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EC number: 271-282-2 | CAS number: 68527-77-5
- 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:
- 1981, June 1 - 1981, July 8
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- The in vivo information is retrieved from a Buehler test which was conducted before the REACH regulation on requesting in vitro information, came into force (October, 2016)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1981
- Deviations:
- yes
- Remarks:
- The test item is from IFF and therefore according to internal standards. Ten animals are used in the treatment group and 5 in the negative control group in view of the positive result this does not affect the outcome of the study.
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA method was not available yet by the time the study was conducted. An appropriate Buehler test is available which would not justify conducting an additional LLNA due to animal welfare.
Test material
- Reference substance name:
- rel-[(1R,2R,6R)-2,4,6-trimethylcyclohex-3-en-1-yl]methanol
- Molecular formula:
- C10H18O
- IUPAC Name:
- rel-[(1R,2R,6R)-2,4,6-trimethylcyclohex-3-en-1-yl]methanol
- Test material form:
- liquid
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Perfection Breeders, Inc., Douglasville, Pennsylvania
- Age at Acclimatization Start: No data
- Weight at Acclimatization Start: 290 - 500g
- Housing: Fill: two per cage in stainless steel wire mesh cages
- Diet: free access to Wayne Guinea Pig diet
- Water: free access to tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS (set to maintain)
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12
- IN-LIFE DATES: From: June 1, 1981 To: July 8, 1981
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol
- Concentration / amount:
- test substance: 0.4 mL 60%
- Day(s)/duration:
- 3 times/week for 3 weeks (total 9 exposures), 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol
- Concentration / amount:
- Test substance: 0.4 mL 60%
- Day(s)/duration:
- 17 days after last induction, 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Test animals: 10
Positive Control animals: 10
Negative Control animals: 5 - Details on study design:
- RANGE FINDING TESTS
Four unexposed animals were exposed to 0.4 mL 20%, 40%, 60% and 100% concentration of the test substance by patching technique as described for main study. Treated sites were scored at 24 hours. The highest non-irritating concentration was 60%.
MAIN STUDY
A. INDUCTION EXPOSURE
The dorsal area of each animal was clipped free of hair 24 hours pior to the 1st, 4th, 6th and challenge applications of the test material. The shaved area was approx. 5 x 10 cm, i.e. 10% of the body surface. The test area was divided into three application sites, which were dosed on a rotating basis. The test material was applied beneath a 20 x 20 mm Webril pad on a 37 x 40 mm Readi-Bandage, and covered with dental dam held in place with a suitable bandage. Animals were exposed for 6 hours after which the dams and patches were removed. The treated sites were examined after each dosing day and scored at 24 and 48 hours. This procedure was performed three times weekly for three weeks (total 96-hour insults)
- Concentration: 60% in ethanol (control animals: ethanol 95% (negative) or 0.3% DNCB in 80% ethanol (positive))
- Amount: 0.4 mL
- Area: 4 cm2
- Exposure period: 6 hours (occlusive)
- Readings: 24 and 48 hours after patch removal
B. CHALLENGE EXPOSURE (control and test group)
Twenty-four hours after the challenge all animals were depilated with Neet Cream Hair Remover (Whitehalll Laboratories) for no more than 30 minutes after which the depilatory was thoroughly washed off.
- Day of challenge: approximately 17 days after last epidermal induction application
- Concentrations: 60%
- Exposure period: 6 hours (occlusive)
- Sites: site of sensitizing exposure and second naive site
- Amount: 0.4 mL
- Readings: 24 (a minimum of two hours after depilation) and 48 hours after patch removal - Challenge controls:
- Control group was treated with 0.4 mLvehicle (Ethanol 95%) during induction phase and challenged with 0.4 mL 60% test substance.
- Positive control substance(s):
- yes
- Remarks:
- DNCB
Results and discussion
- Positive control results:
- The results of the positive control animals show that the system is responsive (9/10 and 5/10 animals reacted positive at the induction site and naive site, respectively)
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: negative control - induction and naive site
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: negative control - induction and naive site
- Dose level:
- 60%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group - induction site
- Dose level:
- 60%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Animals showed slight or confluent or moderate patchy erythema (mean score 0.9)
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: test group - naive site
- Dose level:
- 60%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Animals showed slight or confluent or moderate patchy erythema (mean score 0.8)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group - induction site
- Dose level:
- 60%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Animals showed slight or confluent or moderate patchy erythema (mean score 1.2)
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: test group - naive site
- Dose level:
- 60%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Animals showed slight or confluent or moderate patchy erythema (mean score 0.7)
Any other information on results incl. tables
Observations:
Slight edema was present and erythema was observed during induction at 48 hours post dose 3 with test material. In positive control animals erythema was observed during induction at 24 hours post dose 9 and 48 hours post dose 3, 4, and 8. No irritation was observed in the negative control animals during induction or challenge periods.
One control animal was found dead on day 29.
Applicant's summary and conclusion
- Interpretation of results:
- other: Sensitising
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- In a Buehler test performed similar to OECD 406 (1981) and according to GLP principles, the substance is considered a skin sensitiser.
- Executive summary:
The skin sentisation potential of the substance was investigated by performing a Buehler test similar to OECD 406 (1981) and according to GLP principles. Ten animals were used in the treatment group and 5 in the negative control group (instead of 20 resp. 10 animals according the guideline). A concentration of 60% was used for the inductions (total of 9) and the challenge. After the inductions, patchy erythema was observed among the animals. After the challenge with the substance 8 of the 10 and 7 of 10 animals showed slight or confluent or moderate patchy erythema (score 1) at the naive site at 24 and 48 hours, respectively. At the induction site slightly more effects were observed. Reliable negative (no response during challenge) and positive controls were included. Based on the positive results, the substance is considered to be a sensitiser under the conditions of the test.
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