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Diss Factsheets
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EC number: 931-250-7 | 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because it is an acceptable and well-documented study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- 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.
Test material
- Reference substance name:
- 64742-81-0
- IUPAC Name:
- 64742-81-0
- Reference substance name:
- straight run kerosine
- IUPAC Name:
- straight run kerosine
- Test material form:
- other: low viscosity liquid hydrocarbon
- Details on test material:
- Straight run kerosine (F-131)
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Mineral oil
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Mineral oil
- No. of animals per dose:
- 10
- Details on study design:
- 1st application: Induction undiluted occlusive epicutaneous
2nd application: Challenge 50 % occlusive epicutaneous - Positive control substance(s):
- yes
- Remarks:
- dinitrochlorobenzene
Results and discussion
- Positive control results:
- DNCB evoked an acceptable positivve response
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1:2 v/v dilution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Severity Index (erythema + oedema) = 0.0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1:2 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1:2 v/v dilution challenge control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- Severity Index (erythema + oedema) = 0.0
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1:2 v/v dilution challenge control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1:2 v/v dilution
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Severity Index (erythema + oedema) = 0.0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1:2 v/v dilution . No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1:2 v/v dilution challenge control
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Clinical observations:
- Severity Index (erythema + oedema) = 0.0
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1:2 v/v dilution challenge control. No with. + reactions: 0.0. Total no. in groups: 4.0. Clinical observations: Severity Index (erythema + oedema) = 0.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.3% DNCB
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: all animals reacted to challenge
Any other information on results incl. tables
The
scores after the challenge treatment are summarised below
Group |
Time |
Severity range |
Incidence |
Test material |
24 h |
0 |
0/10 |
|
48 h |
0 |
0/10 |
Test control |
24 h |
0 |
4/4 |
|
48 h |
0 |
4/4 |
DNCB positive |
24 h |
4-6 |
10/10 |
|
48 h |
2-5 |
10/10 |
DNCB negative |
24 h |
0-2 |
4/4 |
|
48 h |
0-3 |
4/4 |
Mineral oil |
24 h |
0 |
0/4 |
|
48 h |
0 |
0/4 |
On the basis of the above response, the test material was not sensitizing.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test substance was classified as not sensitising.
- Executive summary:
In a sensitisation study, test material was applied to the occluded skin of a group of 10 guinea pigs. Six hours after application, the patches were removed and an evaluation of skin response using the Draize scale was made 24 and 48 hours after patch application. A further group of 10 animals were treated with Dinitrochlorobenzene (DNCB) and these animals served as the positive control group. This procedure was repeated on the same test sites once each week for 3 weeks. Thirteen days after the last induction dose, test material or DNCB was again applied to the occluded skin on a fresh test site of either the test or positive control animals. Patches were removed after six hours and the test sites were assessed and scored for reaction 24 hours after patch application. At challenge, previously untreated groups of 4 animals were treated with either test material, DNCB or vehicle; these served as negative controls.
Response grades, including incidence and severity, at challenge phase were less than or equivalent to responses during induction phase. The responses of the treatment animals were the same as the challenge control group. Positive control groups responses indicate that a sensitising response occurred; therefore, DNCB is classified as a delayed contact sensitiser. However, under the conditions of this study, the test material is not a sensitising agent.
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