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EC number: 267-140-4 | CAS number: 67801-20-1
- 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 performed between 15 March 2010 and 25 March 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol
- EC Number:
- 267-140-4
- EC Name:
- 3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol
- Cas Number:
- 67801-20-1
- Molecular formula:
- C14H24O
- IUPAC Name:
- 3-methyl-5-(2,2,3-trimethylcyclopent-3-en-1-yl)pent-4-en-2-ol
- Reference substance name:
- Ebanol
- IUPAC Name:
- Ebanol
- Details on test material:
- Sponsor's identification: Ebanol
Description : pale yellow liquid
Batch number : VE00071661
Purity : ≥ 90.2% (GC analysis, sum of 3 peaks)
Date received : 29 January 2010
Expiry date : 10 June 2011
Storage conditions: room temperature in the dark
The integrity of supplied data relating to the identity, purity and stability of the test material is the responsibility of the Sponsor.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Animals and Animal Husbandry
Two New Zealand White rabbits were supplied by Harlan Laboratories U.K. Limited, Hillcrest, Belton, Loughborough, UK. At the start of the study the animals weighed 2.27 or 2.29 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five 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 (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, 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. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve 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.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- Preparation of Test Material
For the purpose of the study the test material was used as supplied.
The absorption of the test material was not determined.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test material 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 material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Appendix 1.
After consideration of the ocular responses produced in the first treated animal, a second animal was treated. - Duration of treatment / exposure:
- Up to 1 hour
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- Procedure
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 volume of 0.1 ml of the test material 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 material, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Appendix 1 - see section any other information on method.
After consideration of the ocular responses produced in the first treated animal, a second animal was treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in Appendix 2 (see section any other information on method), (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49).
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.
Individual bodyweights were recorded on Day 0 (the day of dosing) and at the end of the observation period.
Interpretation of Results
The numerical values corresponding to each animal, tissue and observation time were recorded. The data relating to the conjunctivae were designated by the letters A (redness), B (chemosis) and C (discharge), those relating to the iris designated by the letter D and those relating to the cornea by the letters E (degree of opacity) and F (area of cornea involved). For each tissue the score was calculated as follows:
Score for conjunctivae = (A + B + C) x 2
Score for iris = D x 5
Score for cornea = (E x F) x 5
Using the numerical data obtained a modified version of the system described by Kay J H and Calandra J C (1962), J. Soc. Cosmet. Chem. 13, 281 289 (see Appendix 3) was used to classify the ocular irritancy potential of the test material. This was achieved by adding together the scores for the cornea, iris and conjunctivae for each time point for each rabbit. The group means of the total scores for each observation were calculated. The highest of these group means (the maximum group mean score) together with the persistence of the reactions enabled classification of the eye irritancy potential of the test material.
If evidence of irreversible ocular damage is noted, the test material will be classified as corrosive to the eye.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 68973 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Highest score observed at 1 and 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: 69013 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Highest score observed at 1 and 48 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal: 68973 Male
- Time point:
- other: 1 , 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Highest score observed at 1 hour
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis score
- Basis:
- animal: 69013 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Highest score observed at 1 hour
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 68973 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 69013 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No effect noted
- Irritation parameter:
- iris score
- Basis:
- animal: 68973 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritation parameter:
- iris score
- Basis:
- animal: 69013 Male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effect noted
- Irritant / corrosive response data:
- Ocular Reactions
Individual and group mean scores for ocular irritation are given in Table 1 and Table 2 (in section any other information on results)
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one and 24 hours after treatment with minimal conjunctival irritation noted at the 48-Hour observation.
Both treated eyes appeared normal at the 72-Hour observation. - Other effects:
- None
Any other information on results incl. tables
Table 1 Individual Scores and Individual Total Scoresfor Ocular Irritation
Rabbit Number and Sex |
68973Male |
69013Male |
||||||
IPR= 2 |
IPR = 2 |
|||||||
Time After Treatment |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
CORNEA |
|
|
|
|
|
|
|
|
E = Degree of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
F = Area of Cornea Involved |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (E x F) x 5 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
IRIS |
|
|
|
|
|
|
|
|
D |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Score (D x 5) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
CONJUNCTIVAE |
|
|
|
|
|
|
|
|
A = Redness |
2 |
2 |
1 |
0 |
2 |
2 |
1 |
0 |
B = Chemosis |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
C = Discharge |
2 |
1 |
0 |
0 |
2 |
1 |
0 |
0 |
Score (A + B + C) x 2 |
12 |
8 |
2 |
0 |
12 |
8 |
2 |
0 |
Total Score |
12 |
8 |
2 |
0 |
12 |
8 |
2 |
0 |
IPR = Initial pain reaction
Table 2 Individual Total Scores and Group Mean Scoresfor Ocular Irritation
Rabbit Number and Sex |
Individual Total Scores At: |
|||
1 Hour |
24 Hours |
48 Hours |
72 Hours |
|
68973Male |
12 |
8 |
2 |
0 |
69013Male |
12 |
8 |
2 |
0 |
Group Total |
24 |
16 |
4 |
0 |
Group Mean Score |
12.0 |
8.0 |
2.0 |
0.0 |
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Criteria used for interpretation of results: other: modified Kay and Calandra classification system
- Conclusions:
- The neat (100%) test material was considered as a mild irritant to the rabbit eye.
- Executive summary:
Introduction.
The study was performed to assess the irritancy potential of the test material to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of CommissionRegulation (EC) No. 440/2008
Result.
A single application of the neat (100%) test material to the non-irrigated eye of two rabbits produced moderate conjunctival irritation. No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in both treated eyes one and 24 hours after treatment with minimal conjunctival irritation noted at the 48-Hour observation.
Both treated eyes appeared normal at the 72-Hour observation period.
The test material produced a maximum group mean score of 12.0 and was considered as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Conclusion.
The neat (100%) test material was considered as a mild irritant to the rabbit eye.
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