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EC number: 812-739-3 | CAS number: 157357-30-7
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From June 10 to June 25, 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP study conducted according to OECD test Guideline No. 405 with minor deviations that does not affect the reliability of the study: 6 animals tested instead of 3. The study was reliable and of good quality (Klimisch score = 2). The supporting substance is considered adequate for read-across purpose (see IUCLID section 13 for additional justification). Some environmental conditions were not reported but they were assumed to be adequate because iti s a GLP study.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- some details missing on test animals and environmental conditions but they were assumed to be adequate because it is a GLP study.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-pentylcyclopentan-1-ol
- EC Number:
- 283-187-3
- EC Name:
- 2-pentylcyclopentan-1-ol
- Cas Number:
- 84560-00-9
- IUPAC Name:
- 2-pentylcyclopentanol
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): ST 22 C 95
- Physical state: clear liquid
- Storage conditions: ambient temperature and humidity in the container in which it was received
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gingrich Animal Suply, Frdricksbury, PA. USDA # 23-B-007.
- Age at study initiation: no data.
- Weight at study initiation: no data.
- Housing: individually housed.
- Diet: Agway Prolab High Fiber Rabbit feed and Alfalfa cubes, ad libitum.
- Water: city water ad libitum.
- Acclimation period: at least 7 days.
ENVIRONMENTAL CONDITIONS
No data
IN-LIFE DATES: no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- Eyes were not rinsed after instillation
- Observation period (in vivo):
- Observations at 1, 24, 48, 72 and on days 4, 7 and 14 after exposure.
- Number of animals or in vitro replicates:
- 6 (Male and Female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
SCORING SYSTEM: according to OECD 405
TOOL USED TO ASSESS SCORE: evaluated by using the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances".
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal: #1, #2, #3 & #5
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #4
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- cornea opacity score
- Remarks:
- (opacity)
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #3, #5 & #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1 & #5
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #4
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1& #5
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal: #3 & #4
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #6
- Time point:
- other: mean 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Irritant / corrosive response data:
- The test material produced minimal conjunctival irritation (6/6) and chemosis (4/6) one hour post-instillation.
24 hours post instillation, corneal opacity in 6/6 animals and positive conjunctival irritation in 5/6 and positive chemosis in 3/6 animals. Iritis was observed in 1/6 animals on day 3 of the study.
On study day 7, there were no corneal opacities observed. Four animals had minimal conjunctival irritation. Three animals had minimal chemosis. No iritis was observed. All irritation cleared by day 14, therefore the study was terminated at that point. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Eye irritation response data for each animal at each observation time
Score at time point |
Cornea |
Iris (/2) |
Conjunctivae |
|||
Opacity (/4) |
Area (/4) |
Redness (/3) |
Chemosis (/4) |
Discharge (/3) |
||
24 h (Day 1) |
1 / 1 / 1 / 1 / 1 / 1 |
3 / 3 / 3 / 3 / 3 / 1 |
0 / 0 / 0 / 0 / 0 / 0 |
2 / 2 / 2 / 2 / 2 / 1 |
1 / 2 / 2 / 2 / 1 / 1 |
2 / 2 / 2 / 2 / 1 / 1 |
48 h (Day 2) |
1 / 1 / 1 / 1 / 1 / 0 |
1 / 3 / 2 / 2 / 1 / 0 |
0 / 0 / 0 / 0 / 0 / 0 |
1 / 3 / 2 / 3 / 1 / 1 |
1 / 3 / 2 / 2 / 1 / 0 |
1 / 3 / 2 / 2 / 1 / 1 |
72 h (Day 3) |
1 /1 / 1 / 0 / 1 / 0 |
1 / 3 / 1 / 0 / 1 / 0 |
0 / 0 / 0 / 1 / 0 / 0 |
1/ 3 / 2 / 2 / 1 / 1 |
1 / 3 / 2 / 2 / 1 / 0 |
1 / 3 / 2 / 2 / 1 / 0 |
Average 24h, 48h, and 72h |
1 / 1 / 1 / 0.67 / 1 / 0.33 |
1.67 / 3 / 2 / 1.67 / 1.67 / 0.33 |
0 / 0 / 0 / 0.33 / 0 / 0 |
1.33 / 2.67 / 2 / 2.33 / 1.33 / 1 |
1 / 2.67 / 2 / 2 / 1 / 0.33 |
1.33 / 2.67 / 2 / 2 / 1 / 0.67 |
Reversibility |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Completely reversible |
Average time (unit) for reversion |
7 days |
7 days |
4 days |
14 days |
14 days |
14 days |
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test material is classified as irritating to eyes (category 2) according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) based on 4/6 animals having a cornea score of 1 which fully reverses within 7 days.
- Executive summary:
In an eye irritation study performed according to the OECD guideline No. 405, 0.1 mL of undiluted test material was instilled into the eye of 6 New Zealand White Rabbit. The eyes were not rinsed after the instillation of the test item.The contralateral eye of each rabbit served as control. Animals were observed at 1, 24, 48 and 72 hours, and 4, 7 and 14 days after dosing. The reactions in the conjunctiva (redness, chemosis and discharge), the iris and the cornea (opacity and area involved) were scored according to the Draize scale.
The calculated mean score for each animal within 3 scoring times (24, 48 and 72 h) were 1.33 / 2.67 / 2 / 2.33 / 1.33 / 1 for redness, 1 / 2.67 / 2 / 2 / 1 / 0.33 for chemosis, 0 / 0 / 0 / 0.33 / 0 / 0 for iris lesions and 1 / 1 / 1 / 0.67 / 1 / 0.33 for corneal opacity. 4/ 6 rabbits show a mean score per animal ≥ 1 for corneal opacity. All the reactions were fully reversible within 14 days.
Under the test conditions, the test material is classified as irritating to eyes (category 2) according to the criteria of the Annex VI of the Regulation (EC) No 1272/2008 (CLP) based on 4/6 animals having a cornea score of 1 which fully reverses within 7 days.
This study is considered as acceptable and satisfies the requirement for eye irritation endpoint.
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