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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-phenoxyphenol
- EC Number:
- 212-611-1
- EC Name:
- 4-phenoxyphenol
- Cas Number:
- 831-82-3
- Molecular formula:
- C12H10O2
- IUPAC Name:
- 4-phenoxyphenol
- Reference substance name:
- Phenol
- EC Number:
- 203-632-7
- EC Name:
- Phenol
- Cas Number:
- 108-95-2
- Molecular formula:
- C6H6O
- IUPAC Name:
- Phenol
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch : 20180328 (28 March 2018)
Constituent 1
impurity 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: Batch N°20180328
- Expiration date of the lot/batch: March 2019
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier Labs (F-53941 Le Genest Saint Isle)
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 weeks old
- Weight at study initiation: Yes
- Housing: individually housed
- 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 six 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 per hour
- Photoperiod (hrs dark / hrs light): 12h dark/ 12h day
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Pre-screen test : 60%
Main study : 60% ; 40% ; 25% ; 0% (vehicule) - No. of animals per dose:
- Pre-screen test : one mouse
Main study : four mice - Details on study design:
- PRE-SCREEN TESTS:
Yes
- Application : 25 μL
- Application : the dorsal surface of each ear
- Frequence : three consecutive days (Days 1, 2, 3).
- Observation ay 1 to day 6. The bodyweight of the mouce was recorded on Day 1 (prior to dosing) and on Day 6.
MAIN STUDY
- Application : 25 μL
- Application : the dorsal surface of each ear
- Frequence : three consecutive days (Days 1, 2, 3).
- Observation : clinical and mortality : Days 1, 2, 3, 4, 5, 6 ; Bodyweights : day 1 and day 6 ; Ear Thickness measurement and recording of local reactions : Yes
- Euthanized: Day 6 (end of the test) with sodium pentobarbital (Dolethal®). The draining auricular lymph nodes from the four mice were excised. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Valid
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- ca. 1.76
- Test group / Remarks:
- 20%
- Key result
- Parameter:
- SI
- Value:
- ca. 2.27
- Test group / Remarks:
- 40%
- Key result
- Parameter:
- SI
- Value:
- ca. 2.27
- Test group / Remarks:
- 60%
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
- A single cell suspension of the lymph node cells of 4 mice was prepared.
- The lymphocyte cells were counted using a cell counter (Beckman Coulter Z2).
DETAILS ON STIMULATION INDEX CALCULATION
- The proliferation response of lymph node cells was expressed as the number of lymphocytes per lymph node and as the ratio of lymphocytes into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
EC1.4 CALCULATION
- The EC1.4 value (theoretical concentration resulting in a SI value of 1.4) was determined by linear interpolation of points on the dose-response curve, immediately above and below the 1.4-fold threshold.
CLINICAL OBSERVATIONS:
- Preliminary screening study : No mortality and no signs of systemic toxicity. No cutaneous reactions.
- Main test : No mortality and no signs of systemic toxicity (test and control animals)
- the test item has to be considered as not excessively irritant at these concentrations in accordance with the OECD criteria
BODY WEIGHTS
- Bodyweight changes of the test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period
Any other information on results incl. tables
Table : Cell count, stimulation index and calculation of EC1.4 (main study)
Groups | Test item | Cell count/ group (*106 cells/ml) | Stimulation INdex (SI) | Result | EC 1.4 value |
1 | 0% (vehicule) | 50.97 | n.a | n.a | n.a |
2 | 20% | 89.62 | 1.76 | Positive | n.a |
3 | 40% | 115.60 | 2.27 | Positive | n.a |
4 | 60% | 115.80 | 2.27 | Positive | n.a |
Table: Individual ear Thickness and irritation level (main study)
Groups | Test item Animals | Day 1 eat thickness (mm) |
Day 3 eat thickness (mm) |
Day 6 eat thickness (mm) |
% of ear thickness increased/ day 1 |
irritation level |
1 |
Vehicule n°1 |
0.20 |
0.19 |
0.21 |
5.0 |
- |
|
Vehicule n°2 |
0.20 |
0.19 |
0.21 |
5.0 |
- |
|
Vehicule n°3 |
0.19 |
0.19 |
0.19 |
0.0 |
- |
|
Vehicule n°4 |
0.21 |
0.20 |
0.19 |
-9.5 |
- |
|
Mean |
0.20 |
0.19 |
0.20 |
0.1 |
- |
|
Standard deviation |
0.01 |
0.01 |
0.01 |
6.8 |
- |
2 |
20% - n°1 |
0.18 |
0.20 |
0.22 |
22.2 |
Slightly irritant |
|
20% - n°2 |
0.19 |
0.20 |
0.20 |
5.3 |
Slightly irritant |
|
20% - n°3 |
0.19 |
0.20 |
0.21 |
10.5 |
Slightly irritant |
|
20% - n°4 |
0.18 |
0.19 |
0.22 |
22.2 |
Slightly irritant |
|
Mean |
0.19 |
0.20 |
0.21 |
15.1 |
Slightly irritant |
|
Standard deviation |
0.01 |
0.01 |
0.01 |
8.5 |
Slightly irritant |
3 |
40% - n°1 |
0.20 |
0.21 |
0.23 |
15.0 |
Slightly irritant |
|
40% - n°2 |
0.21 |
0.21 |
0.24 |
14.3 |
Slightly irritant |
|
40% - n°3 |
0.19 |
0.20 |
0.24 |
26.3 |
Slightly irritant |
40% - n°4 | 0.19 | 0.20 | 0.22 | 15.8 | Slightly irritant | |
Mean | 0.20 | 0.21 | 0.23 | 17.8 | Slightly irritant | |
Standard deviation | 0.01 | 0.01 | 0.01 | 5.7 | Slightly irritant | |
4 | 60% - n°1 | 0.20 | 0.20 | 0.22 | 10.0 | Slightly irritant |
60% - n°2 | 0.20 | 0.20 | 0.22 | 10.0 | Slightly irritant | |
60% - n°3 | 0.19 | 0.19 | 0.23 | 21.1 | Slightly irritant | |
60% - n°4 | 0.19 | 0.20 | 0.22 | 15.8 | Slightly irritant | |
Mean | 0.20 | 0.20 | 0.22 | 14.2 | Slightly irritant | |
Standard deviation | 0.01 | 0.01 | 0.01 | 5.3 | Slightly irritant |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- In view of these results, under these experimental conditions, the test item Paraphenoxyphenol has to be classified as a sensitiser in Category 1, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
- Executive summary:
A test in accordance of OECD guideline n°429 was performed to assess the skin sensitization potential of the test item Paraphenoxyphenol in the CBA/J strain mouse following topical application to the dorsal surface of the ear.
Three groups of four animals were treated for the three consecutive days (D1, D2, D3) with 50 μL (25μL per ear) of the test item diluted in Acetone/olive oil (4:1 v/v) (AOO) at concentrations of 20%,
40% and 60%. A further group of four animals was treated with AOO On D6, the proliferation of lymphocytes in the draining auricular lymph nodes was determined by cell counting.
No mortality and no sign of systemic toxicity were noted in the treated and control animals during the test. No increase in ear weight was recorded at the concentrations of 20%, 40% and 60 %. Therefore, the test item has to be considered as not excessively irritant at these concentrations in accordance with the OECD criteria.
The stimulation increase (SI) calculated by pooled approach was 1.76, 2.27 and 2.27 for the treated groups at 20%, 40% and 60%, respectively. Therefore, the EC1.4 can not be determined due to the absence of SI value lower than 1.4.
In view of these results, under these experimental conditions, the test item Paraphenoxyphenol has to be classified as a sensitiser in Category 1, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
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