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EC number: 916-331-7 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-12-1976 - 24-01-1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Results are from an in vivo test conducted before the Reach regulation came into force requesting in vitro information.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Observations up to 72 hr, scoring system was not according to OECD-method
- GLP compliance:
- no
- Remarks:
- Pre-GLP
Test material
- Reference substance name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- EC Number:
- 916-331-7
- Molecular formula:
- C14H20O2
- IUPAC Name:
- Reaction mass of 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-5-yl isobutyrate and 3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-inden-6-yl isobutyrate
- Test material form:
- liquid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 - 12 weeks
ENVIRONMENTAL CONDITIONS
No information available
IN-LIFE DATES: No information available
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 100%
VEHICLE
Not applicable - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 10
- Details on study design:
- TEST SITE
- Area of exposure: Whole dorsal surface
- % coverage: no information available
- Type of wrap if used: Occlusive patches were prepared by heat-sealing 1"x1" 24 ply gauze pads on to 1.25"x1.25" squares of polythene sheeting which is then attached to 3.5"x1" strips of adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): after patch removal, treatment sites were wiped clean of excess material
- Time after start of exposure: 4 hours
SCORING SYSTEM: An 8-point anchored ordinate scale ranging from 'a' (very slight) to 'h' (severe) was used to score the treatment sites for erythema, oedema, cracking and scaling and any other feature:
Reaction grades and scores:
A: Marginal / very slight = 1
B: Slight = 2
C: Fairly distinct = 3
D: Quite distinct = 4
E: Becoming well developed = 6
F: Well developed = 8
G: Becoming severe = 10
H: Severe = 12
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- erythema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 1.66
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- no data
- Irritant / corrosive response data:
- Gardocyclene, as supplied, caused very slight to slight skin irritation in New Zealand White rabbits after 4 hours of semi-occlusive exposure.
Any other information on results incl. tables
Rabbit |
Total scores (4, 24, 48, 72 hours) |
Total score |
|||
Erythema |
Oedema |
Cracking |
Scaling |
||
2429 |
10 |
10 |
6 |
4 |
30 |
2431 |
9 |
7 |
11 |
10 |
37 |
2510 |
4 |
3 |
6 |
3 |
16 |
2513 |
7 |
3 |
4 |
2 |
16 |
2516 |
10 |
6 |
10 |
9 |
35 |
2469 |
8 |
3 |
4 |
3 |
18 |
2504 |
5 |
4 |
7 |
6 |
24 |
2499 |
11 |
5 |
8 |
6 |
30 |
Overall Irritation Score |
206.00 |
||||
Mean score per site |
25.75 |
||||
Mean score per site per day |
6.44 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a skin irritant
- Remarks:
- according to EU CLP (1272/2008/EC and its updates.
- Conclusions:
- In a skin irritation study in rabbits which was performed according to a method which is equivalent to OECD 404, Cyclabute is not a skin irritant.
- Executive summary:
The ability of Cyclabute to induce skin irritation in rabbits was investigated in a skin irritation study which was performed according to a method which is equivalent to OECD404 (pre-GLP). The test material was applied to the clipped dorsum skin for 4 hours under a semi-occlusive dressing. After removal of the patches, the treatment sites were wiped clean of excess material and examined for evidence of irritation. Further assessemnts were made at 24, 48 and 72 hours after treatment. Cyclabute caused very slight to slight skin irrtiation. The scores indicate absence of irritation.
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