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EC number: - | 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to valid methods and considered reliable, adequate and relevant, but it was non-GLP and only limited data were provided.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- fatty acids, C16-C18 and C18 unsaturated isopentyl esters, epoxidized
- IUPAC Name:
- fatty acids, C16-C18 and C18 unsaturated isopentyl esters, epoxidized
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): PLS Green 5; Plastificante A; soiato de isopentila epoxidado- ésteres isopentilicos de ácidos graxos (óleo de soja) epoxidados
- Substance type: Organic UVCB
- Lot/batch No.:2010-02; No.CPS: 145/2010
- Physical state: liquid
- Expiration date of the lot/batch: Shelf life: 2 years
- Other: Production site: Mogi das Cruzes, São Paulo
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: young healthy adults
- Acclimation period: at least 5 days
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: • The untreated eye of the animal serves as control.
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- The observation period should be sufficient to evaluate the reversibility of the effects observed.
To determine the reversibility of eye effects, the animals should be observed for 21 days after the administration of test substance. If it is possible to determine the reversibility of these effects before 21 days, the test can be completed at this time, this period being not less than three days. The test was completed after 72 h observation. - Number of animals or in vitro replicates:
- preliminary test: 1
main test: 2 - Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): . The eyes of the animal should not be washed for the first 24 hours after application of the test substance, but the washing with saline solution 0.9% for better visualization of ocular reactions is allowed during readings. However, in the case of solid samples if the test substance has not been removed by physiological mechanisms one hour after administration, the eye of the animal may
be washed with 0.9% saline solution or distilled water
- Time after start of exposure: 24 hours
SCORING SYSTEM:
The readings of ocular reactions should be recorded in periods of 1, 24, 48, 72 hours and 7, 14 and 21 days (where applicable). A graduate of the intensity of ocular reactions will be recorded according to the following criteria:
Cornea opacity: intensity degree (readings should be made in the most dense areas)
Grade 0: Normal cornea: transparent with characteristic brilliance.
Grade 1: The loss of normal brightness is observed. The details of the iris are clearly visible, with diffuse opacity area.
Grade 2: Defined opacity areas are observed. The iris details are visible
Grade 3: Necrosis areas are observed. The iris details are not visible (the observer is still able to graduate iritis and pupillary response to light).
Grade 4: Corneal opacity is observed. The iris cannot be displayed (the observer is not able to graduate iritis or pupillary response to light).
* The corneal opacity area should be measured and recorded.
Iris
Grade 0: Normal iris
Grade 1: Sharply deep wrinkles, congestion, swelling, moderate hyperemia around the cornea. The animal exhibits reaction to light (pupillary reflex).
Grade 2: bleeding, complete destruction. The animal has no reaction to light (pupillary reflex).
Conjunctiva: hyperaemia
Grade 0: Normal. The conjunctiva is presented pink perilimbic without congestion. The vessels of the eyelid and bulbar conjunctiva are easily observable.
Grade 1: Hyperemic blood vessels of the conjunctiva of the eyelid. There is some congestion perilimbic.
Grade 2: Palpebral vessels of the conjunctiva are not easily discernible, with diffuse redness and at least 75% of the perilimbic region is congested.
Grade 3: Dark and intense redness across the conjunctiva. Presence of petechiae (points bleeding).
Chemosis: edema (refers to lids and / or nictitating membranes)
Grade 0: Absence of edema.
Grade 1: Mild edema without eversion of the eyelids (upper and lower eyelids are positioned as the normal eye).
Grade 2: Swelling with eversion of the eyelids, often the upper and lower eyelids are misaligned.
Grade 3: Swelling with eversion of the two eyelids (the borders of the eyelids don’t get together ).
Grade 4: Edema with upper eyelid eversion more pronounced than the lower eyelid (it is difficult to retract the eyelids and observe the perilimbic region).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 3
- Irritant / corrosive response data:
- "PLS Green 5" (pH = 5.0)was applied in the left eye of experimental animals. One hour after ocular application of the test substance hyperemia of the vessels of the palpebral conjunctiva (grade 1) was observed. The complete reversal of that eye reaction occurred 24 hours after initiation of the test (preliminary test). Since any additional ocular reactions were not detected for a period of 72 hours after the start of the test, the preliminary test was terminated. It is noteworthy that during the experimental period there were not observed any systemic reactions indicative of toxicity. In order to confirm the results obtained in the preliminary test, two additional animals were used undergoing similar experimental procedure (main test). As in the preliminary test, one hour after ocular application of the test substance hyperemia of the vessels of the palpebral conjunctiva (grade 1) was observed.
A complete reversal of that eye reaction occurred 48 hours after initiation of the test and there were not any systemic signs of toxicity observed . The product was therefore classified as slightly irritating and the test terminated 72 hours after application of the test substance.
Any other information on results incl. tables
Table 1. Values attributed to ocular reactions after exposure of the animal to “PLS Green 5” in the preliminary eye irritation test
Cage |
Animal |
Parameters |
1h |
24h |
48h |
72h |
14d |
21d |
4 |
4 |
Cornea |
0 |
0 |
0 |
0 |
- |
- |
Iris |
0 |
0 |
0 |
0 |
- |
- |
||
Conjunctiva redness |
1 |
0 |
0 |
0 |
- |
- |
||
Chemosis |
0 |
0 |
0 |
0 |
- |
- |
Table 2. Values attributed to ocular reactions after exposure of the animal to “PLS Green 5” in the main eye irritation test
Cage |
Animal |
Parameters |
1h |
24h |
48h |
72h |
14d |
21d |
5 |
5 |
Cornea |
0 |
0 |
0 |
0 |
- |
- |
Iris |
0 |
0 |
0 |
0 |
- |
- |
||
Conjunctiva redness |
1 |
0 |
0 |
0 |
- |
- |
||
Chemosis |
0 |
0 |
0 |
0 |
- |
- |
Table 3. Values attributed to ocular reactions after exposure of the animal to “PLS Green 5” in the main eye irritation test
Cage |
Animal |
Parameters |
1h |
24h |
48h |
72h |
14d |
21d |
6 |
6 |
Cornea |
0 |
0 |
0 |
0 |
- |
- |
Iris |
0 |
0 |
0 |
0 |
- |
- |
||
Conjunctiva redness |
1 |
0 |
0 |
0 |
- |
- |
||
Chemosis |
0 |
0 |
0 |
0 |
- |
- |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- "PLS Green 5" was slightly irritating to the rabbit eye under the conditions of this test.
- Executive summary:
PLS Green 5 (pH = 5.0) was applied in the left eye of three New Zealand rabbits. One hour after ocular application of the test substance hyperemia of the vessels of the palpebral conjunctiva (grade 1) was observed. The complete reversal of that eye reaction occurred 24 hours after initiation of the test (preliminary test). Since any additional ocular reactions were not detected for a period of 72 hours after the start of the test, the preliminary test was terminated. It is noteworthy that during the experimental period there were not observed any systemic reactions indicative of toxicity. In order to confirm the results obtained in the preliminary test, two additional animals were used undergoing similar experimental procedure (main test). As in the preliminary test, one hour after ocular application of the test substance hyperemia of the vessels of the palpebral conjunctiva (grade 1) was observed. A complete reversal of that eye reaction occurred 48 hours after initiation of the test and there were not any systemic signs of toxicity observed. Although the product case concluded to be slightly irritating, the mean scores of 24 -72h were 0 for all observation criteria, therefore classification is not needed.
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