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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:
- From April 15 to May 20, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study performed according to OECD test guideline No. 405 and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- Adopted 09 October 2017
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- TBC_Inspected on / Signed on
Test material
- Reference substance name:
- (±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Cas Number:
- 1352216-65-9
- Molecular formula:
- C13H20O1
- IUPAC Name:
- (±)-1-[(1RS,2SR,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Reference substance name:
- (±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Cas Number:
- 1352216-63-7
- Molecular formula:
- C13H20O1
- IUPAC Name:
- (±)-1-[(1RS,2RS,4SR)-BICYCLO[2.2.1]HEPT-2-YL]-5-HEXEN-2-ONE
- Test material form:
- liquid
- Details on test material:
- Appearance: Colourless liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Storage: Fridge, light protected, under nitrogen.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source:
- Weight at study initiation: 2.52-2.73 kg
- Housing: Each animal was kept in an individual box installed in conventional air conditioned animal husbanding.
- Diet: foodstuff (SDS - C15), ad libitum
- Water: tap water from public distribution system, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 17-23 °C
- Humidity: 30-70 %
- Air changes: at least 10 cycles per hour.
- Photoperiod: 12 hours light/12 hours dark.
IN-LIFE DATES: From 15 April to 20 May 2019
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): Test item was instilled, as supplied - Duration of treatment / exposure:
- No washing was done
- Observation period (in vivo):
- Ocular examinations were performed on both right and left eyes 1, 24, 48 and 72 h & Days 7, 14 and 21 following treatment, according to a numerical evaluation.
- Number of animals or in vitro replicates:
- 3 males
- Details on study design:
- TREATMENT
- 0.1 mL of the test item was instilled, as supplied, into the conjunctival sac of one eye. The other eye remained untreated serving as control.
- Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
REMOVAL OF TEST SUBSTANCE
- Washing: No
SCORING SYSTEM: According to OECD guideline 405
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 day
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 1 day
- Irritant / corrosive response data:
- The ocular reactions observed during the study have been moderate and totally reversible:
- at the conjunctivae level: a moderate redness noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 2 and 14, associated with a moderate chemosis noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 1 and 7;
- at the iris level: an injection was noted 1 hour after the test item instillation in one animal and was totally reversible on Day 3;
- at the corneal level: a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 14 and 21. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Individual and Mean Scores for Cornea, Iris and Conjunctivae
Cornea | Iris | Conjunctivae | |||
Rabbit Number | Time after Treatment | Corneal Opacity | Iris Lesion | Conjunctival Redness | Conjunctival Chemosis |
Animal A7560 | 1h (D0) | 0 | 1 | 1 | 0 |
24h (D1) | 2 | 1 | 2 | 2 | |
48h (D2) | 2 | 1 | 2 | 2 | |
72h (D3) | 1 | 0 | 2 | 2 | |
Day 7 (D7) | 1 | 0 | 1 | 0 | |
Day 14 (D14) | 1 | 0 | 0 | 0 | |
Day 21 (D21) | 0 | 0 | 0 | 0 | |
Total (24, 48 and 72h) | 5 | 2 | 6 | 6 | |
Mean (24, 48 and 72h) | 1.7 | 0.7 | 2.0 | 2.0 | |
Rabbit Number | Time after Treatment | Corneal Opacity | Iris Lesion | Conjunctival Redness | Conjunctival Chemosis |
Animal A7584 | 1h (D0) | 0 | 0 | 2 | 2 |
24h (D1) | 2 | 0 | 1 | 0 | |
48h (D2) | 1 | 0 | 1 | 0 | |
72h (D3) | 1 | 0 | 0 | 0 | |
Day 7 (D7) | 1 | 0 | 0 | 0 | |
Day 14 (D14) | 0 | 0 | 0 | 0 | |
Day 21 (D21) | - | - | - | - | |
Total (24, 48 and 72h) | 4 | 0 | 2 | 0 | |
Mean (24, 48 and 72h) | 1.3 | 0.0 | 0.7 | 0.0 | |
Rabbit Number | Time after Treatment | Corneal Opacity | Iris Lesion | Conjunctival Redness | Conjunctival Chemosis |
Animal A7586 | 1h (D0) | 0 | 0 | 2 | 2 |
24h (D1) | 0 | 0 | 1 | 0 | |
48h (D2) | 0 | 0 | 0 | 0 | |
72h (D3) | 0 | 0 | 0 | 0 | |
Day 7 (D7) | - | - | - | - | |
Day 14 (D14) | - | - | - | - | |
Day 21 (D21) | - | - | - | - | |
Total (24, 48 and 72h) | 0 | 0 | 1 | 0 | |
Mean (24, 48 and 72h) | 0.0 | 0.0 | 0.3 | 0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the test conditions, the test material ST 03 C 18 is classified as irritating to eyes in Category 2 according to the Annex I of the Regulation EC No. 1272/2008 (CLP) and in Category 2A according to the GHS.
- Executive summary:
In an eye irritation study conducted according to OECD 405 guideline and in compliance with GLP, 3 New Zealand White male rabbits were exposed to 0.1 mL of test item in one eye while the contralateral eye remained untreated and served as control. The eyes were examined and the changes were observed at 1, 24, 48 and 72 h and Days 7, 14 and 21 following treatment and graded according to the Draize method. Initially, a single animal was treated. After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
The ocular reactions observed during the study have been moderate and totally reversible. At the conjunctivae level, a moderate redness noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 2 and 14, associated with a moderate chemosis noted 1 or 24 hours after the test item instillation in all animals and totally reversible between days 1 and 7. At the iris level, an injection was noted 1 hour after the test item instillation in one animal and was totally reversible on Day 3. At the corneal level, a moderate opacity, noted 24 hours after the test item instillation in two animals and totally reversible between days 14 and 21.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1.7, 1.0, 0.7 for cornea score; 0.3, 0.0, 0.0 for iris score; 1.7, 1.7, 1.0 for conjunctivae score and 1.3, 1.0, 1.3 for chemosis score.
Therefore, the test material, ST 03 C 18, is classified as irritanting to eyes in Category 2 according to the annex I of the Regulation EC No. 1272/2008 (CLP) and in Category 2A according to the GHS.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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