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EC number: 408-200-3 | CAS number: 63187-91-7 FRESCOLAT MGA
- 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 / corrosion
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well-documented experiment according to GLP and EC and OECD guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane
- EC Number:
- 408-200-3
- EC Name:
- 2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane
- Cas Number:
- 63187-91-7
- Molecular formula:
- C13H24O3
- IUPAC Name:
- [9-methyl-6-(propan-2-yl)-1,4-dioxaspiro[4.5]decan-2-yl]methanol
- 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:
- TEST ANIMALS
- Species: New Zealand White, SPF-quality
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: approx. 15 weeks
- Weight at study initiation: 2489-2733 g
- Housing: individually, cages with perforated floors and equiped with automated drinking system
- Diet (e.g. ad libitum): Standard laboratory diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands); approx. 100 g/day
- Water (e.g. ad libitum): Tap water diluted with decalcified water, ad libitum
- Acclimation period: at least 5 days before start of treatment under test conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 (artificial fluorescent light)
Fluctuations from these optimal conditions were noted, but were considered to not have affected the study integrity.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 3 (all females)
- Details on study design:
- Approx. 24 hours before treatment, the dorsal fur was shaved with electric clippers, exposing an area of approx. 100 square centimeters (10 cm x 10 cm).
Prior to test substance administration, the animals were physically examined and the shaved area of skin to be treated was normal.
On test day 1, 0.5 mL of the test substance was applied to the intact skin of the shaved area on one flank, using a surgical gauze patch 2 x 3 cm mounted on Micropore tape (3M, St. Paul, USA). The contralateral flank was similarly prepared, but without test substance, to act as a procedural control. The dressing was wrapped around the abdomen and secured with an elastic bandage (Corban, 3M, St. Paul, USA).
Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap water and subsequently a dry tissue. However, the treated skin area remained sticky after removal of the test substance.
In order to facilitate the scoring, the skin area concerned of all animals was re-shaved before the observation on days 2, 3, 4, 7 and 14.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24-48-72h
- Score:
- 4.2
- Max. score:
- 8
- Reversibility:
- fully reversible within: 14d
- Irritant / corrosive response data:
- There was no evidence of a corrosive effect on the skin.
No staining of the treated skin by the test substance was observed. - Other effects:
- No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The observed irritation resulted in a PPDI of 4.2 when applied to the intact rabbit skin. When compared to the EEC criteria for classification and labelling for dangerous susbtances (DPD), the test substance should be classified as a skin irritant (moderately irritating).
- Executive summary:
The study assesses the possible irritation or corrosion potential of the test substance in the rabbit according to OECD and EEC guidelines. The test substance was applied onto shaved skin of 3 female albino rabbits using semi-occlusive dressing for 4 hours, followed by 6 observations at approx. 1, 24, 48 and 72 hours, and 7 and 14 days after removal of the dressings and remaining test substance.
Under the conditions of the test, the test substance resulted in well-defined erythema and slight or moderate oedema. The skin irritation was reversed within 14 days after exposure in all 3 animals. No corrosive effect occurred on the skin in all 3 rabbits. In the area of application, no staining of the treated skin by the test substance was observed. No signs of systemic intoxication were observed during the study period.
The test substance resulted in a primary irritation index of 4.2 (moderately irritating) when applied to intact rabbit skin.
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