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EC number: 904-653-0 | 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that the properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol can be predicted by studies conducted with the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol, because the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol contains phenol (40-45%, typical concentration ca. 40%) and 4,4’-isopropylidenediphenol (BPA) (20-40%, typical concentration ca. 33%) as main constituents. Both constituents are data rich substances with distinct hazard properties, so that mainly data on the constituents have been applied to characterize the Reaction mass of phenol and 4,4’-isopropylidenediphenol. Since this is a common approach in mixture hazard assessment, is reasonable to apply it also to multi-constituent substances.
Additionally, some data from a structurally related substance (2-acetone, polymer with phenol) containing the same constituents/impurities at different concentrations are available, which are applied to characterize the environmental fate and ecotoxicity of the impurities present in the Reaction mass of phenol and 4,4’-isopropylidenediphenol.
This read-across hypothesis corresponds to scenario 2 - different compounds have qualitatively and quantitatively the same type of effects - of the read-across assessment framework i.e. properties of the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol are predicted to be similar to those of the source substances phenol, 4,4’-isopropylidenediphenol (BPA), and 2-acetone, polymer with phenol.
Therefore, read-across from the available studies with the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
please refer to justification for read-across attached to Iuclid section 13
3. ANALOGUE APPROACH JUSTIFICATION
please refer to justification for read-across attached to Iuclid section 13
4. DATA MATRIX
please refer to justification for read-across attached to Iuclid section 13
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- No study according to current Guidelines but meets scientific standards with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 24 h exposure). Phenol is a constituent of the reaction mass so that phenol hazard data are applied in the hazard assessment.
- Principles of method if other than guideline:
- FHSA method of August 12, 1961, pages 7333-7341
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no details available
- Type of coverage:
- not specified
- Preparation of test site:
- other: abraded or intact
- Vehicle:
- physiological saline
- Controls:
- not required
- Amount / concentration applied:
- test substance moistened with physiological saline
- Duration of treatment / exposure:
- 24 h
- Observation period:
- up to 72 h after exposure
- Number of animals:
- 6
- Details on study design:
- intact or abraded areas of the skin of the bellies of rabbits exposed for a maximum period of 24 hours;
no further details - Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- other: necrosis of the intact skin; scoring estimated from description of effects
- Irritant / corrosive response data:
- no further details available
- Other effects:
- no data about systemic effects
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Corrosive properties in rabbits after application of 0.5 g to the intact skin and max. exposure duration of 24 h.
- Executive summary:
No study according to current Guidelines but meets scientific standards with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; 24 h exposure).
Six rabbits received 0.5 g phenol moistened with physiological saline to the intact or abraded skin of the belly (exposure period max. 24 h and scoring 24 and 72 after exposure. Since the material produced necrosis of the intact skin, it is classified by the authors as a corrosive substance.
Conclusion: Corrosive properties in rabbits after application of 0.5 g to the intact skin and max. exposure duration of 24 h.
Phenol is a major component of the reaction mass and by its toxicity drives the hazard of the rection mass, so that phenol hazard data are applied in the hazard assessment.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-General information: Three male animals approximately 5-10 months of age with initial body weights of 2.4-2.6 kg were used.
-Diet: Ad libitum before and after the exposure period. Standard rabbit diet of Altromin 2023 (ALTROMIN GmbH, D-32791 Lage/Lippe). Food was analysed at least twice per year for contaminants.
-Drinking water: Water was offered ad libitum before and after the exposure period. Water samples were analysed twice per year for contaminants and once per year for a bacteriological investigation.
-Housing: Before and after the exposure period, animals were kept singly in cages measuring 425 mm x 600 mm x 380 mm (manufacturer: Dipl. Ing. W. EHRET GmbH, D-16352 Schonwalde). During the exposure period, animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn. The cages excluded irritation of the skin by excrement and urine.
-Acclimation period: At least 20 days.
ENVIRONMENTAL CONDITIONS
-Temperature: 17-23 degrees C
-Humidity: 30-70%
-Photoperiod: 12 hours light (150 lux at approximately 1.5 meter room height)/12 hours dark - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg BPA per animal. 4000 mg of the test compound was mixed with 2 ml water and 750 mg of this paste was applied per animal.
- Duration of treatment / exposure:
- Four hours.
- Observation period:
- 72 hours.
- Number of animals:
- Three male animals.
- Details on study design:
- Three male Himalayan rabbits were shaved on the dorsal trunk area. Only animals with healthy, intact skin were used. Approximately 24 hours after shaving, a dose of 500 mg BPA per animal was applied to the test site (approximate area of 6 square cm) and covered with a gauze patch that was held in place with non-irritating tape for the duration of the exposure period. The surrounding untreated skin served as a control. The exposure time was four hours. After exposure, the patch was removed and the scores of the resulting reactions were taken 60 minutes, 24, 48, and 72 hours after patch removal.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 60 minutes
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No substance-related lesions were observed at any time point. All animals had skin irritation scores of zero at all time points for both erythema and edema.
- Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The authors concluded that there were no substance-related lesions from the acute skin irritation test with BPA.
- Executive summary:
Three male Himalayan rabbits were shaved in the dorsal trunk area and 24 hours later, 500 mg BPA per animal was applied to the test site. The surrounding untreated skin served as a control. The exposure period was four hours, after which the patch was removed and the resulting reactions were examined and scored at 60 minutes, 24, 48, and 72 hours after patch removal. The skin irritation scores for each animal were zero for erythema and edema at all time points. The authors concluded that there were no BPA-related lesions at any time point and there were no systemic intolerance reactions.
BPA is one of the two main components (ca. 33%) of the reaction mass so that its hazard data are relevant for the hazard assessment of the reaction mass. This BPA study has been included as supporting study to demonstrate that BPA is not irritating to skin so that phenol (corrosive) data are used for hazard characterisation of the reaction mass.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- No Guideline study but meets scientific standards with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 1 minute dermal exposure). Phenol is a constituent of the reaction mass so that phenol hazard data are applied in the hazard assessment.
- Principles of method if other than guideline:
- Assessment of skin decontamination procedures after short term exposure to phenol
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: CFE
- Details on test animals or test system and environmental conditions:
- 12-14 weeks old
pathogen free rats
certified diet and water ad libitum
no further data - Type of coverage:
- open
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- undiluted (phenol molten at 45°C)
1 ml/kg bw (appr. 1050 mg/kg bw) - Duration of treatment / exposure:
- 1 minute
- Observation period:
- 7-10 days
- Number of animals:
- 5 males and 5 females per experimental design
- Details on study design:
- After 1 minute the exposure was terminated by a) spraying for 45 s with an appropriate solvent, b) quickly wiped over, or c) swabbed over (piece of cotton soaked with the solvent).
Licking of exposed skin was prevented by collar. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- other: local effects
- Basis:
- mean
- Time point:
- other: not clearly stated
- Reversibility:
- not reversible
- Remarks:
- (necrosis)
- Remarks on result:
- other: mild to severe burns depending on decontamination type
- Irritant / corrosive response data:
- severe burns after quick wiping
mild burns after 120 s swabbing with water or other solvents - Other effects:
- systemic effects were reported using water as solvent for spraying-decontamination of quick wiping: hematuria & convulsions.
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- Severe burns were reported in rats after exposure to the undiluted test substance for 1 minute.
- Executive summary:
No Guideline study but meets scientific standards with acceptable restrictions (partly limited documentation, e.g. no details about the test substance; only 1 minute dermal exposure).
The study was related to the decontamination properties of different solvents and to the methods of application of these solvents. Five rats per sex per experimental design received 1 ml/kg bw (presumably less than 0.5 ml per animal assuming a body weight of 300 -500 g) to the shaved skin; the exposure was terminated in each experiment after 1 minute by spraying the appropriate solvent, swabbing the solvent for 10 -120 seconds or quick wipning with a ptch soaked with the solvent. Phenol induced mild to severe burns depending on the solvent used for decontamination and the method used for application of the solvent. However, there is evidence that chemical burns were induced by phenol even after an exposure period of 1 minute.
Severe burns were reported in rats after exposure to the undiluted test substance for 1 minute.
Phenol is a major component of the reaction mass and by its toxicity drives the hazard of the rection mass, so that phenol hazard data are applied in the hazard assessment.
Data source
Materials and methods
Test material
- Reference substance name:
- Reaction mass of 4,4'-isopropylidenediphenol and phenol
- EC Number:
- 904-653-0
- IUPAC Name:
- Reaction mass of 4,4'-isopropylidenediphenol and phenol
Constituent 1
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- corrosive
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Remarks on result:
- positive indication of irritation
- Remarks:
- corrosive
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- No experimental data are available for the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol. However, based on the general principles of mixture toxicology, data on the main constituents of this multi-constituent substance are used as surrogate. Due to the corrosive properties of Phenol, the the target substance Reaction mass of phenol and 4,4’-isopropylidenediphenol is also considered to be corrosive.
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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