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EC number: 452-280-2 | 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:
- 13 Feb 2004 to 1 Apr 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- conducted under GLP conditions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- (E)-3-methylcyclotetradec-5-en-1-one
- Cas Number:
- 259854-70-1
- Molecular formula:
- C15H26O
- IUPAC Name:
- (E)-3-methylcyclotetradec-5-en-1-one
- Reference substance name:
- (Z)-3-methylcyclotetradec-5-en-1-one
- Cas Number:
- 259854-71-2
- Molecular formula:
- C15H26O
- IUPAC Name:
- (Z)-3-methylcyclotetradec-5-en-1-one
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Identification: KARMALONE
Description: Colourless to pale yellow liquid
Batch number: TOT0300497
Purity: 90.9%
Stability of test item: Stable under storage conditions
Expiry date: 28-NOV-2004
Storage conditions: At room temperature (range of 20 ± 3 °C), light protected.
Safety precautions: Routine hygienic procedures were used to ensure the health and satety of the personnel.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: Elevage scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
Number of animals per test : 3 (animals of both sexes were used)
Age at treatment: 11-12 weeks (male) and 12-13 weeks (females)
Identification: By unique cage number and corresponding ear number
Acclimatization: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
Allocation: Male No. 16 and Females Nos 17 and 18
Room number: 106 / RCC Ltd, Fullinsdorf
Conditions:
Standard Laboratory Conditions
Air-conditioned with target ranges for room temperature 17-23 °C, relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these ranges may have occasionally occurred, usually following room cleaning. These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the daytime light period.
Accommodation: Individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Fullinsdorf) and haysticks 4646 (batch no. 0403, Provimi Kliba AG) were provided for gnawing.
Diet: Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 86/03) provided by Provimi Kliba AG, CH-4303 Kaiseraugst. Results of analysis for contami nants are archived at RCC Ltd, ltingen.
Water: Community tap water from Fullinsdorf, ad libitum. Results of bacteriological, chemical and contaminant analyses are ar chived at RCC Ltd, ltingen.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL of the test material undiluted
- Duration of treatment / exposure:
- On the day of treatment, 0.1 ml of KARMAlONE was placed in the conjunctiva! sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
- Observation period (in vivo):
- The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after instillation.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Treatment: The eyes of the animals were examined one day prior to test item administration.
Animals with overt signs of ocular injury or irritation which may have interfered with the interpretation of the results were not used in the test.
On the day of treatment, 0.1 ml of KARMAlONE was placed in the conjunctiva! sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second to prevent loss of test item. The right eye remained untreated and served as the reference control. The treated eyes were not rinsed after instillation.
As it was suspected that the test item might produce irritancy, a single animal (one female) was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1- and 24-hour examinations, the test was completed using the two remaining animals.
Observations
Viability/Mortality: Daily from acclimatization of the animals to the termination of test.
Clinical signs: Daily from acclimatization of the animals to the termination of test.
Body weights: At start of acclimatization, on the day of application and at termination of observation.
Irritation scores
The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after instillation.
When present, corrosion and/or staining of conjunctivae, sclerae and cornea by the test item were recorded and reported.
Treatment of results:
Data are summarized in tabular form, showing the irritation scores of each following parameters: corneal opacity (including the area affected, where applicable), iridic effects, chemosis, conjunctiva! and scleral reddening for each individual animal at all observation intervals. In addition, any lesions including the degree and nature of irritation, corrosion or reversibility, and any other toxic effects are presented.
To evaluate the irritation potential of the test item mean values were calculated for each individual animal. Mean Values represent the mean of all available numerical scores (with the exception of the sclerae) recorded for the same parameter in each animal at 24, 48 and 72 hours.
For EU Classification of ocular irritants (Commission Directive 2001/59/EC), the criteria from the Official Journal of the European Communities (O.J. L 225/1) was employed (see page 23).
Necropsy: No necropsy was performed on the animals sacrificed at termination of observation.
All rabbits were sacrificed by an intravenous injection of Vetanarcol into the ear vein at a dose of at least 1 mUkg body weight (equivalent to 162 mg sodium pentobarbitone/kg body weight) and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 16
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 17 and 18
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and
0.33 for reddening and 0.00 for chemosis in all three animals, respectively.
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals.
Moderate reddening of the conjunctivae, slight to moderate swelling, slight ocular discharge and moderate reddening of the sclerae were observed in all three animals at the 1-hour reading. The reddening of the conjunctivae faded to grade 1 (slightly reddened) in the two females at the 24-hour examination.
No abnormal findings were observed in the treated eye of any animal 48 hours after treatment. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining of the treated eyes produced by the test item was observed.
No corrosion of the cornea was observed at any of the reading times.
The body weights of all rabbits were considered to be within the normal range of variability.
Any other information on results incl. tables
Bodv weioht in orams |
||||
AnimalNo. |
Sex |
First Day of Acclimatization |
Day ofTreatment |
Last Day of Observation |
16 |
male |
2099 |
2258 |
2331 |
17 |
female |
2040 |
2201 |
2263 |
18 |
female |
2096 |
2265 |
2356 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), KARMALONE is considered to be "not irritating" to the rabbit eye.
- Executive summary:
The primary eye irritation potential of KARMALONE was investigated according to OECD test guideline no. 405. The test item was applied by instillation of 0.1 ml into the left eye of each of three young adult New Zealand White rabbits. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after test iteminstillation.
The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and
0.33 for reddening and 0.00 for chemosis in all three animals, respectively.
The instillation of KARMALONE into the eye resulted in slight to moderate, early-onset and transient ocular changes, such as reddening of the conjunctivae and sclerae, discharge and chemosis. These effects were reversible and were no longer evident 48 hours after treatment. No abnormal findings were observed in the cornea or iris of any animal at any of the examinations. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed and no other clinical signs of test item related effects wereobserved.
Thus, the test item did not induce significant or irreversible damage to the rabbit eye.
Based upon the referred classification criteria (Commission Directive 2001/59/EC of August 06, 2001), KARMALONE is considered to be "not irritating" to the rabbiteye.
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