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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 310-154-3 | CAS number: 121158-58-5
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1st October to 4th December 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study conducted to GLP. Background irritation was observed in the naive control animals.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study older than 2002 when TG LLNA adopted
Test material
- Reference substance name:
- Phenol, dodecyl-, branched
- EC Number:
- 310-154-3
- EC Name:
- Phenol, dodecyl-, branched
- Cas Number:
- 121158-58-5
- Molecular formula:
- Not appropriate. UVCB substance
- IUPAC Name:
- 4-(3,4,5,6-tetramethyloctan-2-yl)phenol
- Details on test material:
- - Physical state: slightly viscous, clear, brown liquid
- Expiration date of the lot/batch: 01-09-1997
- Storage condition of test material: room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: U.S.D.A. licensed supplier
- Age at study initiation: All test and primary challenge naive control animals were 6-11 weeks old (±5 days).
- Weight at study initiation: At the start of the induction phase of testing the test and primary challenge naive control animals weighed 370-481 grams. At the start of the re-challenge phase, the re-challenge naive control animals weighed 438-703 grams.
- Housing: Animals were individually housed in wire mesh suspension cages.
- Diet/water (e.g. ad libitum): Teklad Guinea Pig Diet and tap water were supplied ad libitum during both acclimation and test periods.
- Acclimation period: Prior to use, all animals were acclimated for at least seven days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 64-79° F
- Humidity (%): 30-70%.
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Pilot phase: undiluted test material and 50%, 25%, 10%, 5%, 2.5%, 1%, and 0.5% of the test material in mineral oil.
Induction phase: 2.5% of the test material in mineral oil.
Challenge phase: 1% of the test material in mineral oil.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Pilot phase: undiluted test material and 50%, 25%, 10%, 5%, 2.5%, 1%, and 0.5% of the test material in mineral oil.
Induction phase: 2.5% of the test material in mineral oil.
Challenge phase: 1% of the test material in mineral oil.
- No. of animals per dose:
- A total of 48 animals were utilized. Twenty test animals, twenty naive control animals, and eight pilot animals were used. Equal numbers of males and females were included in each animal group. The ten primary challenge naive control animals were common to this study.
- Details on study design:
- RANGE FINDING TESTS:
The irritation phase had the purpose of determining the proper level of test material to be used in the induction and challenge phases. The irritation potential of the test material at levels of undiluted, 50%, 25%, 10%, 5%, 2.5%, 1%, and 0.5% was evaluated in two groups of four animals each. Four levels of the test material were evaluated per animal such that each animal in a given pilot group was exposed to the same levels. Dilutions of the test material were formulated w/v in Mineral Oil (supplied by Chevron). The position of the different concentrations of the test material on the animals was varied to adjust for possible site-to-site variation in response.
The day prior to test material exposure, the hair was removed from each of the animal's backs using a small animal clipper. Closed patches were applied to the animals in the following manner: A 0.3 ml quantity of each test preparation was applied into a 25 mm Hill Top Chamber®. The animal was placed into the restrainer, and the chambers were applied to the clipped surface as quickly as possible. The chambers were occluded with rubber dental dam pulled taut and fastened to the bottom of the restrainer with clips. The restrainer was adjusted to minimize movement of the animal during exposure. Approximately six hours later, the dental dam and chambers were removed, and the animal was taken from the restrainer and placed in its cage. The day following the irritation exposure all animals were depilated and scored.
MAIN STUDY
A. INDUCTION EXPOSURE
The purpose of this phase was to dermally expose the animals so that, if the material was a sensitizer, the physiological process required to ultimately allow the generation of an immunological response could be initiated.
The left shoulder of each animal was clipped with a small animal clipper the day before exposure.
The animals were restrained, and a 0.3 ml quantity of the test preparation was applied using a Hill Top Chamber® as previously described above. The procedure was repeated at the same site once a week for the next two weeks for a total of three approximate six-hour exposures (the interval between induction exposures was seven days). After the last induction exposure, the animals were left untreated for approximately two weeks (14 days) before primary challenge.
B. CHALLENGE EXPOSURE
The purpose of this phase was to investigate the elicitation of response. The test animals, which had three previous exposures to the test material at appropriate intervals, were again exposed in the challenge phase approximately two weeks after the last induction exposure. In addition, ten naive animals, which had never been exposed to the test material, are concurrently treated with the same test material concentration.
The same exposure procedure as for the "Induction Phase" was used except the chambers were applied to a skin site that had not been exposed previously.
OTHER:
Re-challenge Phase:
The purpose of this phase was to confirm the responses noted during the primary challenge phase. The test animals, which had previous exposures to the test material at appropriate intervals, were again exposed in the re-challenge phase approximately one week after the primary challenge exposure. In addition, ten naive animals, which had never been exposed to the test material, were concurrently treated with the same test material concentration.
The same exposure procedure as for the "Primary Challenge Phase" was used, except the chambers were applied to a skin site that had not been exposed previously. - Challenge controls:
- yes
- Positive control substance(s):
- yes
Results and discussion
- Positive control results:
- Group 1 test animals received one induction treatment utilizing 1-CHLORO-2,4-DINITROBENZENE (DNCB) at a concentration of 0.3% formulated w/v in 95% ethanol. Approximately two weeks (14 days) following the induction treatment, a primary challenge treatment was conducted utilizing the ten test animals and five naive control animals. Each animal received 1-CHLORO-2,4-DINITROBENZENE (DNCB) at concentrations of 0.1%, 0.05%, and 0.01% formulated w/v in acetone.
Group 2 test animals received three induction treatments at weekly intervals utilizing a - Hexylcinnamaldehyde, tech., 85% at a concentration of 2.5% formulated w/v in 95% ethanol. Approximately two weeks (16 days) following the induction treatments, a primary challenge treatment was conducted utilizing the ten test animals and five naive control animals. Each animal received a - Hexylcinnamaldehyde, tech., 85% at concentrations of 5%, 2.5%, and 1.0% formulated w/v in acetone.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- rechallenge
- Group:
- positive control
- Dose level:
- Hexylcinnamaldehyde, tech., 85% at concentrations of 5%, 2.5%, and 1.0% formulated w/v in acetone.
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- other: Group 2
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- Hexylcinnamaldehyde, tech., 85% at a concentration of 2.5% formulated w/v in 95% ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- other: Group 2
- Key result
- Reading:
- rechallenge
- Group:
- positive control
- Dose level:
- 1-CHLORO-2,4-DINITROBENZENE (DNCB) at concentrations of 0.1%, 0.05%, and 0.01% formulated w/v in acetone.
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- other: Group 1
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 1-CHLORO-2,4-DINITROBENZENE (DNCB) at a concentration of 0.3% formulated w/v in 95% ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Not specified
- Remarks on result:
- other: Group 1
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1% w/v in mineral oil
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1 animal with slight but confluent, or moderate patchy erythema (1) and 9 animals with slight, patchy erythema (±)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1% w/v in mineral oil. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal with slight but confluent, or moderate patchy erythema (1) and 9 animals with slight, patchy erythema (±).
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% w/v in mineral oil
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- 1 animal with slight but confluent, or moderate patchy erythema (1) and 18 animals with slight, patchy erythema (±) and 1 animal was found dead.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% w/v in mineral oil. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: 1 animal with slight but confluent, or moderate patchy erythema (1) and 18 animals with slight, patchy erythema (±) and 1 animal was found dead..
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% w/v in mineral oil
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- 3 animals with slight but confluent, or moderate patchy erythema (1) and 17 animals with slight, patchy erythema (±)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 1% w/v in mineral oil. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: 3 animals with slight but confluent, or moderate patchy erythema (1) and 17 animals with slight, patchy erythema (±).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1% w/v in mineral oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- 10 animals with slight, patchy erythema (±)
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1% w/v in mineral oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: 10 animals with slight, patchy erythema (±).
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% w/v in mineral oil
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Clinical observations:
- 1 animal with slight but confluent, or moderate patchy erythema (1) and 18 animals with slight, patchy erythema (±) and 1 animal was found dead.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% w/v in mineral oil. No with. + reactions: 1.0. Total no. in groups: 19.0. Clinical observations: 1 animal with slight but confluent, or moderate patchy erythema (1) and 18 animals with slight, patchy erythema (±) and 1 animal was found dead..
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% w/v in mineral oil
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- 3 animals with slight but confluent, or moderate patchy erythema (1) and 17 animals with slight, patchy erythema (±)
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1% w/v in mineral oil. No with. + reactions: 3.0. Total no. in groups: 20.0. Clinical observations: 3 animals with slight but confluent, or moderate patchy erythema (1) and 17 animals with slight, patchy erythema (±).
Any other information on results incl. tables
See attached illustration.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test material was not considered a sensitizer in the Hartley guinea pig.
- Executive summary:
The potential of the test material as a 2.5% w/v in Mineral Oil to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler. Following primary challenge using the test material, as a 1% w/v formulation in Mineral Oil, the incidence of grade 1 responses in the test group (2 of 19) was compared to that of the naive control group (1 of 10). The incidence and severity of these responses in the test group were essentially comparable to those produced by the naive control group suggesting that sensitization had not been induced. However one test animal responded with a grade ± at the 24 hour reading which increased to a grade 1 at the 48 hour reading. This type of response is suspect as a sensitization type response. Therefore, a re-challenge was conducted to clarify the response noted during primary challenge.
Following re-challenge using the test material, as a 1% w/v formulation in Mineral Oil, the incidence of grade 1 responses in the test group (5 of 19) was compared to that of the naive control group (2 of 10). The incidence and severity of these responses in the test group were again essentially comparable to those produced by the naive control group. The failure of the test animals to exhibit a higher incidence of responses over that of the naive control group indicates that the responses noted are due to irritation and not sensitization. Therefore, it can be concluded that sensitization had not been induced.
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.