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EC number: 607-858-0 | CAS number: 260781-16-6
- 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:
- 1993-10-11 to 1993-10-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Deviations from the OECD 404 (2015): 4 animals were tested instead of 3. Systemic effects were not investigated. 5 test item concentrations were tested (undiluted, 1, 5, 10, and 25 %). 30 min. observation was conducted instead of a 1 h observation. In one animal the skin effects were not reversible by 72 h, but still the study was terminated.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992-07-17
- Deviations:
- yes
- Remarks:
- 4 animals were tested instead of 3. Toxic effects not investigated. 5 test item concentrations were tested. 30 min. observation was conducted instead of a 1 h observation. skin effects in 1 animal not reversible by 72 h, but the study was terminated.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 1993-09-23
Test material
- Reference substance name:
- 1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol
- EC Number:
- 607-858-0
- Cas Number:
- 260781-16-6
- Molecular formula:
- C14H26O4
- IUPAC Name:
- 1-[({[(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl]oxy}carbonyl)oxy]propan-2-ol
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Mol:Russian
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - SPF albino rabbits
- Weight at study initiation: 2.3 - 2.9 kg
- Housing: kept in single PPL cages, 45 x 55 cm, with perforated floor
- Diet (ad libitum): feed pellets "Altromin 2123"
- Water (ad libitum): drinking water acidified with hydrochloric acid to pH 2.5
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 3°C
- Relative humidity: 55 ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the undiluted test substance
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 0.5 mL of diethyl phthalate - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 4 female rabbits
- Details on study design:
- TEST SITE
- Area of exposure: area of 10 x 10 cm on the back
- Type of wrap if used: to a patch (2.5 x 2.5 cm) the test substance or vehicle was applied and the patch were placed on the back. The gauze patch was secured with adhesive type and fixed with Scanpor tape loosely wound round the trunk.
REMOVAL OF TEST SUBSTANCE
- Washing: treated skin was cleaned with soap and lukewarm water
- Time after start of exposure: 4 hours
OBSERVATION TIME POINTS
30 minutes as well as 24, 48, and 72 hours after application
SCORING SYSTEM: according to the Draize scale
- Method of calculation: scores for erythema and oedema formation for the last 3 readings of each rabbit (24, 48 and 72 hours) for each test concentration were obtained separately and divided by 3. The results are the mean scores for erythema and oedema formation of the individual rabbit.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: not specified, if skin reaction was reversible, since the observation period lasted only 72 hours and was not extended unitl reversal occurred or 14 days had elapsed.
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- other: observation was only made at the 48 hour observation
- Remarks on result:
- other: reading of 100% test concentration
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading of 100% test concentration
- Irritant / corrosive response data:
- At the one hour reading very slight erythema (grade 1) was observed in three rabbits. One of these rabbits still showed a very slight erythema (grade 1) at the 24 and 48 hour observations and another rabbit of these three rabbits showed the same reaction at the 24, 48, and 72 hours observations.
Lastly, one rabbit only showed very slight erythema (grade 1) at the 48 hour observation.
Apart from that no signs of skin reaction were recorded.
Any other information on results incl. tables
TEST CONCENTRATIONS:100%, 25 %, 10 %, 5 %, and 1 % (w/w) plus vehicle
No signs of skin irritation were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance is not irritating to the skin based on an in vivo study (OECD 404).
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant. - Executive summary:
The skin irritation potential of the substance was investigated according to the OECD guideline 404 (1992). A single dose of 0.5 mL of the undiluted substance was applied to the skin of four female Mol: Russian rabbits and covered semi-occlusive for an exposure period of 4 hours. The test sites were examined for skin reactions after test item treatment and scored according to the Draize scale after 30 minutes as well as 24, 48 and 72 hours after application.
The following results were recorded:
Animal #1
Erythema: 0
Oedema: 0
Animal #2
Erythema: 0.67
Oedema: 0
Animal #3
Erythema: 1
Oedema: 0
Animal #4
Erythema: 0.33
Oedema: 0
At the one hour reading very slight erythema (grade 1) was observed in three rabbits. One of these rabbits still showed a very slight erythema (grade 1) at the 24 and 48 hour observations and another rabbit of these three rabbits showed the same reaction at the 24, 48, and 72 hours observations. Lastly, one rabbit only showed very slight erythema (grade 1) at the 48 hour observation. Apart from that no signs of skin reaction were recorded.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classification as skin irritant.
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