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EC number: 405-040-6 | CAS number: 63500-71-0 CIS/TRANS-TIMO; FLOROL; FLOROSA
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 Jan 1985 to 24 Jan 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- 6 rabbits (4 males, 2 females) were used for this study. Skin application site was abraded on 50% of the animals to enhance dermal penetration
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- EC Number:
- 405-040-6
- EC Name:
- A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol
- Cas Number:
- 63500-71-0
- Molecular formula:
- C10 H20 O2
- IUPAC Name:
- 4-methyl-2-(2-methylpropyl)oxan-4-ol
- Details on test material:
- - Name of test material (as cited in study report): MT-178
- Substance type: pure active substance
- Lot/batch No.:
- Expiration date of the lot/batch:
- Storage condition of test material: The test article was stored at ambient room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ace Animals USA
- Age at study initiation: no data
- Weight at study initiation: 2.2 - 2.5 kg
- Fasting period before study:
- Housing: animals were housed 2/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet (e.g. ad libitum): ad libitum, Fresh Purina Rabbit Chow (Diet #53-21)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: 10 Jan 1985 To: 24 Jan 1985
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: abdomen
- % coverage: ca. 10 % of body surface
- Type of wrap if used: The test article was covered with a gauze patch and gentle pressure was applied to the gauze to aid the distribution of the test article over the prepared site. The torso was wrapped with plastic which was secured with tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): application site was wipped
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw
- Constant volume or concentration used: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg (male and female)
- No. of animals per sex per dose:
- 4 males + 2 females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animal were observed daily. Bodyweights were recorded pretest and at termination of the test.
- Necropsy of survivors performed: yes
- Other examinations performed: toxicity and pharmacological effects, body weight, gross pathology - Statistics:
- The LD 50 and 95% Confidence were calculated, if possible, by the method of Litchfield, J.T. Jr., & F. Wilcoxon JPET 96:99, 1949 or Horn, H.J. Biometric.s 12:311, 1956.
Results and discussion
- Preliminary study:
- Not Applicable
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no death
- Clinical signs:
- other: There were no signs of toxicity. Physical signs: Three animals were normal during the 14 day observation period. Instances of few feces and yelllow nasal discharge were noted in the remaining three animals.
- Gross pathology:
- All animals were normal
Any other information on results incl. tables
Table 1: bodyweight, dose volume and dermal reactions
Rabbit # & sex |
Dose volume cc |
Weight (kg) day 0 |
Weight (kg) day 14 |
Day 1 |
Day 7 |
Day 14 |
% remaining |
|||
R |
E |
R |
E |
R |
E |
|||||
1-M ab |
5.3 |
2.5 |
2.9 |
2 |
2 |
0 f |
0 |
0 |
0 |
20 |
2-M |
4.7 |
2.2 |
2.6 |
2 |
2 |
4 |
0 |
0 |
0 |
20 |
3-M ab |
4.9 |
2.3 |
2.5 |
2 gb |
2 |
4 |
2 |
0 |
0 |
20 |
4-M |
4.9 |
2.3 |
2.7 |
2 |
0 |
0 f |
0 |
0 |
0 |
20 |
5-F ab |
4.9 |
2.3 |
2.7 |
3 |
2 |
4 |
1 |
0 f |
0 |
20 |
6-F |
4.7 |
2.2 |
2.8 |
2 |
2 |
0 |
0 |
0 |
0 |
20 |
|
||||||||||
Codes used: R =erythema(redness) E. =edema ab=abraded b = brown areas f =flaking skin g =green areas % remaining = the amount of material remaining on the skin, gauze and occlusive binding at 24 hours, after the occlusive binding was removed. |
DERMAL SCORING CODE for EVALUATION OF SKIN REACTIONS
ERYTHEMA & ESCHAR FORMATION:
0 NO ERYTHEMA
1 VERY SLIGHT ERYTHEMA (BARELY PERCEPTIBLE)
2 WELL DEFINED ERYTHEMA
3 MODERATE TO SEVERE ERYTHEMA 3
4 SEVERE ERYTHEMA (BEET REDNESS) TO SLIGHT ESCHAR FORMATION (INJURIES IN DEPTH)
EDEMAFORMATION:
0 NO EDEMA
1 VERY SLIGHT EDEMA (BARELY PERCEPTIBLE)
2 SLIGHT EDEMA (EDGES OF AREA WELL DEFINED BY DEFINITERAISING)
3 HODERATE EDEMA (RAISED APPROXIMATELY 1 MILLIMETER)
4 SEVERE EDEMA (RAI SED MORE THAN 1 MI LLIMETER AND EXTENDING BEYOND THE AREA OF EXPOSURE)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD 50 is greater than 2.0 g/kg of body weight.
- Executive summary:
Purpose of the study. The purpose of this study was to investigate the toxicity of the test article in the albino rabbit. The procedures used were equivalent to the OECD Guideline 402 on Acute Dermal Toxicity with two deviations (see below under Methods).
Method. Six healthy albino rabbits were dosed dermally in a limit test with a unique concentration of test material at a dose level of 2000 mg/kg of body weight.
Two deviations were made from the OECD Guideline: 1.) 6 animals (4 males, 2 females) were used for the study instead of 10; 2.) skin application site was abraded on 50% of the animals to enhance dermal penetration.
The test article was kept in contact with the skin for 24 hours. The animals were observed daily for signs of mortality, toxicity and pharmacological effects. Skin reactions were scored on Days 1, 7 and 14. Body weights were recorded pretest and at termination. All animals were examined for gross pathology.Results. All animals survived the 2000 mg/kg dermal application. Physical signs of few feces and yellow nasal discharge were noted during the study. Body weight changes were normal. Dermal reactions, slight to moderate on Day 1, were absent to severe on Day 7 and absent on Day 14. Necropsy results were normal.
Discussion. Study was performed using occlusive patch and skin abrasion was used in that study to increase dermal penetration and exposure. As exposure to test substance was not lethal both on more severe conditions (abreded skin, occlusive patch) and as dermal reactions were completely reversible effect after 14 days, it can be concluded that the test substance has no toxic effect on test animals despite a lower number of animals used in the study.
Conclusion. The LD50 is greater than 2000 mg/kg of body weight.
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