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Diss Factsheets
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EC number: 700-064-6 | CAS number: 2105830-60-0
- 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:
- June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test procedure according to validation study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HET-CAM Test
- Version / remarks:
- INVITTOX protocol 47 / The HET -CAM test - Method of Spielmann and Liebsch, January 1992.
- Principles of method if other than guideline:
- The aim of this study was to evaluate the ocular irritancy of the Substance as measured by its ability to induce adverse changes in the chorioallantoic membrane (CAM) of chicken eggs. The study procedures were based on the following documents and follow international recommendations
- The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM), Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Hen’s Egg Test - Chorioallantoic Membrane (HET-CAM) test method, March 2006.
- INVITTOX protocol 47. The HET-CAM test - Method of Spielmann and Liebsch, January 1992. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- EC Number:
- 700-064-6
- Cas Number:
- 2105830-60-0
- Molecular formula:
- Not applicable as this is a UVCB substance
- IUPAC Name:
- Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione
- Test material form:
- liquid
- Details on test material:
- - Molecular weight: 2800-3000
- CAS Name: Castor oil, polymer with tetrahydromethyl-1,3-isobenzofurandione
- Description: Very viscous amber liquid
- Test substance storage: At room temperature in the dark under nitrogen
- Stebility under storage conditions: Stable
- Expiry date: 01 January 2009
Constituent 1
Test animals / tissue source
- Species:
- chicken
- Strain:
- other: white leghorn
- Details on test animals or tissues and environmental conditions:
- Test System: Fresh, fertilised white leghorn chicken eggs weighing between 53 and 62 grams.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 300 mg test item
0.3 mL positive control (1% sodium dodecylphosphate prepared in physiological saline) and negative control (physiological saline) - Duration of treatment / exposure:
- 20 seconds
- Observation period (in vivo):
- 5 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The number of eggs used in the study was 3 per treatment group. On day 9 of incubation the air cells of the eggs were marked and cut off with a rotating saw blade. The uncovered inner membrane was moistened with physiological saline and subsequently the egg was kept at room temperature. Subsequently the physiological saline was removed and the inner egg membrane carefully eliminated using forceps to expose the CAM.
Three eggs were treated for 20 seconds with 300 mg of the Substance or with 0.3 mL of the negative or positive control solutions. After the treatment period the eggs were carefully rinsed with approximately 5 mL of physiological saline. The appearance of haemorrhage, vessel lysis and coagulation on the CAM was monitored and recorded over the following 280-second period.
Results from the three test method endpoints were evaluated separately for each egg. The irritancy score (IS) was calculated using the observed haemorrhage time, lysis time and coagulation time.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- HET-CAM
- Run / experiment:
- 20 sec treatement, 280 sec observation
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- score 0
- Positive controls validity:
- valid
- Remarks:
- score 14.7
- Other effects / acceptance of results:
- No other effects observed.
The mean in vitro irritancy score obtained with Ihe negative control was less than 1 indicating that the negative control did not induce irritancy on the chorioallantoic membrane.
The mean in vitro irritancy score of the positive control (1 % (wlv) Sodium dodecyl sulphate) was within the historical control data range. It was therefore concluded that the test conditions were adequate and that Ihe lest system functioned properly.
Any other information on results incl. tables
The results from the three test method endpoints and irritancy scores of the individual eggs.
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: ICCVAM and NICEATM
- Conclusions:
- It is concluded that this test is valid and that the substance is not irritant in the Hen’s Egg Test – Chorioallantoic Membrane Test under the experimental conditions described in this report.
- Executive summary:
The mean in vitro irritancy score obtained with the negative control was less than 1 indicating that the negative control did not induce irritancy on the chorioallantoic membrane. The mean in vitro irritancy score of the positive control (1% (w/v) Sodium dodecyl sulphate) was within the historical control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The mean in vitro irritancy score obtained during a 280-second observation period after 20 seconds treatment with the Substance was 0.
Finally, it is concluded that this test is valid and that the Substance is not irritant in the Hen’s Egg Test – Chorioallantoic Membrane Test under the experimental conditions described in this report.
This report describes the ocular irritation properties of the Substance on the chorioallantoic membrane of chicken eggs. The possible ocular irritancy of teh Substance was tested through topical application for 20 seconds.
The study procedures described in this report were based on recent HET-CAM documents.
The substance was a very viscous amber liquid. The test substance was applied undiluted (300 mg) directly on top of the chorioallantoic membrane.
The mean in vitro irritancy score obtained with the negative control was less than 1 indicating that the negative control did not induce irritancy on the chorioallantoic membrane. The mean in vitro irritancy score of the positive control (1% (w/v) Sodium dodecyl sulphate) was 14.7 and within the historical control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
The mean in vitro irritancy score obtained during a 280-second observation period after 20 seconds treatment with the Substance was 0.
Finally, it is concluded that this test is valid and that the Substance is not irritant in the Hen’s Egg Test – Chorioallantoic Membrane Test under the experimental conditions described in this report.
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