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Diss Factsheets
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EC number: 930-389-0 | 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:
- 2004-10-04 to 2004-10-27
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- , 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- , 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2000-08-02
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): PI-23513, 4-(3-methylbutyl)cyclohexanol
- Substance type: technical product
- Physical state: liquid, colourless
- Storage condition of test material: ambient temperature, dry, dark
no further significant details stated
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology KG, Löhnsdorf/Post Wankensdorf, Germany
- Age at study initiation: approx. 4.5 month
- Weight at study initiation: animal 1: 2.2 kg, animal 2: 2.3 kg, animal 3: 2.5 kg
- Housing: singly in cages before and after exposure; singly in restrainers which allow free movement of the head during exposure period
- Diet: ssniff K-H V2333, ad libitum before and after exposure
- Water: ad libitum before and after exposure
- Acclimation period: at least 20 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): RT of 20 °C +/- 3 °C
- Humidity (%): 30 % - 70 %
- Photoperiod (hrs dark / hrs light): 12/12
no further significant details stated
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/patch and animal
- Concentration (if solution): 100 %
no further significant details stated - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 12 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk, the surrounding untreated skin served as a control.
- coverage: 6 qcm
- Type of wrap if used: gauze patch, held in contact with the skin with a non-irritating tape
REMOVAL OF TEST SUBSTANCE
no residual test item had to be removed at the end of exposure
EXAMINATION
- after patch removal, scores were taken after 60 min, 24, 48, 72 hours, and 4 to 12 days
SCORING SYSTEM:
- Erythema and eschar formation: no erythema (0), very slight erythema (1), well-defined erythema (2), moderate to severe erythema (3), severe erythema to slight eschar formation preventing erythema reading (4)
- Oedema formation: no oedema (0), very slight oedema (1), slight oedema (2), moderate oedema (3), severe oedema (4)
no further significant details stated
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours after patch removal
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- within 11 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours after patch removal
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- within 11 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours after patch removal
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- within 11 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours after patch removal
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible
- Remarks:
- within 8 days
- Irritant / corrosive response data:
- - erythema (grade 1): observed in all animals 60 min to 72 h, in 2/3 animals 7 days, and 1/3 animal 5-6 days after patch removal
- oedema (grade 2): observed in all animals 4 days, in 2/3 animals until 6 days after patch removal - Other effects:
- - induration and laceration of the skin in 2/3 animals 4-7 days, and 1/3 animal 5 to 10 days after patch removal
- peeling of the skin in all animals 10 to 11 days, in 1/3 animals since 9 days and in 1/3 since 7 days after patch removal
- no systemic intolerance reactions
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- There were no systemic intolerance reactions. Nevertheless, according to the EC-Commission directive 67/548/EEC and the results obtained under the present test conditions, PI-23513 requires classification with "irritating to skin".
- Executive summary:
Induration and laceration of the skin was observed in aninmal nos. one and three 4 to 7 days, in animal no. two 5 to 10 days, laceration of the skin in animal no. one until 8 days after patch removal. Peeling of the skin was observed in all animals 10 to 11 days, in animal no. one since 9 days and in animal no. three since 7 days after patch removal.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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