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EC number: 270-728-3 | CAS number: 68477-39-4 A complex combination of hydrocarbons obtained by distilling cracked stripped steam-cracked distillates. It consists of hydrocarbons having carbon numbers in the range of C8 through C10 and boiling in the range of approximately 129°C to 194°C (264°F to 382°F).
- 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
It can be concluded that low benzene naphtha streams are irritating to rabbit skin but not irritating to the rabbit eye. Data for the specific component toluene is consistent with this classification. In addition it is noted that the exposure to this C7-C12 petroleum-derived aromatic stream was more severe than required by the test guidelines (24 hr contact time under occluded conditions), and therefore classification is based on data obtained for the specific low benzene naphtha stream in this category.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- In Vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting but otherwise adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4470 (Acute Dermal Irritation)
- Deviations:
- yes
- Remarks:
- occlusive dressing used
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sterling Rabbitry, Wellsville, Utah, USA.
- Age at study initiation: Young adult
- Weight at study initiation: 2.0-4.0 kg
- Housing: Individually in stainless steel, wire mesh bottom cages.
- Diet: Fresh certified Agway rabbit feed ad libitum
- Water: Fresh potable water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 61-71°F
- Humidity: 40-60%
- Air changes: At least 10 per hr
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: 5 February 1990 To: 8 February 1990 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area (approximately 1 square inch).
- Type of wrap if used: gauze patch taped with hypoallergenic tape and wrapped with an impervious, non-reactive rubberised material and taped in place.
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: scores at all time points
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: scores at all time points
- Interpretation of results:
- other: Irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- E000144700 is irritating but not corrosive to the skin.
- Executive summary:
The primary dermal irritation of E000144700 (CAS 68516-20-1) was investigated in a group of 6 albino rabbits. 0.5 mL of neat test substance was applied to approximately 1 square inch of shaved dorsal skin and retained in contact for 4 hours under an occlusive dressing. Erythema and oedema was seen in all six animals from 1 hour until 72 hours after removal of the dressing. Mean erythema and oedema scores over 24, 48 and 72 hours were greater than 2.
E000144700 (CAS 68516-20-1) is irritating to rabbit skin and warrants classification Category 2, H315 under GHS/CLP.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Remarks:
- In Vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, minor restrictions reporting but otherwise adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4500 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: Sterling Rabbitry, Wellsville, Utah, USA.
- Age at study initiation: Young adult
- Weight at study initiation: 2.0-4.0 kg
- Housing: Individually in stainless steel, wire mesh bottom cages.
- Diet: Fresh certified Agway rabbit feed ad libitum
- Water: Fresh potable water ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 61-71°F
- Humidity: 40-60%
- Air changes: At least 10 per hr
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: 20 February 1990 To: 23 February 1990 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- SCORING SYSTEM: Based on the Draize scale
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: no effects
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: no effects
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: effects in all 6 rabbits 1, 24 and 48 hours, in 5 rabbits at 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: effects in all 6 rabbits 1, 24 and 48 hours, in 5 rabbits at 72 hours
- Interpretation of results:
- other: Not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- E000144700 is not irritating to the rabbit eye.
- Executive summary:
Eye irritation potential of E000144700 (CAS 68516-20-1) was determined in a group of six albino rabbits. There was no evidence of damage to the cornea or iris throughout the study. Conjunctival redness and chemosis was seen from 1 hour to 72 hours after application. Mean scores over 24, 48 and 72 hours were: cornea 0, iris 0, conjunctival redness 1.6, chemosis 1.3.
E000144700 (CAS 68516-20-1) was not irritating to the rabbit eye and does not warrant classification under Dir 67/548/EEC or GHS CLP.
Reference
After 1, 24 and 48 hours, conjunctival redness and chemosis were present in all six rabbits, after 72 hours these conditions still persisted in five animals. Conjunctival discharge was present in one rabbit only at the 1 hour reading. There was no corneal or iridial involvement in any animal.
Table 1: Eye irritation scores
Time |
Cornea |
Iris |
Conjunctiva |
|||||||||||||||||||||
Redness |
Chemosis |
|||||||||||||||||||||||
Animal number |
91 |
95 |
101 |
104 |
105 |
106 |
91 |
95 |
101 |
104 |
105 |
106 |
91 |
95 |
101 |
104 |
105 |
106 |
91 |
95 |
101 |
104 |
105 |
106 |
after 1 hour |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
2 |
2 |
3 |
3 |
2 |
3 |
1 |
2 |
1 |
1 |
2 |
after 24 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
3 |
1 |
2 |
2 |
2 |
2 |
2 |
1 |
2 |
1 |
1 |
2 |
after 48 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
2 |
2 |
2 |
2 |
1 |
1 |
1 |
1 |
2 |
after 72 hours |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
0 |
1 |
2 |
1 |
2 |
2 |
0 |
1 |
1 |
1 |
2 |
mean scores 24-72h |
0 |
0 |
1.6 |
1.3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Non human data
Skin irritation
Skin irritation studies are available for one low benzene naphtha stream. CAS 68516-20-1 was concluded to be irritating, but not corrosive, to rabbit skin. The skin irritation potential of toluene was assessed in 7 rabbits according to EU method B4 (Exxon, 1988). Toluene caused significant inflammation of the skin and was classified as irritating to skin.
Eye irritation
Eye irritation studies are available for one low benzene naphtha stream. This stream (CAS 68516-20-1) was concluded not to be irritating to the rabbit eye. Data on the specific component toluene indicates that instillation of liquid test substance into the eye may induce some evidence of eye irritation but not of a severity that warrants labelling (Exxon, 1995).
Respiratory irritation
There are no specific data on low benzene naphtha streams or on toluene relating to irritation of the respiratory system.
Human information
There is no specific human information concerning skin or eye irritation on the low benzene naphtha streams. Although no data have been found for toluene, the EU RAR (2003) stated “it is well known that toluene has a degreasing effect on the skin. After repeated exposures, toxic contact dermatitis may develop. ”
There are no data from direct exposure of human eyes to liquid toluene. In a recent study, Muttray et al (2005) exposed twenty healthy men to a constant level of 50 ppm toluene. Acute symptoms related to eye irritation were assessed with the Swedish Performance Evaluation System (SPES) self-assessment questionnaire, once before and 3 times during exposure. Values obtained during exposure were related to pre-exposure values. There was no effect of toluene exposure on "irritation to the eye", "watering eyes" or "blurred vision”. 50 ppm (188 mg/m3) toluene is a NOAEC for eye irritation in humans.
References
EU RAR (2003a). European Union Risk Assessment Report for Toluene. EC Joint Research Centre http: //ecb. jrc. ec. europa. eu/DOCUMENTS/Existing- Chemicals/RISK_ASSESSMENT/REPORT/toluenereport032. pdf
Exxon (1988). Primary dermal irritation study in the rabbit. Testing laboratory: Exxon Biomedical Sciences, Toxicology Laboratory, Mettlers Road, CN 2350, East Millstone, New Jersey 08875-2350. Owner company: Exxon. Study number: 225904. Report date: 1988-07-29.
Exxon (1995). Ocular irritation study in the rabbit without eyewash with toluene (compliant with OECD test guideline 405). Testing laboratory: Exxon Biomedical Sciences Inc, Toxicology laboratory, Mettlers Road, CN 2350, East Millstone, New Jersey 08875-2350. Owner company: Exxon. Study number: 191813.
Muttray A, Spelmeyer U, Hommel G, Oesch F, Jung D, Rose D, Mayer-Popken O, Rossbach B and Letzel S (2005). Acute exposure to 50 ppm toluene does not increase sleepiness. Environ. Toxicol. Pharmacol. 19, 665-669.
Justification for selection of skin irritation / corrosion
endpoint:
Skin irritation data for representative streams, together with
information on the key marker substance toluene, indicate that members
of this category will be irritating to skin.
Justification for selection of eye irritation endpoint:
Eye irritation data for representative streams, together with
information on the key marker substance toluene, indicate that members
of this category will not be irritating to the eye.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
There are sufficient data on the low benzene naphtha stream and CAS 68516-20-1 and the specific component, toluene, to indicate that low benzene naphtha streams are irritating to rabbit skin but not irritating to the eye and should be classified as Category 2 H315 according to CLP.
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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