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Phenol, paraalkylation products with C10-15 branched olefins (C12 rich) derived from propene oligomerization, carbonates, calcium salts, overbased, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalytic dewaxed, light or heavy paraffinic C15-C50
EC number: 701-251-5 | 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
Endpoint summary
Administrative data
Description of key information
Skin:
The test material caused slight to well-defined erythema and oedema through 24 hours after the test material was removed. On Days 2 and 3, slight to moderate erythema was observed. Slight erythema was observed in some animals on Day 7. All sites were clear of irritation on Day 14. The primary irritation score was 1.6.
The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 1 and so will not be classified as irritating.
Eye:
Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.
The Maximum Average Score for the test material was 5.3 at one-hour post-instillation.
The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3rd to 17th December 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Not conducted to a recognised guideline however methods well written and look similar to OECD 404. Conducted to GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: L.I.T. Rabbitry, Whitehall, Montana
- Age at study initiation: The animals were 17-19 weeks of age at the time of dosing.
- Housing: The animals were housed individually in wire-bottom cages in an air conditioned room.
- Diet (e.g. ad libitum): The animals were fed a daily ration of Purina Laboratory Rabbit Chow HF #5326.
- Water (e.g. ad libitum): Free access to water.
- Acclimation period: Conditioning period of nine weeks prior to dosing.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.8-22.3°C
- Humidity (%): 18.2-62.7%
- Photoperiod (hrs dark / hrs light): The photoperiod was a 12-hour light/dark cycle: lights on at 0630 and off at 1830. - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: shaved and both abraded and unabraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- The test material was delivered neat.
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours, 7 and 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: One-half milliliter of the test material was applied to each of two intact and two abraded sites on the back of each rabbit.
- Type of wrap if used: After application, each treated site was covered with a gauze patch secured in place by porous tape. The trunk of each animal was loosely wrapped in a plastic sheet, and paper toweling was wrapped around the plastic sheet to prevent tearing. A collar was also placed on each animal to protect the wrappings during the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with mineral oil and a gauze pad to remove any remaining test material.
- Time after start of exposure: 4 hours
SCORING SYSTEM:
Irritation was scored at 1, 24, 48, and 72 hours after removal of the test material and at 7 and 14 days, using the modified scoring method of Draize et al. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 1.6
- Remarks on result:
- other: Sum of the combined individual scores for erythema and edema at each site at 1, 24, and 72 hours divided by 72 observations.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 0.9
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- other: Intact Skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: Intact Skin
- Irritant / corrosive response data:
- The test material caused no to well-defined erythema and edema one hour after the test material was removed. Slight to well-defined erythema was observed at 24 hours; slight edema was also seen at one treatment site. No to moderate erythema was observed 48 and 72 hours after removal of the test material. On Day 7, slight erythema was observed at four sites. Flakiness was seen at the majority of the application sites. All sites were clear of irritation on Day 14. However, one animal had flaky skin at all four application sites.There was no difference in irritation between intact and abraded sites.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary irritation score was 1.6.
- Executive summary:
One-half milliliter of the test material was applied to two intact and two abraded areas on the back of each of six rabbits for four hours. The test material caused slight to well-defined erythema and edema through 24 hours after the test material was removed. On Days 2 and 3, slight to moderate erythema was observed. Slight erythema was observed in some animals on Day 7. All sites were clear of irritation on Day 14. The primary irritation score was 1.6.
The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 1 and so will not be classified as irritating according to CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16th to 25th December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study following GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc. Denver, PA
- Age at study initiation: Young adult
- Weight at study initiation: 2746 to 2999 grams at initiation of dosing
- Housing: Individual suspended wire mesh cages. The animals were maintained by the animal husbandry staff of WIL Research Laboratories, Inc. in accordance with standard operating procedures.
- Diet (e.g. ad libitum): PMI Nutrition International, Inc. Certified Rabbit LabDiet® 5322 was offered at approximately 150 g per day during the study. Analysis of feed was performed and provided by the manufacturer.
- Water (e.g. ad libitum): Municipal water was provided ad libitum. Water was analyzed in accordance with standard operating procedures. Contaminants were not present in animal feed or water at levels expected to interfere with the objective of this study.
- Acclimation period: The animals were acclimated to laboratory conditions for a minimum of seven days prior to initiation of dosing.
ENVIRONMENTAL CONDITIONS
- Temperature: 68.2-68.8°F
- Humidity (%): 30.2-44.1%
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 ml/right eye
- Duration of treatment / exposure:
- The test article was placed directly into the cupped lower conjunctival sac of each rabbit's right (test) eye. The eyelids were held closed for approximately one second after instillation. Left eyes were manipulated in an identical manner to simulate the dosing of the right eyes.
- Observation period (in vivo):
- Treated eyes were examined at 24, 48 and 72 hours and on Days 4 and 7 following treatment according to the Draize methodology. The rabbits were observed twice daily (morning and afternoon) for mortality for the duration of the study.
- Number of animals or in vitro replicates:
- six, 2 males/4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Unwashed exposure.
SCORING SYSTEM:
Both eyes of all rabbits were examined macroscopically for ocular irritation in accordance with the method of Draize at approximately one, 24, 48 and 72 hours after dosing and on days 4 and 7 if irritation persisted.
TOOL USED TO ASSESS SCORE:
An ophthalmoscope was used during these observations to examine the corneal tissue. In addition, both eyes were further examined at 72 hours and on day 7 with sodium fluorescein. - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 1 hour after instillation of test material
- Score:
- 5.3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 & 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no effects seen
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 1.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.
M.A.S. - Maximum Average Score for 1 hour was 5.3. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.
- Executive summary:
In an eye irritation study conducted to OED method 405 in compliance with GLP, the primary ocular irritation potential of the test material was evaluated with New Zealand White rabbits.
There was one group of six albino rabbits that received a single, unwashed exposure. Each 0.1-m1 dose of the test article was instilled into the lower conjunctival sac of the right eye. The eyelid was held closed for approximately one second and released. The left eye was manipulated in a similar manner as the right eye and served as a contralateral control.
The eyes were examined for ocular reactions in accordance with the method of Draize at approximately one, 24, 48 and 72 hours after dosing and on days 4 and 7 if irritation persisted. Sodium fluorescein was used to aid in revealing possible corneal damage at 72 hours and on day 7.
Conjunctival irritation, including positive irritation (grade 2) for four rabbits, was noted for all animals. There were no iridal or corneal findings in the treated eyes. All conjunctival irritation completely subsided by day 7.
The Maximum Average Score for the test material was 5.3 at one-hour post-instillation.
The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating according to CLP.
Reference
There were no deaths during the study.
The left (control) eyes were free of evidence of ocular irritation and other findings for the duration of the study.
There were no remarkable body weight changes noted during the study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
The key study Brorby, 1986 (Chevron report number: SOCAL 2503) was comparable to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and was conducted to GLP. Although there was no guideline stated, the study predates OECD 404 and basic scientific principles are similar to recognised guidelines.
A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997. This was considered to be the most reliable study and is also the most recent study available. Classification has been based on the results from this study.
- The Hirose et al study, 1986 (Chevron report number: SOCAL 2433A) was identical in methodology to the above key study. Although there was no guideline stated, the study predates OECD 404 and basic scientific principles are similar to recognised guidelines. The study was considered to have a reliability rating of 1, according to the criteria of Klimisch, 1997.
The primary irritation score was 1.3. The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 0.2 and so will not be classified as irritating.
- The Meyding et al study, 1962a (Hazleton report number: 20-0169-33) was not conducted according to a recognised guideline or GLP. There are also significant deviations affecting this study such as the test substance being left on for 24 hours rather than 4 hours as suggested in recognised guidelines, and also the test material was not removed with an appropriate solvent after exposure. The study was therefore considered to have a reliability rating of 3, according to the criteria of Klimisch, 1997.
The test material produced a moderate degree of irritation characterized by erythema and edema involving both intact and abraded skin areas. Little improvement was observed at the 72-hour observation for although the edema had significantly subsided, erythema increased and substantial drying of the skin occurred. The primary dermal irritation index of the test material was 3.8.
- The Meyding et al study, 1962b (Hazleton report number: 20-0169-33) was not conducted according to a recognised guideline or GLP. There are also significant deviations affecting this study such as the test substance being left on for 24 hours rather than 4 hours as suggested in recognised guidelines, and also the test material was not removed with an appropriate solvent after exposure. The study was therefore considered to have a reliability rating of 3, according to the criteria of Klimisch, 1997.
The primary dermal irritation index of the test material is 6.2.
The test compound produced a severe reaction on both the intact and abraded surfaces. Maximum scores for edema and erythema were frequently observed; the irritation had not subsided appreciably by the 72-hour observation period.
- The Brett, 1975 study was conducted according to the Federal Hazardous Substance Act (16 CFR 1500). A reliability rating of 3 was assigned according to the criteria of Klimisch, 1997 due to the following deviations: The study employed a 24 hour exposure instead of the standard 4 hour exposure. No details of test material removal from the skin. The information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable.
- The Exxon Biomedical Sciences study, 1992 was comparable to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and was conducted to GLP.
The test substance was removed using water and due to the low solubility of the test material it is unlikely that this method will have fully removed the test material from the test sites, therefore a reliability rating of 3, according to the criteria of Klimisch, 1997 was assigned.
primary irritation index = 2.42.
The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 1.1 and so will not be classified as irritating according to CLP.
- The Exxon Biomedical Sciences study, 1986 was comparable to the OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and was conducted to GLP.
The test substance was removed using water and due to the low solubility of the test material it is unlikely that this method will have fully removed the test material from the test sites, therefore a reliability rating of 3, according to the criteria of Klimisch, 1997 was assigned.
primary irritation index = 5.33.
The mean value of the scores for erythema and edema formation for 24, 48 and 72 hours was calculated to be 2.6 and would meet the classification criteria but this study was not considered reliable and so will not be taken into account when classifying the substance.
Eye:
The Kern, 2000 study (Report number: WIL-168178) was chosen as the key study for eye irritation as it was conducted to the OECD Guideline 405 (Acute Eye Irritation / Corrosion) and GLP. A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997. This was considered to be the most reliable study and is also the most recent study available. Classification has been based on the results for this study.
The other supporting studies available are as follows:
- The Brorby et al study, 1986 (Chevron report number: SOCAL 2325) was not considered the key study as it was conducted less recently than the above key study. There was no guideline stated, however the study predates OECD 405 and basic scientific principles look comparable to recognised guidelines. A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997.
The mean value of the scores for cornea opacity, iris lesions, redness & oedema of the conjuctivae, for 24, 48 and 72 hours was calculated and was considered to be non-irritating CLP criteria.
- The Meyding et al study, 1962b (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Methods and results were reported. The study was considered to have a reliability rating of 4, according to the criteria of Klimisch, 1997 as observations were not carried out for long enough to enable revesibility of irritation and although methods and results were reported the conjunctivae scores were combined in the results and therefore it was not possible to classify according to current labelling guides and so this study was considered unassignable. The test material produced a significant degree of eye irritation in rabbits which has not completely subsided within 72 hours following instillation.
- The Meyding et al study, 1962a (Hazleton report number: 20-0169-33) was not considered the key study as it was conducted less recently than the above key study and was not conducted according to a recognised guideline or GLP. Methods and results were reported. The study was considered to have a reliability rating of 4, according to the criteria of Klimisch, 1997 as observations were not carried out for long enough to enable revesibility of irritation and although methods and results were reported the conjunctivae scores were combined in the results and therefore it was not possible to classify according to current labelling guides and so this study was considered unassignable. The test material produced a significant degree of eye irritation in rabbits which has not completely subsided within 72 hours following instillation.
- The Brett, 1975 study was conducted according to the Federal Hazardous Substance Act (16 CFR 1500.42). A reliability rating of 4 was assigned according to the criteria of Klimisch, 1997 due to the following deviations: The information was obtained from the peer reviewed, 2006 OECD SIDS dossier due to the original report being unavailable.
- The Exxon Biomedical Sciences study, 1984 was comparable to the OECD Guideline 405 (Acute Eye Irritation / Corrosion).
A reliability rating of 1, according to the criteria of Klimisch, 1997
was assigned. Ocular instillation of the test material elicited only
conjunctival responses, including redness, chemosis and discharge. All
animals were clear of irritation by the Day 7 observation. The mean
value of the scores for cornea opacity, iris lesions, redness & oedema
of the conjuctivae, for 24, 48 and 72 hours was calculated and was
considered to be non-irritating according to CLP.
Justification for classification or non-classification
Multiple studies demonstrated that skin irritation was well below the classification criteria for both skin and eye irritation.
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