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EC number: 813-338-6 | CAS number: 106155-02-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Auto flammability
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- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
- Stability
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- 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:
- 30/9/1996 to 21/1/1997
- 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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- the control group was treated with ethanol to detect a possible irritating effect. During first induction appl. 0,1mL of different test article conc. were applied to skin area of 2cm2 instead of 8cm2. No incidence noted
- GLP compliance:
- yes
- Type of study:
- open epicutaneous test
- Justification for non-LLNA method:
- A skin sensitisation study carried out on guinea pigs in 1997 and according to TG OECD 406 is available.
Test material
- Reference substance name:
- (E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol
- Cas Number:
- 106155-02-6
- Molecular formula:
- C13H22O
- IUPAC Name:
- (E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol
- Reference substance name:
- (Z)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol
- Cas Number:
- 106155-03-7
- Molecular formula:
- C13H22O
- IUPAC Name:
- (Z)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- other: liquid
Constituent 1
impurity 1
impurity 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. (Switzerland)
- Age at study initiation: 5-7 weeks at acclimatization start
- Weight at study initiation: 344-432 g at acclimatization start
- Housing: Individually in wire mesh type-3 cages. Air conditioned with 10-15 air changes/h, RT=22ºC, relative humidity 40-70%, 12h artificial light/12h dark, music during light period
- Diet (e.g. ad libitum): pelleted standard diet ad libitum
- Water (e.g. ad libitum): community tap water ad libitum. oce weekly additional supply of ascorbic acid approx 1g/L via drinking water
- Acclimation period: 1 week
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25%, 15%, 10%, 5%
Induction 50, 25, 15 and 10% - Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- 25%, 15%, 10%, 5%
Induction 50, 25, 15 and 10% - Adequacy of challenge:
- not specified
- No. of animals per dose:
- 6 animals per dose and 6 animals as control group
- Details on study design:
- RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 20 applications
- Exposure period: 26 days (4 weeks)
- Test groups: Groups 2 to 5 (6 animals each)
- Control group: Group 1 (6 animals)
- Site:clipped right flank skin
- Frequency of applications:5 times per week
- Duration:4 weeks
- Concentrations:50, 25, 15, 10%
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1
- Exposure period: 72h
- Test groups: Groups 2 to 5 (6 animals each)
- Control group: Group 1 (6 animals)
- Site: right flank skin
- Concentrations: 25, 15, 10, 5 %
- Evaluation (hr after challenge): 24, 48, 72h - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5, 10, 15, 25%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5, 10, 15, 25%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 5,10,15,25%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5,10,15,25%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 5,10,15,25%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 5,10,15,25%. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 6
- Clinical observations:
- No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 4
- Total no. in group:
- 6
- Clinical observations:
- No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 4.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
- Key result
- Reading:
- other: 3rd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Clinical observations:
- No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 3rd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 25%. No with. + reactions: 1.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
- Key result
- Reading:
- other: 1st,2nd,3rd reading (24,48,72h)
- Group:
- test chemical
- Dose level:
- 5,10,15 %
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st,2nd,3rd reading (24,48,72h). Group: test group. Dose level: 5,10,15 %. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: No deaths during the treatment so no necropsies performed. No symptoms of systemic toxicity observed. The bodyweight of the animals was within the range of physiological variability known for this strain and age.
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is considered to possess no skin sensitization (contact allergenic) potential in albino guinea pigs
- Executive summary:
With the procedure used in this experiment, no difference between the test groups and the control group were evident after the challenge application of the test substance. The positive skin reactions and their intensity observed after the challenge at 25% correspond to the irritant potential of the test article determined before starting the induction (pretest). The test substance is therefore considered to possess no skin sensitization (contact allergenic) potential in albino guinea pigs
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