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EC number: 212-611-1 | CAS number: 831-82-3
- 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
Endpoint summary
Administrative data
Description of key information
Based on Analogue approach (3 -phenoxyphenol), the oral LD50 is determined to be equal to 1 600 mg/kg bw for 4 -phenoxyphenol.
An acute dermal toxicity study performed according to OECD 402 resulted in an LD50 of > 2 000 mg/kg bw.
On the basis of the rules for adaptation in Column 2 of the REACH Annex VIII, no inhalation acute toxicity was performed. Furthermore based on the OECD n°110 test showing that the majority of the particule size (92.3%) was between 45 and 125 µm, there is no alveolar fraction and systemic effect after inhalation is not expected.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The hypothesis is that 4-phenoxyphenol and 3-phenoxyphenol have the same behaviour for the acute toxicity.
2. ANALOGUE APPROACH JUSTIFICATION
According the position of polar group (-OH), it can be considered than the para and meta phenoxyphenol are the same breakdown process in the organism and they have the same order of magnitude of responsiveness.
This approach is justified by dermal acute toxicity : both isomers are the same magnitude of toxicological effect (> 2000 mg/kgbw) - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across: supporting information
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- ca. 1 600 mg/kg bw
- Based on:
- other: 3-phenoxyphenol
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The approximative LD50 (rat) for 4-PhenxyPhenol, per oral, is determined as equal that LD50 for 3-phenoxyphenol : 1 600 mg/kgbw.
- Executive summary:
The approximative LD50 (rat) for 4-PhenxyPhenol, per oral, is determined as equal that LD50 for 3-phenoxyphenol : 1 600 mg/kgbw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 600 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The rules for adaptation in Column 2 of the REACH Annex VIII state that, “in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 [inhalation and dermal acute toxicity] shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided”. The rules for adaptation also state that, “Testing by the dermal route is appropriate if…inhalation of the substance is unlikely…”. As oral and dermal routes of exposure are more relevant, testing for acute inhalation toxicity is therefore waived based on this information.Furthermore on the basis of the OECD n° 110 test the majority of the particle size (92.3%) was between 45 and 125 µm. Therefore there is no alveolar fraction and systemic effect after inhalation is not expected.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch n°20180328
- Expiration date of the lot/batch:28 March 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: Yes - Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: JANVIER LABS (53940 Le Genest St Isle – France)
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8 - 9 weeks old
- Weight at study initiation: 219.3 g +/- 8 g (mean)
- Housing: individual cage
- Diet :ad libitum (ENVIGO 2016)
- Water : ad libitum (tap-water from public distribution system - Microbiological and chemical analyses of the water were carried out once every 6 months)
- Acclimation period: Yes - Five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C to 25°C
- Humidity (%): 30% to 70%
- Air changes (per hr): ten changes cycles per hour
- Photoperiod (hrs dark / hrs light): 12h dark / 12h light
- Type of coverage:
- open
- Vehicle:
- DMSO
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: 10%
- Type of wrap if used: wides hypoallergenic microporeTM adhesive tape from 3M
REMOVAL OF TEST SUBSTANCE
- Washing : Yes (distiled water)
TEST MATERIAL
- Amount(s) applied: 1.006 g with 5 ml of DMSO or 2.006 g with 10 mL of DMSO
VEHICLE
- Amount(s) applied: 10 mL/kgbw - Duration of exposure:
- 24 hours
- Doses:
- 2 000 mg/kgbw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 2, 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs (spontaneous activity, preer's reflex, respiratory rate, convlusions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex), body weight, Auopsy (oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovarie, uterus, skin, adrenals, pancrease), only organs presenting macroscopic anomalies can be removed and preserved in view to microscopic examination.
- These observations were compared to historical control data - Statistics:
- Mean and standard deviation
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: No systemic clinical sign
- Gross pathology:
- No gross pathology
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of the test item Paraphenoxyphenol is higher than 2000 mg/ kg body weight by dermal route in the rat.
- Executive summary:
In accordance with the OECD guideline n° 402, the 4 -Paraphenoxyphenol was applied, as supplied, onto the intact skin of 3 female Sprague Dawley rats at the dose of 2000 mg/kg body weight.
No mortality occurred during the study. No systemic clinical sign related to the administration of the test item was observed. The body weight evolution of the animals remained normal throughout the study. The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.
In conclusion, the LD50 of the test item Paraphenoxyphenol is higher than 2000 mg/ kg body weight by dermal route in the rat. The test item Paraphenoxyphenol does not have to be classified in accordance with the Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures.
Reference
Body weight and weight gain in grams
Females | D0 | D2 | D2 -D0 | D7 | D7 -D0 | D14 | D14 -D0 |
Female n°1 | 211 | 233 | 22 | 253 | 42 | 282 | 71 |
Female n°2 | 220 | 229 | 9 | 254 | 34 | 271 | 51 |
Female n°3 | 227 | 241 | 14 | 263 | 36 | 271 | 44 |
MEAN | 219.3 | 234.3 | 15.0 | 256.7 | 37.3 | 274.7 | 55.3 |
Standard deviation | 8.0 | 6.1 | 6.6 | 5.5 | 4.2 | 6.4 | 14.0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
Justification for classification or non-classification
Based on the available data, 4 -phenoxyphenol is classified, according to the CLP Regulation, H302 (oral acute toxicity, Cat. 4 - Harmful if swallowed).
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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