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EC number: 939-719-8 | CAS number: 5502-75-0
- 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:
- 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- OECD guideline equivalent study with deviations from current methodology. Considered sufficiently reliable for the purpose of hazard assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- purity, solubility, melting/boiling point, pH of the test material not reported; sex, acclimatization period, randomization not reported; fur was removed from ventral surface; skin abraded; shaved area not measured.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- cis-4-(isopropyl)cyclohexanemethanol
- EC Number:
- 237-539-8
- EC Name:
- cis-4-(isopropyl)cyclohexanemethanol
- Cas Number:
- 13828-37-0
- Molecular formula:
- C10H20O
- IUPAC Name:
- cis-(4-propan-2-ylcyclohexyl)methanol
- Reference substance name:
- trans-(4-propan-2-ylcyclohexyl)methanol
- Cas Number:
- 13674-19-6
- Molecular formula:
- C10H20O
- IUPAC Name:
- trans-(4-propan-2-ylcyclohexyl)methanol
- Test material form:
- not specified
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: New England Rabbitry Supply Inc.
- Age at study initiation: no data
- Fasting period before study: 24 hours
- Housing: no data
- Diet :ad libitum
- water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Hair was removed from the ventral surface of the four animals and shaved areas were abraded. Note that the report description of methods and data values clearly show 6 animals in the test group but describes shaving and abrasion of the test site for 4 animals. The status of the remaining 2 animals is unclear and the report does not provide information on these remaining animals. Therefore it seems likely that all 6 animals had shaved and abraded skin and the statement regarding just 4 was erroneous.
TEST SITE
- Area of exposure: ventral surface
- % coverage: no data
- Type of wrap if used: gauze bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data
- Constant concentration used: 100% test material
VEHICLE: no - Duration of exposure:
- 24 hours
- Doses:
- 2,000 mg/kg
- No. of animals per sex per dose:
- 6 per group
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: daily observations for signs of dermal irritation.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (recorded 2 and 4 hours post-application and daily thereafter) and body weight (recorded prior to application, 7 days post-application, and at termination). - Statistics:
- not required
Results and discussion
- Preliminary study:
- not applicable
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 mg/kg bw
- Based on:
- test mat.
- Mortality:
- One animal died on Day 8 (post-application).
- Clinical signs:
- other: At 24 hours post-application, all animals were noted to be lethargic and these observations persisted until Day 4 post-application. There also was a decrease in food and water consumption observed from Day 1 to Day 5 post-application.
- Gross pathology:
- At necropsy, findings in the premature decedent were limited to an enlarged gall bladder. Macroscopic examinations of the remaining animals did not reveal any adverse findings.
- Other findings:
- The test compound induced dermal irritation (erythema and edema) in the treated animals; see Table 1 and Table 2 below.
Any other information on results incl. tables
Table 1 Erythema Scores of Test Compound 0778/3 in the Rabbit*
Animal No. |
19 |
20 |
21 |
22 |
23 |
24 |
Day No. |
|
|
|
|
|
|
1 |
2 |
2 |
1 |
2 |
2 |
1 |
2 |
4 |
4 |
2 |
3 |
2 |
3 |
3 |
4 |
4 |
2 |
3 |
2 |
3 |
4 |
4 |
4 |
2 |
3 |
2 |
3 |
5 |
4 |
4 |
2 |
3 |
2 |
3 |
6 |
4 |
4 |
1 |
3 |
2 |
3 |
7 |
4 |
4 |
1 |
3 |
2 |
3 |
8 |
3 |
3 |
0 |
- |
1 |
3 |
9 |
3 |
3 |
0 |
- |
1 |
2 |
10 |
2 |
2 |
0 |
- |
0 |
2 |
11 |
2 |
2 |
0 |
- |
0 |
2 |
12 |
1 |
1 |
0 |
- |
0 |
1 |
13 |
1 |
1 |
0 |
- |
0 |
1 |
14 |
1 |
0 |
0 |
- |
0 |
0 |
* The degree of dermal irritation was scored according to the Draize method.
Table 2 Edema Scores of Test Compound 0778/3 in the Rabbit*
Animal No. |
19 |
20 |
21 |
22 |
23 |
24 |
Day No. |
|
|
|
|
|
|
1 |
2 |
2 |
0 |
1 |
1 |
0 |
2 |
3 |
3 |
0 |
1 |
2 |
2 |
3 |
3 |
3 |
0 |
1 |
2 |
2 |
4 |
4 |
4 |
0 |
1 |
2 |
2 |
5 |
3 |
3 |
0 |
0 |
1 |
1 |
6 |
2 |
2 |
0 |
0 |
1 |
1 |
7 |
0 |
0 |
0 |
0 |
0 |
0 |
8 |
0 |
0 |
0 |
- |
0 |
0 |
9 |
0 |
0 |
0 |
- |
0 |
0 |
10 |
0 |
0 |
0 |
- |
0 |
0 |
11 |
0 |
0 |
0 |
- |
0 |
0 |
12 |
0 |
0 |
0 |
- |
0 |
0 |
13 |
0 |
0 |
0 |
- |
0 |
0 |
14 |
0 |
0 |
0 |
- |
0 |
0 |
* The degree of dermal irritation was scored according to the Draize method.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 dermal, rabbit > 2,000 mg/kg
- Executive summary:
The dermal LD50 of the test compound was determined to be greater than 2,000 mg/kg body weight in this study. The one mortality noted during this study was considered unrelated to the application of the test compound as similar gross pathological findings (enlarged gall bladder) were not observed in the remaining animals at necropsy. While dermal irritation (erythema and/or edema) was observed in all animals, it should be noted that the test compound was applied to the ventral surface of the animals on shaved and abraded skin (a deviation according to OECD Guideline 402). It is worth noting that there is an apparent inaccuracy in the study report. The report states that there were six animals in the treatment group while a subsequent sentence states that "the four" animals were shaved and had shaved skin abraded. As the remainder of the report does not differentiate between animals with shaved/abraded skin and any that might have been unshaven/unabraded, it is assumed that all animals were in fact shaved and their shaved skin was abraded. Abrading the skin could have altered its permeability. It also was unclear in the study report whether residual test substance was removed (with water or an appropriate solvent) at the end of the 24-hour exposure period. Despite the deviations noted in the study design, the LD50 is considered not to be affected.
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