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EC number: 941-364-9 | 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1979-09-21 to 1979-10-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.
- Justification for type of information:
- Read across justification included in Section 13
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1979-09-21 to 1979-10-27
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.
- Justification for type of information:
- Read across justification included in Section 13
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- other: buehler type dermal application
- Justification for non-LLNA method:
- The available Buehler type test provides information on skin sensitisation potential by measuring challenge-induced dermal hypersensitivity reactions elicited in test animals compared with controls.
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Institute
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: housed in stainless steel cages with indirect bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of undiluted test material
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of undiluted test material
- No. of animals per dose:
- 10 treatment animals and 10 positive control animals
- Details on study design:
- RANGE FINDING TESTS: not reported
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: back
- Frequency of applications: three times per week
- Duration: three weeks
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after induction period
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: backs
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 hours - Positive control substance(s):
- yes
- Remarks:
- 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol
- Positive control results:
- No statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the control group.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Average erythema score of 1.3 and average oedema score of 0.3.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score of 1.3 and average oedema score of 0.3..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% w/v dilution of chlorodinitrobenzene in ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Average erythema score = 1.9, Average oedema score = 0.7
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% w/v dilution of chlorodinitrobenzene in ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score = 1.9, Average oedema score = 0.7 .
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control was not included i
- Remarks on result:
- other: negative control was not included
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.
- Executive summary:
In a skin sensitisation study, ten young adult male albino guinea pigs were exposed to 0.5 mL of undiluted diesel fuel (marketplace sample) in the treatment group and ten young adult male albino guinea pigs were exposed to 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol in the positive control group. Both groups were shaved in an area on their back. On the day of application, test material or positive control was placed on a gauze patch which was put on the shaved exposure site, covered with plastic wrap and wrapped with elastic bandaging. Bandaging and wrapping was removed 6 hours after application. The same procedure was replicated 3 times a week for 3 weeks (10 treatments in total). Two weeks after the last induction dose, a single challenge dose was administered following the same methods as used during the induction period, in both the treatment and positive control groups. Scoring of erythema and oedema was made at 24 hours after each application.
Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for wither erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.
Phase |
Average Dermal Irritation Score |
|||
API #79 -6 |
Positive Control |
|||
Erythema |
Oedema |
Erythema |
Oedema |
|
Induction Phase Average |
1.3 |
0.3 |
1.3 |
0.3 |
Challenge Phase Average |
1.3 |
0.3 |
1.9 |
0.7 |
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- other: buehler type dermal application
- Justification for non-LLNA method:
- The available Buehler type test provides information on skin sensitisation potential by measuring challenge-induced dermal hypersensitivity reactions elicited in test animals compared with controls.
Test material
- Reference substance name:
- Fuels, diesel
- EC Number:
- 269-822-7
- EC Name:
- Fuels, diesel
- Cas Number:
- 68334-30-5
- IUPAC Name:
- Fuels, diesel
- Reference substance name:
- Diesel fuel -marketplace sample
- IUPAC Name:
- Diesel fuel -marketplace sample
- Test material form:
- other: low viscosity hydrocarbon liquid
- Details on test material:
- - Name of test material (as cited in study report): API #79-6, diesel fuel (marketplace sample)
- Substance type: petroleum distillation product composed of hydrocarbon chains
- Physical state: liquid
- Analytical purity: not provided by sponsor
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 41.7% paraffins, 30.9% cycloparaffins, 27.4% aromatics
- Isomers composition: not reported
- Purity test date: not provided by sponsor
- Lot/batch No.: not reported
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not provided by sponser
- Storage condition of test material: 30 ml was removed from Elar's test material storage room, placed in an amber vial and kept in the study room for the duration of testing.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CAMM Research Institute
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: housed in stainless steel cages with indirect bedding
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported
IN-LIFE DATES: not reported
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of undiluted test material
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 mL of undiluted test material
- No. of animals per dose:
- 10 treatment animals and 10 positive control animals
- Details on study design:
- RANGE FINDING TESTS: not reported
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: back
- Frequency of applications: three times per week
- Duration: three weeks
- Concentrations: undiluted
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after induction period
- Exposure period: 6 hours
- Test groups: 10 animals in treatment group
- Control group: 10 animals in positive control group
- Site: backs
- Concentrations: undiluted
- Evaluation (hr after challenge): 24 hours - Positive control substance(s):
- yes
- Remarks:
- 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol
Results and discussion
- Positive control results:
- No statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the control group.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- undiluted
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Average erythema score of 1.3 and average oedema score of 0.3.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: undiluted. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score of 1.3 and average oedema score of 0.3..
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.05% w/v dilution of chlorodinitrobenzene in ethanol
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Clinical observations:
- Average erythema score = 1.9, Average oedema score = 0.7
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.05% w/v dilution of chlorodinitrobenzene in ethanol. No with. + reactions: 10.0. Total no. in groups: 10.0. Clinical observations: Average erythema score = 1.9, Average oedema score = 0.7 .
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- negative control was not included i
- Remarks on result:
- other: negative control was not included
Any other information on results incl. tables
Phase |
Average Dermal Irritation Score |
|||
API #79 -6 |
Positive Control |
|||
Erythema |
Oedema |
Erythema |
Oedema |
|
Induction Phase Average |
1.3 |
0.3 |
1.3 |
0.3 |
Challenge Phase Average |
1.3 |
0.3 |
1.9 |
0.7 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for either erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.
- Executive summary:
In a skin sensitisation study, ten young adult male albino guinea pigs were exposed to 0.5 mL of undiluted diesel fuel (marketplace sample) in the treatment group and ten young adult male albino guinea pigs were exposed to 0.05% (w/v) dilution of chlorodinitrobenzene in ethanol in the positive control group. Both groups were shaved in an area on their back. On the day of application, test material or positive control was placed on a gauze patch which was put on the shaved exposure site, covered with plastic wrap and wrapped with elastic bandaging. Bandaging and wrapping was removed 6 hours after application. The same procedure was replicated 3 times a week for 3 weeks (10 treatments in total). Two weeks after the last induction dose, a single challenge dose was administered following the same methods as used during the induction period, in both the treatment and positive control groups. Scoring of erythema and oedema was made at 24 hours after each application.
Results indicated no statistically significant differences between the mean of the averages of the ten sensitizing treatments and the mean of the challenge treatment for wither erythema or oedema in the test or control group. Based on this data, the test material is considered non-sensitising.
This study received a Klimisch score of 2 and is classified as reliable with restrictions because it was conducted similar to guideline study OECD 406.
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