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EC number: 248-742-6 | CAS number: 27939-60-2
- 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:
- 16 June - 23 June 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was not continued until the total disappearance of the effects.
- Justification for type of information:
- The information is used for read across to Vertoliff.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: read-across information from an analogue is used
- Justification for type of information:
- The skin irritation of Vertoliff is based on read-across from Triplal. The full read-across document can be found in the Irritation Endpoint Summary in text and in the attached file.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean of all 4 animals from time points: 24, 48 and 72 hrs
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2.5
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Remarks:
- based on scoring
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean of all 4 animals from time points: 24, 48 and 72 hrs
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Remarks:
- based on scoring
- Interpretation of results:
- other: Skin irritant cat. 2
- Remarks:
- in accordance with EU CLP (EC No. 1272/2008 and its updates)
- Conclusions:
- Based on read across from Triplal, which is tested in a similar to OECD TG 404 study, Vertoliff is a skin irritant cat. 2.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- 2,4-dimethylcyclohex-3-ene-1-carbaldehyde
- EC Number:
- 268-264-1
- EC Name:
- 2,4-dimethylcyclohex-3-ene-1-carbaldehyde
- Cas Number:
- 68039-49-6
- Molecular formula:
- C9H14O
- IUPAC Name:
- 2,4-dimethylcyclohex-3-ene-1-carbaldehyde
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Healthy female rabbits were obtained from A. Smith Warlingham, Surrey. Animals were allowed an acclimatisation period of eighteen days. The rabbits were individually housed in grid bottomed metal cages. A commercially available antibiotic free rabbit diet (SQC standard rabbit pellets produced by Special Diet Services, Witham, Essex) and mains drinking water via automatic nozzles in each cage were available ad libitum. The rabbit holding room was air-conditioned with temperature in the range of 18-22°C and relative humidity in the range of 48-66% during the acclimatisation and study periods. Fluorescent lighting was controlled to give an artificial cycle of 12 hours light / 12 hours dark per day.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml of the test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 4
- Details on study design:
- The test material was applied on the back of animals. After removal of the adhesive tapes, the treated sites were cleansed by gentle swabbing with cotton wool soaked in warm water.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- mean of all 4 animals from time points: 24, 48 and 72 hrs
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2.5
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Remarks:
- based on scoring
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- mean of all 4 animals from time points: 24, 48 and 72 hrs
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- no indication of irritation
- Remarks:
- based on scoring
Any other information on results incl. tables
|
Erythema |
Oedema |
1 hour |
|
|
Rabbit 1 |
2 |
0 |
Rabbit 2 |
1 |
2 |
Rabbit 3 |
2 |
2 |
Rabbit 4 |
2 |
2 |
24 hours |
|
|
Rabbit 1 |
2 |
1 |
Rabbit 2 |
2 |
1 |
Rabbit 3 |
2 |
1.5 |
Rabbit 4 |
2 |
2 |
48 hours |
|
|
Rabbit 1 |
2 |
1 |
Rabbit 2 |
2 |
1.5 |
Rabbit 3 |
2 |
1 |
Rabbit 4 |
2 |
1.5 |
72 hours |
|
|
Rabbit 1 |
2 |
0.5 |
Rabbit 2 |
2.5 |
1 |
Rabbit 3 |
2 |
1 |
Rabbit 4 |
2 |
1 |
7 days |
|
|
Rabbit 1 |
1 |
0 |
Rabbit 2 |
1.5 |
0.5 |
Rabbit 3 |
1.5 |
0.5 |
Rabbit 4 |
2 |
0.5 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin irritant Cat. 2
- Remarks:
- in accordance with EU CLP (EC No. 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this study performed with rabbits similar to OECD 404, the scores obtained in test animals were not sufficient for classification. However, the effects did not disappear until the last taken observation (at day 7) and observations were not taken further, therefore there is no certainty that the effects would disappear completely. As a conservative approach, Triplal is classified as a skin irritant (category 2).
- Executive summary:
The skin irritation potential of Triplal was tested in vivo using 4 New Zealand White rabbits. Study was performed similar to OECD 404 with an observation period shorter than needed and therefore a Klimisch 2 rating was assigned. The test material was applied on the skin under a surgical patch, which was covered with elastic adhesive bandage. After an exposure period of 4 hours the patches were removed. The animals were observed at 24, 48 and 72 hours after patch removal and also later, until 7 days. The dermal effects observed at 24 hours after patch removal encompassed moderate erythema (all animals scored 2) and slight to moderate oedema (1 animal scored 2, 1 animal scored 1.5 and 2 animals scored 1). The dermal effects observed at 48 hours stayed at the same moderate erythema (all animals scored 2) and slight to moderate oedema (2 animals scored 1.5 and 2 animals scored 1). At 72 hours, oedema effects decreased (3 animals scored 1 and 1 animal scored 0.5), the erythema effects stayed at the same level (1 animal scored 2.5 and 3 animals scored 2). The last observation was made at 7 days and then there were still signs of both erythema (1 animal scored 2, 2 animals scored 1.5 and 1 animal scored 1) and oedema (3 animals scored 0.5 and 1 animal scored 0). Although the scores obtained in test animals at the time points 24/48/72 hrs were not sufficient for classification, the study was not continued until the complete disappearance of the effects (and the scores for erythema were still moderate). As a conservative approach, Triplal is classified as a skin irritant (category 2).
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