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EC number: 204-472-0 | CAS number: 121-46-0
- 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:
- September 2017 - January 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 8,9,10-trinorborna-2,5-diene
- EC Number:
- 204-472-0
- EC Name:
- 8,9,10-trinorborna-2,5-diene
- Cas Number:
- 121-46-0
- Molecular formula:
- C7H8
- IUPAC Name:
- bicyclo[2.2.1]hepta-2,5-diene
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- batch number of test material: N° ELI 70700450
- Production date: 31 August 2017
- Expiry date February 2018
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability and homogeneity of the test material under test conditions and during storage: stable
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source:
Eyes collected from chickens obtained from a slaughterhouse (Etablissement Brun, 33820 Etauliers, France)
- Characteristics of donor animals:
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, I .5 - 2.5 kg).
- Storage, temperature and transport conditions of ocular tissue:
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 04 December 2017 at 10:20 am.
- Time interval prior to initiating testing:
Immediately following the zero reference measurements, the eye (in its holder) was removed from the superfusion apparatus, placed in a horizontal position, and 30 µL of the test item was applied, as supplied, to the cornea such that the entire surface of the cornea was evenly covered with the test item.
- Indication of any existing defects or lesions in ocular tissue samples:
None
- Selection and preparation of corneas:
The eyelids were carefully excised, taking care not to damage the cornea. Then, the eye was further dissected from the skull, taking care not to damage the cornea. The eyeball was pulled from the orbit by holding the nictitating membrane firmly with surgical forceps, and the eye muscles were cut with a bent, blunt-tipped scissor. When the eye is removed from the orbit, a visible portion of the optic nerve should be left attached. Once removed from the orbit, the eye was placed on an absorbent pad and the nictitating membrane and other connective tissue were cut away.
The enucleated eye was mounted in a stainless steel clamp with the cornea positioned vertically. The clamp was then transferred to a chamber of the superfusion apparatus. The clamps were positioned in the superfusion apparatus such that the entire cornea was supplied with the physiological saline drip (in the range 0.1 to 0.15 mL/min). The chambers of the superfusion apparatus was temperature controlled between 31.7°C and 32.4°C
Once all eyes had been examined and approved, the eyes were incubated between 45 and 64 minutes to equilibrate them to the test system prior to dosing. Following the equilibration period, a zero reference measurement was recorded for corneal thickness and opacity to serve as a baseline (i.e., time = 0). The fluorescein score determined at dissection was used as the baseline measurement for that endpoint.
- Quality check of the isolated corneas:
After being placed in the superfusion apparatus, the eyes were examined with a slit-lamp microscope to ensure that they have not been damaged during the dissection procedure. Corneal thickness was also measured at this time at the corneal apex using the depth measuring device on the slit-lamp microscope. Eyes with; (i), a fluorescein retention score of > 0.5; (ii) corneal opacity > 0.5; or, (iii), any additional signs of damage were replaced. For eyes that are not rejected based on any of these criteria, individual eyes with a corneal thickness deviating more than 10% from the mean value for all eyes are to be rejected.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 30 µL
- Duration of treatment / exposure:
- 10s
- Duration of post- treatment incubation (in vitro):
- 30, 75, 120, 180, and 240 minutes (± 5 minutes) after the post-treatment rinse
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 3
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- Mean
- Value:
- 3
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- corneal swelling
- Run / experiment:
- Mean
- Value:
- 17
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Endpoint measured | Eye No | Time (min) | |||||
0 | 30 | 75 | 120 | 180 | 240 | ||
Corneal opacity | 7 | 0 | 3 | 3 | 3 | 3 | 3 |
8 | 0 | 3 | 3 | 3 | 3 | 3 | |
9 | 0 | 3 | 3 | 3 | 3 | 3 | |
Mean | 0.0 | 3.0 | 3.0 | 3.0 | 3.0 | 3.0 | |
ICE class | IV | ||||||
Fluorescein retention | 7 | 0.5 | 3 | - | - | - | - |
8 | 0.5 | 3 | - | - | - | - | |
9 | 0.5 | 3 | - | - | - | - | |
Mean | 0.5 | 3.0 | - | - | - | - | |
ICE class | IV | ||||||
Corneal thickness | 7 | 0.58 | 0.61 | 0.64 | 0.65 | 0.66 | 0.67 |
8 | 0.60 | 0.63 | 0.66 | 0.67 | 0.69 | 0.70 | |
9 | 0.57 | 0.60 | 0.63 | 0.64 | 0.67 | 0.67 | |
Corneal swelling | 7 | - | 5 | 10 | 12 | 14 | 16 |
8 | - | 5 | 10 | 12 | 15 | 17 | |
9 | - | 5 | 11 | 12 | 18 | 18 | |
Mean | - | 5 | 10 | 12 | 15 | 17 | |
ICE class | II | ||||||
Combination of the 3 Endpoints | 2 x IV, 1 x II | ||||||
Classification | Category 1 : Corrosive / Severe irritant |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- In accordance with the Regulation (EC) No. 1272/2008, the test item has to be classified in Category 1 "Irreversible effects on the eye"
The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are required. - Executive summary:
The aim of the study was to evaluate the possible ocular corrosive or severe imitating 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 26 July 2013 and the test method B.48 — Commission Regulation (EU) No. 1152/2010 dated 08 December 2010 (EU Journal L324) - ATP Council regulation No. 440/2008 of 30 May 2008 (E. U. Journal L142).
The ocular reactions observed in eyes treated with the test item were:
- maximal mean score of corneal opacity: 3.0, corresponding to ICE class IV;
- mean score of fluorescein retention: 3.0, corresponding to ICE class IV;
- maximal mean corneal swelling: 17%, corresponding to ICE class II.
The combination of the three endpoints for the test item was 2 x IV, 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 test item has to be classified in Category 1 "Irreversible effects on the eye".
The signal word "Danger" and hazard statement H318 "Causes serious eye damage" are required.
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