Registration Dossier
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EC number: 904-153-2 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 22 June 1992 - 26 June 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed to OECD test guidelines, and in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- : animals not fully observed for reversibility of effects
- GLP compliance:
- yes
- Remarks:
- Report states that the testing laboratory, Scantox, was accredited by the Danish Accreditation Scheme, however a formal certificate of accreditation was not included.
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): CTF
- Physical state: A clear, colourless liquid
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Purity test date: Not reported
- Lot/batch No.: 9201
- Expiration date of the lot/batch: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
- Other:
A read across is proposed based on structural similarities between the substances.
Test animals
- Species:
- rabbit
- Strain:
- other: SPF Albino
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Møllegard Breeding Centre ApS, Ekby, DK-4623 Lille Skensved.
- Age at study initiation: Not reported
- Weight at study initiation: 2.3 - 2.5 kg.
- Housing: Kept in single PPL cages, 45 x 55 cm, with perforated floor.
- Diet (e.g. ad libitum): Rabbits had free access to feed pellets "Altromin 2123".
- Water (e.g. ad libitum): Free access to drinking water acidified to pH 2.5 with hydrochloric acid.
- Acclimation period:At least one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours light per day (from 06h to 18h).
IN-LIFE DATES: From: 22 June 1992 To: 26 June 1992
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 mL
- Concentration (if solution): Not applicable. - Duration of treatment / exposure:
- 4 Hours
- Observation period:
- 72 hours. Observations made half an hour after removal of the dressings, and also 24, 48, and 72 hours after application of the test substance.
- Number of animals:
- 4
- Details on study design:
- TEST SITE
- Area of exposure: Two patches 2.5 x 2.5 cm on each animal
- Type of wrap if used: Gauze patches were secured with a cross of 1 cm wide adhesive tape, and fixed with Scanpor tape, 4.5 cm width, loosely wound round the trunk.
- The test site was clipped as closely as possible with an electric clipper on the day before the experiment.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was cleaned with soap and lukewarm water after removal of the dressings.
- Time after start of exposure: 4 hours.
SCORING SYSTEM: Consistent with system described in OECD test guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48, and 72 hours.
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: Slight erythema seen in one animal from 24 hours onwards, still observed after 72 hours.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: Mean of 24, 48, and 72 hours.
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Oedema not observed
- Irritant / corrosive response data:
- Very slight erythema was seen on one rabbit which persisted for the duration of the observation period; no signs of erythema or oedema were seen in any of the other three rabbits.
- Other effects:
- No other effects reported.
Any other information on results incl. tables
Very slight erythema was seen on one rabbit which persisted for the duration of the observation period; no signs of erythema or oedema were seen in any of the other three rabbits.
Mean scores for skin irritation
Observation | 0.5h | 24h | 48h | 72h | Mean (24-72h) |
Erythema | 0.00 | 0.33 | 0.33 | 0.33 | 0.33 |
Oedema | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A very mild irritant response was seen in one rabbit: the substance is not classified according to CLP.
- Executive summary:
An acute dermal irritation test was performed by Scantox, Denmark on behalf of Perstorp Polyols, Sweden (subcontracted through Toxicon, Sweden), to determine the skin irritant properties of the test substance CTF to rats. The study was conducted to GLP and according to OECD Test Guideline 404. The neat liquid test substance was applied to the skin of four female rabbits for a period of four hours. Observations of the irritant response were made shortly after the removal of the test substance, and 24, 48, and 72 hours after exposure. Very slight erythema was seen on one rabbit which persisted for the duration of the observation period (24 -72 hours); no signs of erythema or oedema were seen in any of the other three rabbits. It was concluded that CTF should not be classified as irritating to skin under the CLP Regulation.
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