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EC number: 609-063-4 | CAS number: 35113-48-5
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-ISOPROPYL-1,3-DIOXANE-5,5-DICARBOXYLIC ACID DIETHYL ESTER
- EC Number:
- 609-063-4
- Cas Number:
- 35113-48-5
- Molecular formula:
- C13H22O6
- IUPAC Name:
- 2-ISOPROPYL-1,3-DIOXANE-5,5-DICARBOXYLIC ACID DIETHYL ESTER
- Test material form:
- other: Liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animals were in the weight range of 2.0 to 3.5 kg and were twelve to sixteen weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food (Certified Rabbit Diet (Code 5322) supplied by PMI Nutrition International, Nottingham, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of the test material
- Duration of treatment / exposure:
- 4h
- Observation period:
- 1, 24, 48, 72h and 7d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:2.5*2.5
- Type of wrap if used: surgical adhesive tape
REMOVAL OF TEST SUBSTANCE
- Washing : cotton wool soaked in 74% industrial methylated spirits
- Time after start of exposure:
SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4
Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 0.66
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7d
- Remarks on result:
- other: loss of skin elasticity
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7d
- Remarks on result:
- other: loss of skin elasticity
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 7d
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: slight desquamation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- ca. 0.66
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- ca. 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 7d
- Score:
- ca. 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Very slight erythema was noted at two treated skin sites one hour after patch removal and persisted at one treated skin site at the 24, 48 and 72-hour observations.
Very slight oedema was noted at two treated skin sites one hour after patch removal and persisted at one treated skin site at the 24, 48 and 72-hour observations.
Loss of skin elasticity was noted at one treated skin site at the 48 and 72-hour observations with slight desquamation at this treated skin site at the 7-day observation.
One treated skin site appeared normal throughout the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 0.7 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted. The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 93/21/EEC.
- Executive summary:
Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted 17 July 1992)
§ Commission Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)
Results. A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema and very slight oedema. Other reactions noted were loss of skin elasticity and slight desquamation. One treated skin site appeared normal throughout the study.
Conclusion. The test material produced a primary irritation index of 0.7 and was classified as a mild irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commission Directive 93/21/EEC.
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