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EC number: 952-480-4 | CAS number: -
- 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:
- 30 Aug 1983 to 02 Sep 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- non-GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- other: Bioassay Systems Protocol, Primary Dermal Irritation Test
- Version / remarks:
- EPA-1982
- GLP compliance:
- no
Test material
- Reference substance name:
- (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl rel-acetate
- Molecular formula:
- C12H22O2
- IUPAC Name:
- (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl rel-acetate
- Reference substance name:
- (1R,2R)‐2,6,6‐trimethylcycloheptyl rel‐acetate
- Molecular formula:
- C12H22O2
- IUPAC Name:
- (1R,2R)‐2,6,6‐trimethylcycloheptyl rel‐acetate
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Pine Acres Rabbitry W. Brattleboro, VT
- Age at study initiation: 11 - 15 weeks
- Weight at study initiation: 2.5 - 3.0 kg
- Diet: Agway Prolab Rabbit Formula, Lot # Wl 32189
IN-LIFE DATES: From 30 Aug 1983 To 02 Sep 1983
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL per 1 inch square, four gauze pads per animal
- Amount applied for the negative control: an 1 inch square gauze (sponge) pad per animal without test material. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 to 60 minutes, 24, 48 and 72 hours
- Number of animals:
- 6
- Details on study design:
- TREATMENT PROCEDURE
Approximately 24 hours prior to treatment, the fur on the sides of each animal was closely clipped with care taken not to abrade the skin. A 0.5 mL aliquot of the test sample was introduced under a 1 inch x 1 inch gauze pad previously secured to the test site with surgical tape. Four pads were enployed, each one for a separate sample. Two different test sample pads were placed on the left side, and two more different test sample pads were placed on the right side. A 1 inch x 1 inch gauze pad was applied to an untreated site on the left side of each animal to serve as the control. The animals were then wrapped with an impervious covering (plastic wrap) and then stockinette to prevent removal of the patches by the animal. Patches were removed after 4 hours and the test and control sites were examined for erythema/eschar and edema formation 30 - 60 minutes after patch removal. The test and control sites were again examined at 24, 48, and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal: #1, #2, #3, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No erythema and no oedema were observed at any of the patch sites on all six animals. All patch sites had scores of 0 during the observation periode.
Any other information on results incl. tables
Table 1: Primary dermal irritation test: observations Erythema/Oedema
|
|
Test site |
Control Site |
||||||
Animal # |
Weight (kg) 0hr |
30-60 min |
24 hr |
48 hr |
72 hr |
30-60 min |
24 hr |
48 hr |
72 hr |
1 |
2.9 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
2 |
2.6 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
3 |
2.9 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
4 |
2.7 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
5 |
2.5 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
6 |
3.0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not skin irritating
- Remarks:
- according to EU CLP (EC No 1272/2008 and its amendments)
- Conclusions:
- The substance does not cause skin irritation in the dermal irritation study in rabbits (OECD TG 404).
- Executive summary:
The skin (corrosion and) irritation potential of the substance was determined in vivo in a study equivalent to OECD TG 404. A volume of 0.5 mL of unchanged substance per gauze pad with a total of 4 gauze pads per animal was administered to the clipped back of 6 male adult albino rabbits (New-Zealand White) for 4 hours under semi-occlusive conditions. The patch sites were observed for signs of erythema and oedema, and scored according to the Draize scale at 30 to 60 minutes, 24, 48 and 72 hours after patch removal.
No oedema or erythema was observed at any of the patch sites on all six (6) animals. All patch sites had scores of 0 during the observation period. In conclusion, the substance does not cause skin irritation in the dermal irritation study in rabbits.
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