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EC number: 940-470-2 | 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:
- The study was conducted between 05 June 2015 and 16 June 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:
- (2S,4S,6S,8R)-4,7,8-trimethyltricyclo[5.2.1.0²,⁶]decan-8-ol; (2S,5S,6S,8R)-5,7,8-trimethyltricyclo[5.2.1.0²,⁶]decan-8-ol
- EC Number:
- 940-470-2
- Molecular formula:
- C13H22O
- IUPAC Name:
- (2S,4S,6S,8R)-4,7,8-trimethyltricyclo[5.2.1.0²,⁶]decan-8-ol; (2S,5S,6S,8R)-5,7,8-trimethyltricyclo[5.2.1.0²,⁶]decan-8-ol
- Test material form:
- other: Liquid
- Details on test material:
- Identification: FRET 08-0338
Chemical name: 4,7-Methano-1H-inden-5-ol, octahydro-3,4,5-trimethyl and 4,7-Methano-1H-inden-5-ol, octahydro-2,4,5-trimethyl and isomers
CAS number: 1340502-93-3 & 1340502-69-3
Intended use: Industrial fragrance
Description: Clear liquid
Storage conditions: Room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- The animal for this study was selected from a stock supply of healthy adult rabbits of the New Zealand White strain. The animal weighed 2.71 kg and was approximately 23 weeks of age, prior to treatment (Day 1). She had been acclimatised to the experimental environment for a period of approximately ten weeks prior to the start of the study.
The animal was housed individually in a plastic cage with perforated floors and was offered 150 g of a standard laboratory rabbit diet per day; drinking water was provided ad libitum.
The batch of diet used for the study is analysed for nutrients, possible contaminants and micro-organisms likely to be present in the diet and which, if in excess of specified amounts, might have an undesirable effect on the test system. A dietary supplement of hay was offered during acclimatisation until three days prior to dose instillation, for the remainder of acclimatisation and throughout the study observation period wholemeal bread was offered.
During the acclimatisation and study period the animal was given a small, soft white untreated wood block for environmental enrichment, replaced at appropriate intervals.
Results of routine physical and chemical examination of drinking water, as conducted by the supplier are made available to Huntingdon Life Sciences.
Animal room environmental controls were set to maintain temperature within the range 16 to 20°C, and relative humidity within 40 to 70%. These environmental parameters were recorded and the permanent record archived with other departmental raw data. Lighting was controlled by means of a time switch to give 12 hours of artificial light (06:00 to 18:00 GMT) in each 24 hour period.
The animal was identified by a numbered tag placed through the edge of one ear. This identification was unique within the Department throughout the duration of the study. The cage was identified by a coloured label displaying the study number and animal number.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The test substance was not removed
- Observation period (in vivo):
- Seven days after instillation
- Number of animals or in vitro replicates:
- One
- Details on study design:
- Treatment procedure
The eyes of the animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation. The animal was gently restrained and the dose was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The eyelids were then gently held together for one second before releasing; the left eye remained untreated.
A single animal was treated in advance; the presence of a severe effect in this animal prevented further animals being committed to the study.
Clinical signs
The behaviour of the rabbit was observed immediately following instillation of the test substance to allow assessment of the initial pain response.
The animal was returned to the cage and checked at least twice during the first hour after dosing and at regular intervals throughout the day to ensure no severe injury passed unnoticed. Ocular reactions to treatment were assessed 1, 24, 48 and 72 hours and seven days after treatment, according to the criteria below. Reactions not included overleaf were described in detail.
Ocular responses
The untreated eye was used as a comparison with the treated eye during assessment of ocular lesions.
A pencil beam torch was available for use to facilitate inspection of the eyes.
Termination
Following completion of the observation period the animal was humanely killed by an intravenous injection of sodium pentobarbital.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: Pannus formation (corneal neovascularisation) is considered to be an irreversible effect
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Irritant / corrosive response data:
- Ocular responses
A crimson-red conjunctival appearance was evident throughout the study period and very-slight or slight chemosis was apparent during the first 24 hours after instillation, with discharge evident at 1 hour after instillation only. Iritis was evident during the first 24 hours after instillation and also seven days later.
Scattered or diffuse areas of opacity covering up to the entire corneal surface were apparent throughout the first 72 hours after instillation. Seven days after instillation an easily discernible translucent area of opacity covering approximately one quarter of the corneal surface and an area of scattered or diffuse opacity covering approximately half the corneal surface were evident. In addition, two areas of pannus formation (corneal neovascularisation) were apparent; pannus formation is considered to be an irreversible effect and the animal was humanely killed immediately after this observation.
Instillation of the test material gave rise to no initial pain response. - Other effects:
- Clinical signs
There was no sign of toxicity or ill health in the study rabbit during the observation period.
Any other information on results incl. tables
Mean values for ocular lesions for Kay and Calandra classification
Mean irritation scores after instillation of FRET 08-0338
Area of eye |
1 hour |
24 hours |
48 hours |
72 hours |
7 days |
Cornea |
20 |
20 |
20 |
15 |
20 |
Iritis |
5 |
5 |
0 |
0 |
5 |
Conjunctiva |
12 |
6 |
4 |
4 |
4 |
Total mean score |
37 |
31 |
24 |
19 |
29 |
Mean values for ocular lesions for EC (Regulation 1272/2008) and GHS classification
24, 48 and 72 hours after instillation of FRET 08-0338
Animal number and sex |
Corneal opacity |
Iridial lesions |
Redness of conjunctiva |
Chemosis |
188 Female |
1.0 |
0.3 |
2.0 |
0.3 |
Grades for ocular irritation responses following instillation of FRET 08-0338
Animal number and sex: 188 F |
Pain evaluation response: 0 |
|||||
Region of the eye |
Response |
Grade of response at time after instillation |
||||
Hours |
Day |
|||||
1 |
24 |
48 |
72 |
7 |
||
Cornea |
Opacity (A) |
1 |
1F+ |
1F+ |
1F+ |
2F+AP |
Area (B) |
4 |
4 |
6 |
3 |
1 |
|
Ulceration |
- |
- |
- |
- |
- |
|
Stippling |
- |
- |
- |
- |
- |
|
Corneal score (A x B x 5) |
20 |
20 |
20 |
15 |
10 + 10 |
|
Iris |
Value (C) |
1 |
1 |
0 |
0 |
1 |
Iridial score(C x 5) |
5 |
5 |
0 |
0 |
5 |
|
Conjunctiva |
Redness (D) |
2 |
2 |
2 |
2 |
2 |
Chemosis (E) |
2 |
1 |
0 |
0 |
0 |
|
Discharge (F) |
2 |
0 |
0 |
0 |
0 |
|
Necrosis |
- |
- |
- |
- |
- |
|
Ulceration |
- |
- |
- |
- |
- |
|
Conjunctival score ((D + E + F) x 2) |
12 |
6 |
4 |
4 |
4 |
F = Female
F+ = Fluorescein positive
A = Additional area of opacity Grade 1 and Area 2 (fluorescein negative)
P = Two areas of pannus formation
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The highest total mean score was 37 occurring at the 1 hour observation; accordingly under the criteria Kay and Calandra (1962) FRET 08-0338 was classified as “moderately irritating” to the eye.
Pannus formation (corneal neovascularisation) is considered to be an irreversible effect; accordingly, FRET 08-0338 was classified as Category 1 in accordance with European Commission regulation 1272/2008. - Executive summary:
The eye irritation potential of the test substance (FRET 08-0338) was assessed according to OECD Test Guideline 405 using an in vivo method. Pannus formation (corneal neovascularisation) is considered to be an irreversible effect; accordingly, FRET 08-0338 was classified as Category 1 in accordance with European Commission regulation 1272/2008.
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