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EC number: 940-300-7 | CAS number: 1339119-15-1
- 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:
- The study was conducted between 02 March 2015 and 06 April 2015.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is considered to be a reliability 1 as it has been conducted according to OECD Test Guideline 405 using an in vivo method and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-[(8R)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde; 2-[(8S)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde
- EC Number:
- 940-300-7
- Cas Number:
- 1339119-15-1
- Molecular formula:
- C12H18O
- IUPAC Name:
- 2-[(8R)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde; 2-[(8S)-tricyclo[5.2.1.0²,⁶]decan-8-yl]acetaldehyde
- Test material form:
- other: Liquid
- Details on test material:
- Identification (trade name): IFF TM 11-213 (FRET 09-0425)
Chemical (IUPAC) name of multi constituent: Reaction mass of 4,7-Methano-1H-indene-5-acetaldehyde, octahydro- and 4,7-Methano-1H-indene-5-carboxaldehyde, octahydro-6-methyl-
IPC number: 134635
Physical state / Appearance: clear colorless liquid
Storage Conditions: approximately 4 °C in the dark under nitrogen
Constituent 1
IUPAC names of constituents: 4,7-Methano-1H-indene-5-acetaldehyde, octahydro-
CAS number: 1339119-15-1
Concentration of tested sample: 92.6%
Concentration range: 90-100%
Molecular formula: C12H18O
Molecular weight: 178.28
Constituent 2
IUPAC names of constituents: 4,7-Methano-1H-indene-5-carboxaldehyde, octahydro-6-methyl-
CAS number: 1338815-87-4
Concentration of tested sample: 5.7%
Concentration range: 5-15%
Molecular formula: C12H18O
Molecular weight: 178.28
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories UK Ltd., Leicestershire, UK. At the start of the study the animals weighed 2.93 to 3.22 kg and were 12 to 20 weeks old. After an acclimatization period of at least 5 days each animal was given a number unique within the study which was written with a black indelible marker pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930C Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23 °C and 30 to 70% respectively. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Justification
The rabbit is the preferred species of choice as historically used for irritation studies and is specified in the appropriate test guidelines.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The left eye remained untreated and was used for control purposes
- Amount / concentration applied:
- 0.1 mL of the test item
- Duration of treatment / exposure:
- The test item was not removed
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- Three
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A subcutaneous injection of buprenorphine 0.01 mg/kg was administered 60 minutes prior to test item application to provide a therapeutic level of systemic analgesia. Five minutes prior to test item application, a pre dose anesthesia of ocular anesthetic (two drops of 0.5% tetracaine hydrochloride) was applied to each eye.
A volume of 0.1 mL of the test item was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made.
Eight hours after test item application, a subcutaneous injection of post dose analgesia, buprenorphine 0.01 mg/kg and meloxicam 0.5 mg/kg, was administered to provide a continued therapeutic level of systemic analgesia. The treated animal was checked for signs of pain and suffering approximately 12 hours later. No further analgesia was required.
After consideration of the ocular responses produced in the first treated animal, two additional animals were similarly treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation.
Any other ocular effects were also noted. Examination of the eye was facilitated by the use of the light source from a standard ophthalmoscope.
Any clinical signs of toxicity, if present, were also recorded.
Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects.
Individual body weights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- iris score
- Remarks:
- Male 74958
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Remarks:
- Male 75009
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Remarks:
- Male 75010
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Male 74958
- Basis:
- mean
- Remarks:
- Redness
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Male 75009
- Basis:
- mean
- Remarks:
- Redness
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- Male 75010
- Basis:
- mean
- Remarks:
- Redness
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- Male 74958
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- chemosis score
- Remarks:
- Male 75009
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Remarks:
- Male 75010
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- Red colored staining of the fur around the treated eye was noted in one animal 1 hour after treatment.
No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes 1 and 24 hours after treatment and in one treated eye at the 48 Hour observation.
Moderate conjunctival irritation was noted in all treated eyes 1 hour after treatment and at the 24, 48 and 72 Hour observations. Minimal conjunctival irritation was noted in one treated eye at the 7 and 14 Day observations.
Two treated eyes appeared normal at the 7 Day observation and one treated eye appeared normal at the 21 Day observation. - Other effects:
- Body Weight
All animals showed expected gain in body weight during the study.
Any other information on results incl. tables
Individual Scores and Individual Total Scores for Ocular Irritation
Rabbit Number and Sex |
74958Male |
75009Male |
75010Male |
||||||||||||||
IPR= 0 |
IPR = 0 |
IPR = 0 |
|||||||||||||||
Time After Treatment |
1 |
24 |
48 |
72 |
7 |
14 |
21 |
1 |
24 |
48 |
72 |
7 |
1 |
24 |
48 |
72 |
7 |
CORNEA |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
D |
1 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
Score (D x 5) |
5 |
5 |
0 |
0 |
0 |
0 |
0 |
5 |
5 |
0 |
0 |
0 |
5 |
5 |
5 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A = Redness |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
0 |
B = Chemosis |
2 |
2 |
2 |
2 |
1 |
1 |
0 |
2 |
2 |
2 |
2 |
0 |
2 |
2 |
2 |
2 |
0 |
C = Discharge |
2Sf |
2 |
1 |
1 |
0 |
0 |
0 |
2 |
2 |
2 |
1 |
0 |
2 |
2 |
2 |
1 |
0 |
Score (A + B + C) x 2 |
12 |
12 |
10 |
10 |
4 |
4 |
0 |
12 |
12 |
12 |
10 |
0 |
12 |
12 |
12 |
10 |
0 |
Total Score |
17 |
17 |
10 |
10 |
4 |
4 |
0 |
17 |
17 |
12 |
10 |
0 |
17 |
17 |
17 |
10 |
0 |
IPR= Initial pain reaction
Hr = Hour
Dy = Days
Sf = Red colored staining of the fur around the treated eye
Individual Total Scores and Group Mean Scores for Ocular Irritation
Rabbit Number |
Individual Total Scores At: |
||||||||||||||
1 |
24 |
48 |
72 |
7 |
14 |
21 |
|||||||||
74958Male |
17 |
17 |
10 |
10 |
4 |
4 |
0 |
||||||||
75009Male |
17 |
17 |
12 |
10 |
0 |
- |
- |
||||||||
75010Male |
17 |
17 |
17 |
10 |
0 |
- |
- |
||||||||
Group Total |
51 |
51 |
39 |
30 |
4 |
4 |
0 |
||||||||
Group Mean Score |
17.0 |
17.0 |
13.0 |
10.0 |
1.3 |
1.3 |
0.0 |
- = Observation not required - considered to be zero for calculation of Group Mean Score
Individual Body Weights and Body Weight Change
Rabbit Number |
Individual Body Weight (kg) |
Body Weight Change (kg) |
|
74958Male |
Day 0 |
Day 21 |
0.15 |
2.99 |
3.14 |
||
75009Male |
Day 0 |
Day 7 |
0.08 |
3.22 |
3.30 |
||
75010Male |
Day 0 |
Day 7 |
0.17 |
2.93 |
3.10 |
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item produced a maximum group mean score of 17.0 and was classified as a moderate irritant (Class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test item was classified as Category 2A (irritating to eyes) according to the Globally Harmonized System of Classification and Labelling of Chemicals.
The test item was also classified as Irritating to eyes (Category 2) according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. It is reasonable to assume that the Signal Word “Warning” and the Hazard Statement “H319: Causes serious eye irritation” are therefore required. - Executive summary:
The eye irritation potential of the test substance, TM 11-213, was assessed according to OECD Test Guideline 405 using an in vivo method as classified - Category 2 (irritating to eyes).
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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