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EC number: 401-620-8 | CAS number: 87731-18-8 VIOLIFF
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April/ May 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- See below
- Principles of method if other than guideline:
- Various deviations from the guideline: Limited details on test material; Resting period between induction and challenge is 3 weeks instead of recommended 10-14 days; Contact of test substance with skin 6 hours instead of recommended 48 hours during induction and challenge; Choice of vehicle not justified (same vehicle chosen in induction and in challenge phase); No re-challenge was done. Purity and batch number of test substance not indicated.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA is not performed because other reliable information is available.
Test material
- Reference substance name:
- Methoxycarbonyloxycyclooct-4-ene
- EC Number:
- 401-620-8
- EC Name:
- Methoxycarbonyloxycyclooct-4-ene
- Cas Number:
- 87731-18-8
- Molecular formula:
- C10H16O3
- IUPAC Name:
- (1R,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (1S,3aS,6aS)-octahydropentalen-1-yl methyl carbonate; (3Z)-cyclooct-3-en-1-yl methyl carbonate; (4Z)-cyclooct-4-en-1-yl methyl carbonate; bicyclo[3.2.1]octan-8-yl methyl carbonate
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Douglasville, Pennsylvania
- Weight at study initiation: 300 - 500 gram
- Housing: two per cage in wire mesh cages
- Diet: Wayne Guinea Pig Diet, ad libitum
- Water: fresh tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: April 23, 1985 To: May 22, 1985
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/distilled water (4/1)
- Concentration / amount:
- 3%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/distilled water (4/1)
- Concentration / amount:
- 3%
- No. of animals per dose:
- Test substance: 20 (10 male and 10 female)
- Details on study design:
- RANGE FINDING TESTS:
Eight unexposed animals (4 males and 4 females) were exposed to eight concentrations of the test material (0,5%; 1%; 2%; 4%;10%; 25%; 50%; 100%) by the same technique as used for induction exposure. In this test, both sides of the animal were shaved and exposed to eight concentrations of the material. Only 24 hour grades were obtained.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: Test substance
- Control group: Solvent control and positive control
- Site: Left shoulder; 5x10 cm (appr. 10% of the body surface)
- Frequency of applications: weekly
- Concentrations: Test substance (3%), positive control (0.3%); 0.4 ml/ site
- Site was occluded with Parke-Davis Readi-bandage (R)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 13 days after last induction
- Exposure period: 6 hours
- Test groups: Test substance,
- Control group: Solvent control, positive control and naive control
- Site: naive site on left side
- Concentrations: 1%
- Evaluation (hr after challenge): 24 and 48
- Site was occluded with Parke-Davis Readi-bandage (R) - Challenge controls:
- Solvent control: 10 (5 male and 5 female)
Positive control: 5 (3 males and 2 females)
Naive control (challenge only): 4 (2 males and 2 females) - Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-dinitrobenzene (DNCB) at 0.3%
Results and discussion
- Positive control results:
- A positive response was elicited in all animals receiving the positive control article.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 19
- Clinical observations:
- slightly patchy erythema (7 animals); slight or confluent or moderate patchy erythema (3 animals)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 19
- Clinical observations:
- slightly patchy erythema (7 animals); slight or confluent or moderate patchy erythema (1 animal)
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- solvent only
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- slightly patchy erythema
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.3%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Clinical observations:
- moderate erythema (1 animal); severe erythema with/without edema (4 animals)
- Reading:
- other: 1st and 2nd reading
- Hours after challenge:
- 24
- Group:
- other: naive
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- none
Any other information on results incl. tables
One animal (f) treated with the test substance died during the course of the study. Necropsy of this animal revealed: hydrothorax, ascites, enlarged spleen and a fluid-filled pericardial sac. The death was determined to be non-compound related.
Number of animals/ dermal Irritation scores at 48 hours after 3rd induction:
Score | Test substance (3%) | Pos. control (0.3%) |
no reaction | 4 | 0 |
slightly patchy erythema | 3 | 0 |
slight or confluent or moderate patchy erythema | 2 | 0 |
moderate erythema | 5 | 0 |
severe erythema with/without edema | 6 | 5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: The substance is a skin sensitiser 1B in accordance with EU CLP (1272/2008 and its amendments)
- Conclusions:
- The substance is a skin sensitiser (1B) in the Buehler test (OECD guideline 406).
- Executive summary:
The substance was tested in a Buehler test (OECD TG 406) at a concentration of 3% in the topical induction phase based on the irritancy seen at higher concentrations during a range-finding test. The concentration for the challenge phase was 1%. At the first reading (24 h after the challenge) slightly patchy erythema was observed in 7 animals and slight or confluent or moderate patchy erythema was observed in 3 animals. At the second reading (48 h after the challenge) slightly patchy erythema was observed in 7 animals and slight or confluent or moderate patchy erythema was observed in 1 animal. The clinical observations resulted in a 15.7% sensitised animals which exceeds the threshold of 15%. Based on these results, the substance is a skin sensitiser (1B).
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