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Diss Factsheets
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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
Endpoint summary
Administrative data
Description of key information
Based on the results of the performed acute dermal toxicity study and the performed BCOP test it is concluded that the substance is not irritating/corrosive to skin and not irritating/corrosive to eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 22, 2014 - September 23, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD and/or EC guidelines and according to GLP principles.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- (2013)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- (2010)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: The Ocular Toxicity Working Group (OTWG) of ICCVAM and NICEATM, Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The BCOP Test Method, March 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) protocol 127. Bovine Opacity and Permeability (BCOP) Assay, 2006
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992
- Deviations:
- no
- GLP compliance:
- yes
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL of a 20% (w/w) suspension in the vehicle per cornea
NEGATIVE CONTROL
- Amount applied: 750 µL of the vehicle per cornea
POSITIVE CONTROL
- Amount applied: 750 µL of a 20% (w/v) Imidazole solution in the vehicle per cornea - Duration of treatment / exposure:
- 4 hours
- Details on study design:
- TEST SITE
- Isolated bovine cornea
- Corneas that had an initial opacity reading higher than 7 were not used
- Three corneas were used for each treatment group, at random.
REMOVAL OF TEST SUBSTANCE
- Washing: yes, with MEM+phenol red
- Time after start of exposure: 4 hours (at 32 °C)
SCORING SYSTEM:
- After exposure, the cornea is thoroughly rinsed to remove the test substance followed by immediate opacity measurement
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein (Merck) was evaluated, after another incubation period of 90 minutes at 32 °C. OD490 values of less than 1500 were used in the calculation.
- The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate the mean in vitro score:
Mean in vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
- Opacity and permeability values were also evaluated individually
TOOL USED TO ASSESS SCORE:
- Opacitymeter and microplate reader
DATA EVALUATION:
- A test substance that induces a mean IVIS >55 is classified with Eye Irr. Cat. 1 in accordance with the CLP Regulation
- A test substance that induces a mean IVIS ≤ 3 is not classified for Eye irritation in accordance with the CLP Regulation
- For a test substance that induces a mean IVIS of >3 - ≤55, it cannot be concluded whether the substance needs to be classified or not and for these substances, more (in vivo) information is needed - Irritation parameter:
- other: In vitro irritancy score (IVIS)
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- 0.4
- Remarks on result:
- other: Negative control: 0; Positive control: 139
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of a Bovine Corneal Opacity and Permeability test in which L 130 (a solid; tested in a 20% (w/w) suspension) did not induce ocular irritation (mean in vitro irritancy score of 0.4), L 130 does not need to be classified for Eye irritation in accordance with the CLP Regulation.
- Executive summary:
Using the Bovine Corneal Opacity and Permeability test (BCOP test) L 130 was screened for its eye irritancy potential in accordance with OECD 437 and according to GLP principles. The substance was applied as a 20% (w/w) suspension (750 µL) directly on top of the corneas. Adequate negative and positive controls were included. The substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.4 after 240 minutes of treatment. Since the substance induced a mean IVIS ≤ 3, the substance does not need to be classified for Eye irritation in accordance with the CLP Regulation.
Reference
- Summary of opacity, permeability and in vitro scores:
Treatment |
Mean Opacity |
Mean Permeability |
Mean in vitro Irritation Score |
Negative control |
0 |
0.000 |
0.0 |
Positive control |
99 |
2.673 |
139 |
L 130 |
0.3 |
0.004 |
0.4 |
- Individual in vitro irritancy scores:
Eye |
In vitro Irritancy Score |
Negative control |
|
1 |
2.1 |
2 |
-2.1 |
3 |
0.1 |
Positive control |
|
4 |
143.4 |
5 |
151.5 |
6 |
123.4 |
L 130 |
|
7 |
-0.9 |
8 |
1.0 |
9 |
1.1 |
No pH effect of the test substance was observed on the rinsing medium.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
As the acute dermal toxicity study did not indicate skin irritation up to the limit dose level (2000 mg/kg bw), the studies in vitro study for skin corrosion, in vitro study for skin irritation and in vivo study for skin irritation are not performed and is it concluded that the substance is not irritating/corrosive to the skin.
Eye irritation
Using the Bovine Corneal Opacity and Permeability test (BCOP test) the substance was screened for its eye irritancy potential in accordance with OECD 437 and according to GLP principles. The substance was applied as a 20% (w/w) suspension (750 µL) directly on top of the corneas. Adequate negative and positive controls were included. The substance did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 0.4 after 240 minutes of treatment.
Justification for selection of eye irritation endpoint:
One study available.
Justification for classification or non-classification
Based on the results of the performed acute dermal toxicity study the substance does not need to be classified for skin irritation, in accordance with the CLP Regulation, as no erythema nor oedema was observed during the observation period.
Based on the results of the performed BCOP test the substance does not need to be classified for Eye irritation, in accordance with the CLP Regulation, since the substance induced an IVIS ≤ 3.
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.
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