Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 947-623-2 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March - April 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD 404 guideline-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
- EC Number:
- 915-333-5
- IUPAC Name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
Constituent 1
- Specific details on test material used for the study:
- Of note, in the absence of specific data on the registered Reaction mass of o-(1-phenylethyl) phenol and bis(1-phenylethyl) phenol and 2,4,6-tris(1-phenylethyl)phenol and the obligation to generate some data for intermediates, data from the Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol have been included in the dossier by default as comparable hazard profile could be expected between both substances.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Conelli S.n.c., Via Milano 61, 28341 Arona (Novara) Italy
- Age at study initiation: 2 to 3 months
- Weight at study initiation: 2.5 to 2.8 kg
- Housing: in 62 x 47.5 x 38 cm metal cages with stainless steel feeders
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Yes (exact duration not specified)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 50 +/- 15
- Air changes (per hr): approximately 20/hour
- Photoperiod (hrs dark / hrs light): 12 / 12 (7 a.m. / 7 p.m.)
IN-LIFE DATES: From: March 4, 1997 To: March 7, 1997
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): Not applicable
VEHICLE
Not applicable - Duration of treatment / exposure:
- - 3 minutes (without patch) on one test site in one animal
- 1 hour (occlusive patch) on a second test site in the same animal
- 4 hours (occlusive patch) on a third test site in the same animal + 2 extra animals (3 total) - Observation period:
- - Immediately and 72 hours after application following 3-minute and 1-hour exposures
- 1, 24, 48 and 78 hours after application following 4-hour exposure - Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: approximately 6 cm²
- % coverage: Not specified
- Type of wrap if used: gauze patch loosely held in skin contact by an impermeable, non-irritant, hypoallergenic tape
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual substance wiped away
- Time after start of exposure: At the end of each exposure period
SCORING SYSTEM:
Skin reaction was scored using the following scale (according to Draize) :
- Erythema and eschar formation (maximum possible 4):
0 = No erythema
1 = Very slight (barely perceptible) erythema
2 = Well-defined erythema
3 = Moderate to severe erythema
4 = Severe erythema (beef redness) to slight eschar formation (injuries in depth)
- Edema formation (maximum possible 4):
0 = No edema
1 = Very slight (barely perceptible) edema
2 = Slight edema (area edges well defined by definite raising)
3 = Moderate edema (raised approximately 1 mm)
4 = Severe edema (raised more than 1 mm and extending beyond exposure area)
Dermal irritation was evaluated in conjunction with the nature and reversibility or otherwise of the responses observed.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: Not applicable
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- See table below
- Other effects:
- No other effect observed
Any other information on results incl. tables
Animal number | 1 | 2 | 3 | |||
Exposure duration | 3 min | 1 h | 4 h | 4 h | 4 h | |
Erythema score at | 3 min | 0 | NP | NP | NP | NP |
1 h | NP | 0 | 0 | 1 | 0 | |
24 h | NP | NP | 0 | 0 | 0 | |
48 h | NP | NP | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 | |
Edema score at | 3 min | 0 | NP | NP | NP | NP |
1 h | NP | 0 | 0 | 0 | 0 | |
24 h | NP | NP | 0 | 0 | 0 | |
48 h | NP | NP | 0 | 0 | 0 | |
72 h | 0 | 0 | 0 | 0 | 0 |
NP: Not Performed
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The very slight erythema observed in 1 out of 3 rabbits one hour after a 4-hour occlusive patch application of the test substance was isolated, reversible and was therefore considered incidental. As no other local change was observed, the test item was considered as non irritant and therefore not classified for skin irritation according to the criteria of Annex VI Directive 67/748/EEC or UN/EU GHS.
- Executive summary:
In a primary dermal irritation study (RBM study No. 970073), three male New Zealand White rabbits (2- to 3-month old), were dermally exposed to 0.5 mL of Tristyrenated phenol/Distyrenated phenol (75/25 molar %) applied as such for 3 minutes (one rabbit), 1 hour (same rabbit) or 4 hours (all 3 rabbits) to a clipped skin surface area of approximately 6 cm² on the trunk of the animals. Test sites were covered with an occlusive dressing for the duration of exposure. Local changes at application sites were then observed immediately and 72 h after the 3-min and 1-h exposures, and 1, 24, 48 and 72 h after the 4-h exposure. Local irritation was evaluated by scoring erythema/eschar and edema formation for each rabbit, according to Draize's method.
A very slight erythema (grade 1) was observed in one out of 3 rabbits one hour after the 4-hour occlusive patch application. As this finding was isolated and reversible, it was considered incidental. As no other local change was observed, the test item was considered as non irritant to the skin.
In this study, Tristyrenated phenol/Distyrenated phenol (75/25 molar %) is not a dermal irritant based on the absence of relevant local changes following occlusive patch application for up to 4 hours.
TSP/DSP is not classified for skin irritation according to the criteria of Annex VI Directive 67/748/EECor UN/EU GHS.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.