severe fluorescein retention (mean score of 2.2). In addition, loosening (veil-like) of epithelium was observed.
Microscopic examination of the corneas treated with the test item at 100% / pH 7.0 revealed moderate or severe erosion, slight necrosis (one cornea) and very slight (one cornea low region) or slight (one cornea mid region) vacuolation of the epithelium.
According to the AlSE histopathology criteria, upgrading to category 1 on basis of the histopathology of the corneas is required.
The negative control eye did not show any corneal effect and demonstrated that the general conditions during the tests were adequate.
The positive control NaOH caused severe corneal effects and demonstrated the ICE test valid to detect severe eye irritants.
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.