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EC number: 269-522-6 | CAS number: 68259-31-4
- 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:
- 2000-04-04 to 2000-04-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 8-isopropyl-6-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- EC Number:
- 267-308-7
- EC Name:
- 8-isopropyl-6-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Cas Number:
- 67845-30-1
- Molecular formula:
- C13H20O
- IUPAC Name:
- 8-isopropyl-6-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Reference substance name:
- 7-isopropyl-5-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- EC Number:
- 299-795-7
- EC Name:
- 7-isopropyl-5-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Cas Number:
- 93904-56-4
- Molecular formula:
- C13H20O
- IUPAC Name:
- 7-isopropyl-5-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Reference substance name:
- rel-(1S,2R,4R)-1-isopropyl-4-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Cas Number:
- 36208-34-1
- Molecular formula:
- C13H20O
- IUPAC Name:
- rel-(1S,2R,4R)-1-isopropyl-4-methylbicyclo[2.2.2]oct-5-ene-2-carbaldehyde
- Test material form:
- liquid
Constituent 1
Constituent 2
impurity 1
- Specific details on test material used for the study:
- Identification: Lierral
Description: colourless to pale yellow liquid
Batch Number: 9000365675
Purity: 99.5%
Stability of test article: Stable under storage conditions; expiration date: 20-Dec-2000
Storage conditions: In the original container, at room temperature (range of 20 +/- 3 °C), away from direct sunlight
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 16 weeks (male) and 14 weeks (females)
- Weight at study initiation: 2.7 to 3.1 kg
- Housing: Animals were housed individually in stainless steel cages, with autoclaved wood and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water ad libitum in drinking water bowls
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 - 70 % (relative)
- Air changes (per hr): 10 - 15 air changes per hour
- Photoperiod (hrs dark / hrs light): An automatically controlled light cycle of 12 hours light and 12 hours dark. Music was played during the light cycle.
IN-LIFE DATES: From: 2000-04-04 To: 2000-04-25
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Four days before treatment, the left flank was clipped with an electric clipper, exposing an area of approximately 100 cm² (10 x 10 cm). The skin of the animals was examined one day before treatment, and regrown fur of all animals was again clipped. The test material was put on a surgical gauze patch (ca. 2.5 x 2.5 cm). This gauze patch was applied to approximately 6 cm² of the intact skin of the clipped area.
- Type of wrap if used: The patch was covered with a semi-occlusive dressing. The dressing was wrapped around the abdomen and anchored with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): When the dressing was removed, the skin was flushed with lukewarm tap water to clean the application site so that any reactions (erythema) were clearly visible at that time.
- Time after start of exposure: 4 hours
SCORING SYSTEM: The skin reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31 1992 (shown below) at approximately 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after the removal of the dressing, gauze patch and test material.
ERYTHEMA AND ESCHAR FORMATION
0 = No erythema
1 = Very slight erythema
2 = Well-defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beet redness) or eschar formation (injuries in depth preventing erythema) reading
OEDEMA FORMATION
0 = No oedema
1 = Very slight oedema (barely perceptible)
2 = Slight oedema (edges of area well-defined by definite raising)
3 = Moderate oedema (edges raised approximately 1 mm)
4 = Severe oedema (raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean score at 24, 48 and 72 hours
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean score at 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean score at 24, 48 and 72 hours
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- other: mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No oedema was seen at any time point in any animal
- Irritant / corrosive response data:
- Very slight to well-defined erythema was observed in all animals at the 1 hour observation which persisted until the 48 hour reading (one animal) or diminished at day 7 (one animal) or day 14 (one animal). No oedema was observed within the 14 days after treatment. Slight to moderate scaling appeared at the 7 day reading in all animals and disappeared at the 14 day reading.
All skin reactions were clear within 14 days after treatment.
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin. - Other effects:
- No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining by the test material of the treated skin was observed.
Any other information on results incl. tables
Table 1: Skin Irritation Scores - Individual Values
Animal Number |
Sex |
Evaluation Interval |
Erythema |
Oedema |
1 2 3 |
M F F |
1 hour |
1 2 2 |
0 0 0 |
1 2 3 |
M F F |
24 hours |
1 2 2 |
0 0 0 |
1 2 3 |
M F F |
48 hours |
1 2 2 |
0 0 0 |
1 2 3 |
M F F |
72 hours |
0 2 1 |
0 0 0 |
1 2 3 |
M F F |
7 days |
0 1 0 |
0 0 0 |
1 2 3 |
M F F |
10 days |
0 1 0 |
0 0 0 |
1 2 3 |
M F F |
14 days |
0 0 0 |
0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study, the test material was found to be not irritating to the skin of New Zealand White rabbits.
- Executive summary:
The skin irritation potential of the test material was investigated in a study which was conducted under GLP conditions and in accordance with the standardised guidelines OECD 404 and EU Method B.4.
The primary skin irritation potential was investigated by topical semi-occlusive application of 0.5 mL of the test material to the clipped left flank of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing. The scores of each animal at the 24, 48 and 72 hour time points were used in calculating the mean values for each type of lesion.
Very slight to well-defined erythema was observed in all animals at the 1 hour observation which persisted until the 48 hour reading (one animal) or diminished at day 7 (one animal) or day 14 (one animal). No oedema was observed within the 14 days after treatment. Slight to moderate scaling appeared at the 7 day reading in all animals and disappeared at the 14 day reading.
Local signs (mean values from 24 to 72 hours) consisted of grade 1.44 erythema and grade 0.00 oedema. All skin reactions were clear within 14 days after treatment. The test material caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any measuring interval.
Under the conditions of the study, the test material was found to be not irritating to the skin of New Zealand White rabbits.
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