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EC number: 701-149-0 | 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1985/11/18 - 1986/01/03
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report in agreement with OECD guideline 406-GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The first-choice method according to REACH Annex VII §8.3, the Murine Local Lymph Node Assay, is known to give false positive results with hydrocarbon substances.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Laboratory Animals, Wayne, NJ 07470
- Age at study initiation: young adults
- Weight at study initiation: 284-331g
- Housing: individually
- Diet (e.g. ad libitum): fresh Certified Purina guinea pig chow #5026, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days, induction phase animals; 7 days, dose selection phase animals
ENVIRONMENTAL CONDITIONS
-Temperature: 64 to 74 degrees F
-Humidity: 29 to 62 percent relative humidity
-Photoperiod: 12hrs dark/12hrs light - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 0.5 ml, neat
Challenge: 0.5 ml, neat - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction: 0.5 ml, neat
Challenge: 0.5 ml, neat - No. of animals per dose:
- Dose selection: 6
Induction/challenge: 20
Challenge control: 8 - Details on study design:
-
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 1 (receiving 0.5 ml of undiluted test article)
- Control group: 2 (challenge control and positive control (0.3% DNCB in 80% ethanol/water))
- Site: along a side of the dorsal midline
- Frequency of applications: Weekly
- Duration: Three weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 14 post induction applications
- Exposure period: 6 hours
- Test groups: 1 (receiving 0.5 ml of undiluted test article)
- Control group:2 (Challenge control and positive control (0.2% DNCB in 80% ethanol/water))
- Site: Naive area along a side of the dorsal midline
- Evaluation (hr after challenge): 24- and 48-hours post-application, challenge sites were scored for erythema and edema according to the Draize technique - Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene (2,4 DNCB)
- Positive control results:
- Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group.
DNCB:
Challenge: 24 h reading: 3.2 (response grade), 10/10 animals
48 h reading: 2.4 (response grade), 10/10 animals - Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 mL neat
- No. with + reactions:
- 9
- Total no. in group:
- 9
- Clinical observations:
- Avg. combined erythema/edema score = 2.0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.5 mL neat. No with. + reactions: 9.0. Total no. in groups: 9.0. Clinical observations: Avg. combined erythema/edema score = 2.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 mL neat
- No. with + reactions:
- 8
- Total no. in group:
- 9
- Clinical observations:
- Avg. combined erythema/edema score = 0.9
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.5 mL neat. No with. + reactions: 8.0. Total no. in groups: 9.0. Clinical observations: Avg. combined erythema/edema score = 0.9.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: challenge control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Avg. combined erythema/edema score = 2.0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: challenge control. Dose level: 0.5 mL. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Avg. combined erythema/edema score = 2.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: challenge control
- Dose level:
- 0.5 mL
- No. with + reactions:
- 4
- Total no. in group:
- 4
- Clinical observations:
- Avg. combined erythema/edema score = 1.2
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: challenge control. Dose level: 0.5 mL. No with. + reactions: 4.0. Total no. in groups: 4.0. Clinical observations: Avg. combined erythema/edema score = 1.2.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the test, the test article F-64-01 was not a delayed contact sensitizer and the positive control DNCB was a delayed contact sensitizer.
- Executive summary:
Male Hartley Albino guinea pigs were dermally exposed to test article F-64-01 neat at a volume of 0.5 ml for each of three induction phases. For the challenge phase, the test article was administered undiluted for both the induction/challenge and challenge control group animals. Response grades, severity and incidence at the time of the challenge exposure for the test article F-64-01 indicated no dermal responsiveness in the induction/challenge group above that observed in the naive challenge control group. The naive challenge irritation control group animals were also free of any dermal response. Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group.
Under the conditions of the test, the test article F-64-01 was not a delayed contact sensitizer and the positive control DNCB was a delayed contact sensitizer.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented study report similar or equivalent to OECD 406. GLP.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction dose: 0.5 ml, neat
Challenge dose: 0.5 ml, 1:2 dilution in mineral oil
Positive Control DNCB:
Induction/Challenge: 0.05% DNCB in ethanol - Route:
- epicutaneous, occlusive
- Vehicle:
- other: mineral oil
- Concentration / amount:
- Induction dose: 0.5 ml, neat
Challenge dose: 0.5 ml, 1:2 dilution in mineral oil
Positive Control DNCB:
Induction/Challenge: 0.05% DNCB in ethanol - No. of animals per dose:
- 10 males for induction/challenge
- Details on study design:
- A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Frequency of applications: three times per week
- Duration: 3 weeks
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: Day 14 post-induction application
- Exposure period: 6 hours
- Evaluation (hr after challenge): 24 and 48 hr
OTHER: response grade score = erythema + edema - Challenge controls:
- Naive guinea pigs receiving only the challenge dose in order to distinguish between “background” irritation response and actual allergenic response.
- Positive control results:
- Most of the positive control group animals showed evidence of sensitization.
- Remarks on result:
- other: see Any other information on results below
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Unleaded motor gasoline (API PS-6) did not induce a sensitisation response in guinea pigs in this study. This finding does not warrant the classification of the test article as a skin sensitiser under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
- Executive summary:
Male Hartley Albino guinea pigs were dermally exposed to unleaded motor gasoline (API PS-6), neat, at a volume of 0.5 ml for each of the three induction phases. For the challenge phase, unleaded motor gasoline was administered as a 1:2 dilution in mineral oil for the challenge and challenge control group animals. Response grades, severity and incidence at the time of the challenge exposure for the test article indicated no dermal responsiveness in the induction/challenge group above that observed in the naive challenge control group. Response grades, severity and incidence at the time of the challenge exposure for DNCB resulted in a significantly higher response in the induction/challenge group than that observed in the naive challenge control group. This finding does not warrant the classification of unleaded motor gasoline (API PS-6) as a skin sensitiser under Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Referenceopen allclose all
Since the challenge treatment did not produce scores higher than the sensitizing treatment, the test substance was considered to be non-sensitizing.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a read-across sensitisation study with gasoline, there was no evidence of dermal sensitization in a Buehler test in guinea pigs
Migrated from Short description of key information:
Skin sensitization – Not sensitizing in guinea pig (OECD TG 406).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a read-across guinea pig sensitisation study with gasoline there was no evidence of dermal sensitisation. Thus, the data available do not support classification as a sensitiser according to EU CLP Regulation (EC No. 1272/2008).
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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